WHO approves first mpox diagnostic test for emergency use, boosting global access

The World Health Organization (WHO) has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, an important step in improving global access to mpox testing. The approval for emergency use of the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., will be pivotal in expanding diagnostic capacity in countries facing mpox outbreaks, where the need for quick and accurate testing has risen sharply. Early diagnosis of mpox enables timely treatment and care, and control of the virus.

Limited testing capacity and delays in confirming mpox cases persist in Africa, contributing to the continued spread of the virus. In 2024, over 30 000 suspected cases have been reported across the region, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria. In the Democratic Republic of the Congo, only 37% of suspected cases have been tested this year.

The presence of the monkeypox virus is confirmed by nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR), as stated in the WHO Interim Guidance on Diagnostic testing for the monkeypox virus (MPXV). And the recommended specimen type for diagnostic confirmation of monkeypox virus (MPXV) infection in suspected cases is lesion material.

The Alinity m MPXV assay is a real-time PCR test that enables detection of monkeypox virus (clade I/II) DNA from human skin lesion swabs. It is specifically designed for use by trained clinical laboratory personnel who are proficient in PCR techniques and IVD procedures. By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected mpox cases efficiently and effectively.

“This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions.”

The EUL process accelerates the availability of life-saving medical products, such as vaccines, tests and treatments, in the context of a Public Health Emergency of International Concern (PHEIC). On 28 August 2024, WHO called on mpox IVDs manufacturers to submit an expression of interest for EUL, recognizing the urgent need to bolster global testing capacities as the virus continued to spread. The EUL process assesses the quality, safety, and performance of essential health products, such as diagnostic tests, to guide procurement agencies and WHO Member States in making informed decisions for time-limited emergency procurement.

So far, WHO has received three additional submissions for EUL evaluation, and discussions are ongoing with other manufacturers of mpox IVDs to ensure a wider range of quality-assured diagnostic options. This will support countries which have not approved the medical products through their own approval processes to procure the critically needed tests through UN agencies and other procurement partners.

The EUL for Alinity m MPXV assay, allowing for its use, will remain valid as long as the PHEIC, justifying the emergency use of mpox in vitro diagnostics, is in effect.

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AIIMS Patna Vacancies: SR Post In Various Departments, Check Out All Details Here

Patna: The All India Institute of Medical Sciences, (AIIMS Patna) has announced vacancies for the post of Senior Resident (Non-Academic) on an contract basis at various departments in this medical institute.

AIIMS, Patna an Autonomous Institute of National Importance is one of the new AIIMS and apex healthcare Institutes established by the Ministry of Health & Family Welfare, Government of India under the Pradhan Mantri Swasthya Suraksha Yojna (PMSSY).

AIIMS Patna Vacancy Details:

Total No of Vacancies: 51

The Vacancies are in the Departments of Anaesthesia, Antomy, Biochemistry, Cardiology, Community Medicine, Clinical Hematology, Dermatology, ENT, Forensic Medicine, General Medicine, Neurology, Ophthalmology, Obstetrics and Gynaecology, Pathology, Physical Medicine and Rehabilitation, Paediatrics, Psychiatry, Pharmacology, Radiology, and Radiation Oncology.

The Date of Walk-In-Interview: 7th October 2024.

Reporting Time & Venue 07:30 AM at E-classroom, Administrative Building, AIIMS Patna

Time & Venue for Walk-in Interview From 09:00 AM onwards at Committee Room, Administrative Building, AIIMS Patna

For more details about Qualifications, Age, Pay Allowance, and much more, click on the given link below:
https://medicaljob.in/jobs.php?post_type=&job_tags=AIIMS+Patna&location=&job_sector=all

Eligible Candidates Note:-

FILLING UP OF APPLICATION FORM ON THE DATE OF WALK-IN INTERVIEW:

a) For filling up of application on the date of walk-in interview, the candidates have to bring the following documents (original and one set of self-attested copies) which also needs to be produced at the time of walk-in interview:-

Recent Passport size photograph of candidate

1. face clearly visible

2. The picture should be in colour, against a light-coloured, preferably white background

3. Caps, hats and dark glasses are not acceptable. Religious headwear is allowed but it must not cover your face

4. Demand Draft in original (if applicable)

5. Aadhar Card

6. Date of Birth/SSC/HSSC pass certificate (mentioning Date of Birth)

7. MBBS Degree Certificate

8. Internship Completion Certificate

9. MD/MS/DNB/DM/M.Ch Degree/Provisional Degree Certificate

10. UG & PG NMC/State Registration Certificate

11. Category/PwBD Certificate (If seat is claimed in reserved category)

12. Experience Certificate, if any

13. NOC from present employer (applicable for those working in Govt./Pvt. organization)

14. Any other relevant documents (viz. Research Work, Publication etc.)

b) The candidates are requested to fill the correct details regarding name/age/gender/caste/address/educational qualification and other relevant fields mentioned in the application form.

c) Once form is submitted, there shall be no provision for making changes in the application form.

d) Payment of application fees by any other mode viz. Cash, Cheque, Money Orders, Postal Orders, Pay Orders, Banker’s Cheques, Postal Stamps, etc., will not be accepted. Such applications will be summarily rejected. The decision of Executive Director, AIIMS Patna in this regard shall be final and binding.

Also Read:Assistant Professor Post Vacancies At Kerala Public Service Commission: Applications Open

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Brownfield Medical College Policy amended! 7 New Medical Colleges to Come Up in Gujarat

Gandhinagar: Bringing good news to the medical aspirants in Gujarat, seven new medical colleges are going up be set up in the State as the Government has amended its brownfield medical college policy.

Confirming this, the State Health Minister Rushikesh Patel recently said that with the amended policy, seven new medical colleges will be started in Botad, Devbhumi Dwarka, Gir-Somnath, Kheda-Nadiad, Chhota Udepur, Mahisagar-Lunawada, and Dang-Ahwa.

The decision in this regard was taken at a cabinet meeting held at Gandhinagar under the chairmanship of Chief Minister Bhupendrabhai Patel, Desh Gujarat has reported.

The Brownfield Medical College Policy was introduced by the State Government in 2016 to start new medical colleges at the district-level government hospitals. At present, Gujarat has seven functional brownfield medical colleges including Palanpur (Banaskantha), Amreli, Dahod, Bharuch, and Tapi-Vyara.

Also Read: UP to set up New Medical Colleges- 1 each with 100 MBBS seats in Baghpat, Hathras, Kasganj

Indian Express has reported that as per the amended policy, now the hospital will have to provide free medical treatment to pregnant woman till 20 days of delivery and children up to one year. For this purpose, the hospital has to set up a neonatal intensive care unit and a unit of 10 beds for dialysis-related services.

Further, as per the amended policy, the blood bank at the hospital will have to be continued even after the formation of a medical college and the patients will have to be provided blood as per the requirement free of cost.

The State Government will not provide any financial assistance under the new policy to the person or institute to expand the hospital in order to fulfill the requirement of a minimum of 300 beds. The hospital will have to implement all the schemes of the State and the Central Governments without getting any schematic funds.

However, the hospital shall be entitled to retain the income under the PMJAY scheme. Twenty-five percent of the gross amount of the income generated from the diagnosis fee for the treatment provided to the patients in that hospital and the PMJAY fee shall be deposited in the patient welfare committee, Desh Gujarat has reported.

Further, the hospital will have Rogi Kalyan Samiti and the institute will have to strictly implement the Gujarat Clinical Establishment (Registration and Regulation) Act, 2021 and its rules, as amended from time to time, promulgated by the State Government.

Desh Gujarat has reported that all treatments except heart, brain, cancer and organ transplant, cochlear implant shall be given free of cost in case of students referred under the school health programme. Further, the blood bank at the hospital shall be continued compulsorily even after Brown Field Medical College is established. Free blood shall be provided to all as per requirement considering the need patient’s need and priority to the nearby government institutes as per requirement without any discrimination.

After the organization take over the management of the hospital, trauma patients and vehicle accident patients will have to be compulsorily given free treatment.

Earlier this year, the former Union Health Minister Mansukh Mandaviya had shared the details regarding the availability of medical seats. As per the data, Gujarat has altogether 40 medical colleges with an intake capacity of 7150 MBBS and 2010 PG medical seats. Among these, 23 Governmenty medical colleges have 4250 MBBS seats. Further, the State also has 17 private medical colleges with an intake capacity of 2900 MBBS seats.

Also Read: 3 New Private Medical Colleges to Come Up in Gujarat, 400 MBBS seats to be added

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RG Kar doctor murder case: Junior Doctors allege being lathi-charged by police during protest

Kolkata: During a recent rally to demand justice for the deceased PG trainee doctor who was allegedly brutally raped and murdered inside the seminar room of RG Kar Medical College Hospital, the agitating junior doctors alleged that the police lathi-charged a few of them although they were protesting peacefully. 

The rally was held from the SSKM Hospital in the city’s Bhowanipore area to Dharmatala where two of their colleagues were waiting near the road. While the two doctors were waiting for the junior doctors in Dharmatala, it was alleged that the police assaulted and beat the duo doctors on the road. 

Although the exact reason is unclear, the police personnel informed PTI that the demonstration disrupted the traffic movement in the city’s heart. A video of the incident went viral on social media after BJP IT cell head Amit Malviya shared it.

Also read- ‘ Do not see any positive approach from State Government’: West Bengal Junior Doctors Resume total ‘cease work’

One of the junior doctors said “Two of our colleagues waiting near a road in Dharmatala for us were beaten up by the police. We do not know the reason. We were conducting a peaceful rally here and had permission to hold a press conference here. We protest this attitude of the policemen. Police have to apologise, else we will continue with our demonstration.”

It had earlier been expected that the medics would announce ending their ‘cease work’ which began on October 1 in a press conference in Dharmatala where their rally would culminate.

The doctors had earlier gone on a complete ‘cease work’ for 42 days following the rape and murder of a fellow medic at RG Kar Medical College and Hospital on August 9. After discussions with state officials, they ended their strike on September 21, resuming essential services. The medics, however, renewed their ‘cease work’ on October 1 after an attack on them by a patient’s family at the state-run College of Medicine & Sagore Dutta Hospital the previous week. 

“We are trying to talk to the doctors and see how the issue can be resolved,” a senior police officer told PTI when contacted.

Meanwhile, BJP IT cell head Amit Malviya shared the video on social media. In a post on ‘X’, Malviya said “The situation in West Bengal is deeply troubling. The Mamata Banerjee-led WB Police brutally assaulted peacefully protesting Junior Doctors, who were seeking justice for the deceased doctor at RG Kar Medical College & Hospital. The PGT doctors were kicked around by men, who claimed to be Police but were not in uniform.”

“The Junior Doctors have now issued a 24-hour ultimatum, for their demands to be met, failing which they will begin a hunger strike, unto death. Mamata Banerjee’s high-handedness will be held to account for any unfortunate incident that occurs during Durga Puja,” he added.

Junior docs call off ‘total cease work’

The agitating junior doctors on Friday evening called off their ‘total cease work’ at state-run medical colleges and hospitals but threatened to launch a hunger strike till death if their demands were not met by the West Bengal government within 24 hours.

“We are calling off our ‘total cease work’ and returning to duties. But we will continue our sit-in protest. We will give the state administration 24 hours to fulfil our demands or else we will start a hunger strike till death,” an agitating doctor, Debasish Halder of Kolkata Medical College and Hospital told PTI.

Braving the incessant drizzle, junior doctors holding one big clock in their hands reiterated their demands including the directive to form a central inquiry committee for disciplinary proceedings against alleged perpetrators involved in “threat culture” in all medical colleges of West Bengal, among others.

Also read- Kolkata doctor rape-murder case: Junior doctors continue cease work

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Delhi Doc murder case: Two teenagers apprehended, were allegedly hired by a nurse’s husband

New Delhi: So far the Delhi police have arrested two teenagers in connection with the murder of a Delhi-based doctor inside Nima Hospital in the Jaitpur area and are searching for a third suspect in the case, who also appears to be a minor.

The two teenagers have been identified as one 15-year-old from Hapur in Uttar Pradesh and another 16-year-old boy. According to the police, the 16-year-old boy is the main accused in the case whereas the motive behind the crime of the 15-year-old teen is yet to be ascertained. Suspecting the involvement of a third teenager, the police are investigating his whereabouts after confirming his identity. 

The main accused was arrested after he confessed that he shot Dr Javed Akhtar on the instructions of the husband of a nurse working in the same hospital. Following this, the police questioned the female nurse and her husband in connection.

Also read- Breaking News: Doctor Shot Dead in Delhi Hospital

However, the police managed to apprehend the main accused after he allegedly uploaded a photo with a pistol on Instagram with a caption saying “Kar diya 2024 mein murder” (Finally committed murder in 2024).” 

Medical Dialogues had reported this incident where these two teenagers came to the hospital with an injury. After receiving the first-aid treatment and dressing from the hospital, they allegedly demanded to meet the doctor. Once they entered the doctor’s cabin, they shot him dead. 

According to the police, he was found in a chair oozing blood from the head inside the nursing home. He is survived by his wife, who is also a Unani practitioner, and two children. The family resided in Shaheen Bagh.

As per PTI news agency report, an employee at the nursing home said Akhtar had been working there for the past two years. On the day of the incident, his duty began at 8 pm on Wednesday. The nursing staff who were on night duty, heard the gunshot. They rushed inside the cabin and found Akhtar sitting still in a pool of blood.

Speaking to Indian Express, a Delhi police officer said “The accused is claiming that the husband suspected an affair between the nurse and Dr Akhtar. The accused teen said he was in love with the nurse’s daughter. So, the husband promised he would get his daughter married to him if he killed Dr Akhtar. He is changing his statements about the motive. The claims are being verified.”

Joint Commissioner of Police (Southern Range) S K Jain told PTI that the murder was a targeted killing executed by two boys living in the same locality. He further said the duo met a compounder for dressing and later shot the Unani practitioner in his cabin. The 16-year-old apprehended juvenile is the one who allegedly opened fire at the doctor. His act was also captured in a CCTV camera installed in the nursing home, he added. 

The officer said six teams were formed and CCTV footage was collected from inside and around the nursing home. The teams of the crime branch also helped in nabbing the main accused.

Also read- GTB Hospital Shocker: Patient shot dead, Doctors fear for security

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Medical Bulletin 05/ October/ 2024

Here are the top medical news for the day:

Does Severe Climate Change Increase Violence Against women? PLOS Climate Study Highlights

Countries affected by severe climate change may also have a higher prevalence of violence against women, finds a new study led by UCL researchers.
The research, published in PLOS Climate, examined how climate shocks – such as storms, landslides and floods – might be linked to higher rates of intimate partner violence in the two years following the event.
The researchers gathered data on intimate partner violence from 363 surveys conducted in 156 countries between 1993 and 2019, focusing on women who currently had a partner. Intimate partner violence was defined as any physical and/or sexual violence in the past year. The team also gathered data on climate shocks from 1920 to 2022 in 190 countries. They then analysed the relationship between climate shocks and intimate partner violence, while also considering the country’s economic status.
They found that there was a significant link between intimate partner violence and certain climate shocks (including storms, landslides and floods). Meanwhile, other types of climate shocks (such as earthquakes and wildfires) didn’t show a clear connection to intimate partner violence. Countries with higher GDP had lower rates of intimate partner violence.
Lead author, Professor Jenevieve Mannell (UCL Institute for Global Health), said: “Existing evidence has found that when a woman experiences a climate-related event, she is more likely to experience violence in some countries and for some types of violence, but not others. “We set out to explore what was happening at a national level to help inform international climate change policy.”
The researchers were unable to assess why different climate shocks have more of an impact on intimate partner violence. However, they believe that different shocks may take different amounts of time to have an effect on violence and this may not have been captured in the two-year window studied, due to data availability. As a result, they are calling for more regular data collection by countries on measures of violence against women.
Professor Mannell added: “A small body of evidence shows that heat and humidity increases aggressive behaviours, including violence. Climate-related disasters increase stress and food insecurity in families in ways that can lead to increases in violence. They also reduce the social services often available for dealing with partner violence, such as police and civil society who are more focused on the disaster.
“At the same time, governments may put in place shelters for disaster relief which are often overcrowded and unsafe, without thinking about the risks of sexual violence.“All of this happens more often and with increased severity in countries that have patriarchal gender norms and where the use of violence against women is widely accepted as normal behaviour.”
Importantly, the researchers believe that climate mitigation and adaptation efforts can and should play an important role in reducing violence against women.
Reference: Mannell, J., Brown, L. J., Jordaan, E., Hatcher, A., & Gibbs, A. The Impact of Climate Shocks Due to Climate Change on Intimate Partner Violence: A Structural Equation Model of Data from 156 Countries. Available at SSRN 4800400.
Exposure to Common Consumer Product Chemicals May Be Linked to Cardiac Electrical Changes
Environmental phenols are found in a wide range of common consumer products. They include preservatives in packaged foods, parabens in shampoos and bisphenol A (BPA) in plastic dishware, so humans have broad exposure to them, day in and day out.
Some of these environmental phenols are known to have cardiac toxicities. Now, an interdisciplinary study involving four University of Cincinnati College of Medicine professors is revealing their adverse impact on the heart’s electrical properties, and the research has been published in the journal Environmental Health.
Researchers used data from the Fernald Community Cohort, which includes nearly 10,000 people who lived near the former U.S. Department of Energy uranium processing site at Fernald, outside Cincinnati, and participated in the Fernald Medical Monitoring Program between 1990 and 2008.
Much of the cohort did not experience exposure to uranium beyond the radiation received by the general population. Researchers used their data, including biological samples and medical records, in the study so uranium exposure would not be a factor in the findings — making them relevant to the general population. Because urine samples and electrocardiograms, or EKGs, were collected on the same day, the results were significant for analyzing exposure to environmental phenols.
The EKGs, which measure cardiac electrical activities, were read by board-certified physicians, and the urine samples were sent to the Centers for Disease Control and Prevention for exposure analysis.
One goal of the study was to identify any changes in EKG parameters associated with environmental phenol exposure.
The heart is driven by electrical activity, so anything affecting its electrical properties can have a detrimental impact and possibly result in arrhythmias.
The research concluded higher exposure to some environmental phenols is associated with altered cardiac electrical activity.
Researchers found higher exposure to BPA, BPF and BPA+F in women is associated with a longer PR interval, a delay in the time it takes for electrical signals to move from the atria at the top of the heart to the ventricles.
“Our findings were highly sex-specific,” said Hong-Sheng Wang, PhD, professor in the Department of Pharmacology, Physiology and Neurobiology and the study’s lead author.
In women, researchers identified an association with longer QRS duration, or contraction of the ventricles, and dysfunction of the electrical impulses of the heart.
“It was particularly pronounced in women with higher body mass indexes,” said Wang.
In men, researchers found higher exposure to triclocarban (TCC), an antimicrobial agent, led to longer QT intervals in the heart — meaning the heart’s electrical system is taking too long to recharge, a situation that can contribute to heart rhythm dysfunction. TCC has since been banned in the United States.
Wang also pointed out that typical exposure levels alone are unlikely to cause clinically significant heart disease in healthy people.
Reference: Rubinstein, J., Pinney, S. M., Xie, C., & Wang, H. S. (2024). Association of same-day urinary phenol levels and cardiac electrical alterations: analysis of the Fernald Community Cohort.
Nature Medicine Study Highlights Impact of Doxycycline-Post Exposure Prophylaxis for STI on Gut Microbiome
Taking a dose of the oral antibiotic doxycycline after a high-risk sexual encounter has dramatically reduced the incidence of sexually transmitted infections (STIs) in places where the strategy is being tried.
Despite its effectiveness, the new strategy, known as Doxycycline post-exposure prophylaxis, may come with risks, especially with chronic use. Experts worry about the impact on the community of gut bacteria, also known as the microbiome, and the potential that the antibiotic will give rise to resistant strains of bacteria. 
Doxycycline post-exposure prophylaxis did not have much impact on the overall composition of bacterial communities in gastrointestinal tracts. But scientists noted signs of resistance building against tetracycline, the class of antibiotic that doxycycline belongs to, which could make it less effective. 
The study was published in Nature Medicine.
“While doxycycline post-exposure prophylaxis did not appear to have global impacts on the gut microbiome, it did have impacts on the antimicrobial resistance of gut bacteria, both in terms of the proportion of tetracycline class resistance genes and the amount that were turned on, or expressed,” said Chaz Langelier, MD, PhD, an associate professor of medicine in UCSF’s Division of Infectious Diseases and senior author of the paper. “So, it’s not totally innocuous.”    
Doxycycline post-exposure prophylaxis involves taking two 100-milligram pills within 72 hours of condomless sex.
But the widespread use of antibiotics raises concerns about resistance and the potential harmful impact on gut health, specifically the balance of bacteria and other microbes. Disruption can lead to diarrhea, nausea, fever and abdominal pain; and until now, there had been very limited research into these side effects. 
The study included 100 individuals who used doxycycline post-exposure prophylaxis and 50 individuals who received standard-of-care and did not use doxycycline post-exposure prophylaxis. Researchers analyzed rectal swabs collected at enrollment and after six months to study the presence of DNA and RNA from gut bacteria and their antibiotic resistance genes.
“While we found no major changes to the community of gut bacteria in doxycycline post-exposure prophylaxis users, we saw that doxycycline post-exposure prophylaxis users over time had increasing amounts of tetracycline resistance genes present in their gut,” said Victoria T. Chu, MD, MPH, an assistant professor of pediatrics in the Division of Global Health and Infectious Diseases at UCSF and a first author of the study. “It also appeared to be dose dependent, meaning the more doxycycline post-exposure prophylaxis they used, the larger the increase was.” 
Reference: Chu, V.T., Glascock, A., Donnell, D. et al. Impact of doxycycline post-exposure prophylaxis for sexually transmitted infections on the gut microbiome and antimicrobial resistome. Nat Med (2024). https://doi.org/10.1038/s41591-024-03274-2
Novel Imaging Technique Detects Aggressive Kidney Cancer with Unprecedented Accuracy: Lancet Oncology
A new study led by investigators from the UCLA Health Jonsson Comprehensive Cancer Center has demonstrated a new, non-invasive imaging technique that may accurately detect clear-cell renal cell carcinoma, the most common form of kidney cancer.
The findings, published in The Lancet Oncology, could greatly reduce the number of unnecessary surgeries and ensure that patients receive the right treatment at the right time, potentially changing how doctors diagnose and treat the disease in the future.
“If kidney cancer is diagnosed late, the chances of survival drop significantly, especially if the cancer has spread,” said Dr. Brian Shuch, director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA, and lead author of the study. “But if caught early, over 90% of patients can survive for at least five years. If we are going to survey more tumors, it’s crucial to accurately identify clear-cell renal cell carcinoma early on as they have a greater propensity to grow and spread.”
To help improve the detection of clear-cell renal cell carcinoma, the team tested a non-invasive method that uses a monoclonal antibody drug called 89Zr-TLX250, which targets the protein CA9 that is often found in clear-cell renal cell carcinoma.
The phase 3 trial, called ZIRCON, included 332 patients with suspect lesions detected on their kidney from 36 research hospitals from nine different countries with UCLA leading international accrual. The average age of participants was 61 years, with 71% being male and 29% female.
The patients were injected with 89Zr-TLX250, which travels through the body and attaches to the protein CA9 if present in the kidney mass. CA9 is highly expressed in up to 95% of clear cell kidney cancers with minimal expression in normal tissue.
A few days after the injection, patients received a PET-CT scan to detect the radioactive part of the drug, which lights up on the scan wherever the protein is present, allowing doctors to see the cancer more clearly. By looking at the scan, doctors can determine if the kidney mass is likely to be cancerous based on whether or not the 89Zr-TLX250 has attached to the cancer cells.
The new imaging method accurately identified the presence of cancer in most cases while minimizing false positives, demonstrating a high performance with 85.5% sensitivity and 87.0% specificity.
The technique also proved effective even in very small renal masses (less than 2 cm), which are increasingly detected due to more frequent use of abdominal imaging. Additionally, the procedure was shown to be safe, with no significant side effects associated with the use of 89Zr-TLX250.
“The implications of this research are vast,” said Shuch. “If adopted widely, 89Zr-TLX250 PET-CT imaging could become a new standard in kidney cancer diagnostics, like how PET-CT imaging has revolutionized prostate cancer management. It could also aid in the detection of other types of kidney cancers and help monitor patients at high risk of metastasis.”
Reference: [89Zr]Zr-girentuximab for PET–CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial. Shuch, Brian et al. The Lancet Oncology, Volume 25, Issue 10, 1277 – 1287
Researchers Shed Light on Novel Superfast Blood Draw Technique for Diagnosing Lung Cancer
A new way of diagnosing lung cancer with a blood draw may be 10 times faster and 14 times more sensitive than earlier methods, according to University of Michigan researchers.
The microchip developed at U-M captures exosomes—tiny packages released by cells—from blood plasma to identify signs of lung cancer. Although healthy cell exosomes move important signals throughout the body, cancer cell exosomes can help tumors spread by preparing tissues to accept tumor cells before they arrive. “Cancer exosomes leaving the tumor microenvironment go out and kind of prepare the soil. Later, the cancer cell seeds shed from the tumor and travel through the bloodstream to plant in the conditioned soil and start to grow,” said Sunitha Nagrath, U-M professor of chemical and biomedical engineering and co-corresponding author of the study in the journal Matter. Exosomes carry proteins both inside the parcel and on their outside surface. Like many biological molecules, these surface proteins are chiral—meaning they have a right- or left-handed twist—which causes them to interact with light in unique ways.
In cancer exosomes, surface proteins are often mutated, meaning a genetic change altered the order of the molecules that make up the protein. Mutations subtly change the shape of the protein, which also shifts its chirality. These differences can be spotted through interactions with twisted—or circularly polarized—light, which can match the twist in the protein. The resonance creates a strong signal returned to a light detector. However, these light signatures are typically weak and hard to interpret. Furthermore, exosomes must be extracted from a blood sample to do this kind of detection. This is tricky because exosomes are small—measuring just 30 to 200 nanometers (a millionth of a millimeter).
To spot them, the research team designed gold nanoparticles shaped like twisted disks (adapted from a structure first described in a 2022 Nature study) that capture exosomes in a central cavity. Because of a nearly perfect match in size, shape and surface chemistry, these cavities reliably catch exosomes.
With a right-handed twist, they resonate strongly with right-twisting light but don’t send back much signal if the incoming light has a left-handed twist. This different response to twisted light is known as circular dichroism. The proteins on the captured exosomes, sunk into the cavity, can strengthen or reduce the intensity of the return signal depending on their shapes. Studded along the tiny channels of a microfluidic chip, the gold cavities captured exosomes from blood plasma and revealed distinct signatures between samples given by healthy study participants and those with lung cancer. The microfluidic chips, named CDEXO chips for Circular Dichroism detection of EXOsomes, may be able to distinguish among specific lung cancer mutations, helping doctors make treatment decisions to target the dominant mutations as they change.
Reference: Kang, Y. T., Kim, J. Y., Turali-Emre, E. S., Kumari, A., Jang, H. J., Cha, M., … & Kotov, N. A. (2024). Chiroptical detection and mutation analysis of cancer-associated extracellular vesicles using microfluidics with oriented chiral nanoparticles. Matter.
Overweight Pregnancies Have Higher Risk of Complications Than Underweight Pregnancies: Lancet Study Highlights
The risk of complications during pregnancy is particularly high in women born in certain parts of the world. It is not clear why, but many different factors that affect health can contribute to this inequality. One possible factor is body weight. It is more common among migrant women from certain regions to have underweight, overweight or when they become pregnant.
What is new about this study is that the researchers have been able to estimate to what extent the complications, such as gestational diabetes, could be avoided if all women were of normal weight when they became pregnant.
“For example, we concluded that about half of all cases of gestational diabetes could potentially be prevented. This applies to both women born in Sweden and foreign-born women,” says Maryam Shirvanifar, PhD student at Linköping University and first author of the study.
The researchers believe that efforts to promote a healthy weight could help all women, no matter where in the world they were born.
The study paints a complex picture. The importance of body weight differs between different complications. For example, high body weight contributes more to gestational diabetes than other complications.
But what about being underweight in early pregnancy, how does this affect the risks? To the surprise of the researchers, underweight does not seem to contribute significantly to the complications investigated.
In their study, the researchers followed almost two million pregnancies – basically all births in Sweden from 2000 to 2020. The researchers studied eight complications that can affect the mother or baby during pregnancy, or during and after childbirth. Using data from several national registers, they were able to investigate the relationship between a woman’s BMI at the first antenatal visit and complications depending on which region of the world the mother was born in.
In their analyses, the researchers took into account several factors, including socio-economic data. However, some factors that could affect a woman’s health during pregnancy and childbirth, such as quality of treatment in healthcare, communication barriers, stress linked to migration and differences in health-promoting behaviour, could not be investigated in the current study as it uses register data.
In their study, the researchers examined eight different complications in the mother and baby:
– severe complication in the mother that could be fatal
– preeclampsia
– gestational diabetes
– infant mortality in the first year of life
– preterm birth (before 37 weeks of pregnancy) and extremely preterm birth (before 28 weeks of pregnancy)
– low Apgar score (assessment of newborn baby’s vitality)
– large baby (in relation to length of pregnancy)
– small baby (in relation to length of pregnancy)
Reference: Adverse pregnancy outcomes attributable to overweight and obesity across maternal birth regions: a Swedish population-based cohort study Shirvanifar, Maryam et al. the Lancet Public Health, Volume 9, Issue 10, e776 – e786

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Astrazeneca Calquence granted priority review by USFDA for previously untreated mantle cell lymphoma

Cambridge: AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2025.

MCL is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL), resulting when B-lymphocytes mutate into malignant cells within a region of the lymph node known as the mantle zone. The disease is often diagnosed at advanced stages and remains largely incurable. It is estimated that there are more than 27,500 people living with MCL worldwide.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, “The Priority Review acceptance reinforces the potential of Calquence to transform outcomes in untreated mantle cell lymphoma. Data from the ECHO trial showed Calquence plus chemoimmunotherapy significantly delayed disease progression and showed a trend to improved survival in patients with this currently incurable blood cancer. We are working closely with the FDA to provide patients this potential new treatment as soon as possible.”

The sNDA is being reviewed under Project Orbis, an initiative of the FDA which provides a framework for concurrent submission and review of oncology medicines among participating international partners to bring cancer treatments to patients around the world as early as possible.

Results from the ECHO Phase III trial recently were presented during the late-breaking oral session at the European Hematology Association (EHA) 2024 Hybrid Congress.

In the trial, Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care (SoC) chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). The addition of Calquence to SoC provided almost 1.5 years of additional median progression free survival (mPFS) with mPFS of 66.4 months for patients treated with the Calquence combination versus 49.6 months with SoC.

Overall survival (OS) showed a favourable trend for the Calquence combination compared to SoC chemoimmunotherapy (HR 0.86; 95% CI 0.65-1.13; p=0.2743). The OS trend was sustained over time, although most patients in the SoC arm who needed subsequent therapy received a BTK inhibitor, mainly Calquence. The OS data were not mature at the time of this analysis, and the trial will continue to assess OS as a key secondary endpoint.

The ECHO trial was conducted during the COVID-19 pandemic, and prespecified PFS and OS analyses censoring for COVID-19 deaths were conducted to assess the impact of COVID-19 on the study outcome in alignment with FDA. After censoring for COVID-19 deaths, the PFS was further improved in both arms, with the Calquence combination reducing the risk of disease progression or death by 36% (HR 0.64; 95% CI; 0.48-0.84; p=0.0017). A favourable trend was seen for OS in this analysis for the Calquence combination, but OS data were not mature at the time of this analysis (HR 0.75; 95% CI 0.53-1.04; p=0.0797).

The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified.

Read also: USFDA grants priority review to AstraZeneca-Daiichi Sankyo Enhertu for HER2-low, HER2 Ultralow Breast Cancer

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NEET Counselling 2024: 10 Medical colleges get LoP from Health Ministry, MCC Adds 150 MBBS seats for Round 3

New Delhi- Through a notice, the Medical Counselling Committee (MCC) has informed that certain colleges have been approved with a fresh permission letter (LOP) for MBBS seats from the Ministry of Health & Family Welfare. With this, new seats of these colleges will be included in the seat matrix for National Eligibility and Entrance Test-Undergraduate (NEET UG) Round 3 counselling 2024 for MBBS admissions.

As per the notice, it has been informed that the MCC of DGHS has received information that the 10 colleges have been approved with a fresh permission letter (LOP) from the Ministry of Health & Family Welfare (ME-I) and a total of 150 seats of the colleges will be included in the seat matrix for Round-3 of UG Counselling 2024 in the larger interest of the candidates.

Candidates will be able to opt for the newly added seats in Round 3 of UG Counselling 2024 as per the list given below-

S.NO

INSTITUTE

TOTAL SEAT (AIQ)

1

Government Medical College, Buldhana, District Women Hospital, T.B. Hospital Campus, Dhad Road, Buldhana., Maharashtra, 443001

15

2

Government Medical College, Ambernath, Dr B. G. Chhaya Sub District Hospital, Ambernath Municipality, Shiv Market, Ambernath, Maharashtra 4, Maharashtra, 421501

15

3

Government Medical College, Hingoli, Government Medical College, Washim Road, Balsond, Hingoli, Maharashtra, 431513.

15

4

Government Medical College, Bhandara, District Hospital Campus, Sant Kabir Ward, Bhandara, Maharashtra, 441904.

15

5

Government Medical College, Amravati, Government Medical College District Women Hospital Campus Daffrin Shrikrishna Peth Amravati, Maharashtra, 444601.

15

6

Government Medical College, Washim, Government Medical College, Washim District Women’s Hospital building, Nalanda Nagar, Chikhali Road, Maharashtra, 444505.

15

7

Autonomous State Medical College, Sonebhadra, Rounp Rd, Churk, Robertsganj, Sonebhadra, Uttar Pradesh, 231216.

15

8

Government Medical College, Gadchiroli, Government Medical College, Mul road complex, Gadchiroli, Maharashtra, 442605.

15

9

Government Medical College, Jalna, Government Medical College Global Gurukul School Opp Sushiladevi Lawns Ambad Mantha Road Jalna 43121, Maharashtra, 431213.

15

10

Government Medical College, Haridwar, Jagjeetpur Laksar Road Haridwar, Uttarakhand, 249408.

15

TOTAL

150

To view the notice, click the link below

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USFDA nod to Perioperative treatment of Neoadjuvant Opdivo, Chemotherapy followed by Surgery, Adjuvant Single Agent Opdivo for Resectable Non Small Cell Lung Cancer

Princeton: Bristol Myers Squibb has announced that the U.S.  Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery – otherwise referred to as perioperative therapy, which is used before and after surgery.

 The approval is based on results from the CheckMate-77T trial, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC.  Opdivo is now the only PD-1 inhibitor to demonstrate statistically significant and clinically meaningful benefits in this disease versus chemotherapy in both a neoadjuvant-only regimen and as part of a perioperative regimen. 

“Given the rates of disease recurrence in patients with resectable NSCLC, there is a clear need for options that can be administered before and after surgery that may target micrometastasis, help reduce the risk of cancer returning and improve the chance of successful surgical treatment,” said Tina Cascone, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. “This approval is a step forward for patients with resectable disease, as the perioperative nivolumab plus neoadjuvant chemotherapy regimen can offer an improved event free survival (EFS) compared with neoadjuvant chemotherapy alone and has the potential for achieving a pathologic response (pCR) in one in four patients.” 2

The CheckMate-77T trial evaluated the perioperative regimen of neoadjuvant Opdivo with platinum-doublet chemotherapy followed by surgery and adjuvant Opdivo monotherapy (n=229), compared to neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo (n=232) in adult patients with resectable NSCLC.  In the trial, the Opdivo arm improved EFS, a primary endpoint, compared to the chemotherapy and placebo treatment arm. A high pCR rate was also observed as one of the pre-specified secondary endpoints. 

The risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 0.43 to 0.78; P =0.00025) in patients treated in the Opdivo arm, compared to the chemotherapy and placebo arm, with a median follow-up of 25.4 months. 2 In addition, 18-month EFS was demonstrated in 70% of patients in the Opdivo arm, compared to 50% of patients in the chemotherapy and placebo arm. Furthermore, 25% of patients in the Opdivo arm achieved pCR, while 4.7% of patients in the comparator arm achieved pCR in the intent-to-treat population (estimated treatment difference of 20.5%; 95% CI,14.3 to 26.6). 

Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis and renal dysfunction; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue and dexamethasone is not recommended outside of controlled clinical trials. 

“This milestone expands the role of Opdivo -based treatments and builds upon the foundation set by the FDA approval of neoadjuvant-only Opdivo plus chemotherapy in resectable NSCLC based on the CheckMate-816 trial,” said Wendy Short Bartie, senior vice president of U.S. Oncology and Hematology at Bristol Myers Squibb. 1 “With this new Opdivo -based regimen, we are reinforcing our commitment to helping improve patient outcomes and expanding our thoracic portfolio in early-stage disease.”

The recommended dose for Opdivo in this indication is 360 mg with platinum-doublet chemotherapy on the same day every three weeks for up to four cycles or until disease progression or unacceptable toxicity, then continued as a single-agent Opdivo 480 mg every four weeks after surgery for up to 13 cycles (approximately one year) or until disease recurrence or unacceptable toxicity. The FDA previously approved Opdivo for adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. Opdivo and Opdivo -based combinations have been approved by the FDA in the neoadjuvant, adjuvant or perioperative settings across four cancers to date, including lung cancer, melanoma, bladder cancer and esophageal/gastroesophageal junction cancer.  

Read also:USFDA approves Bristol Myers Squibb Cobenfy for Schizophrenia treatment in adults

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MCC notifies on resignation process for Round 1, 2 NEET 2024 allotted Candidates

New Delhi- The Medical Counselling Committee (MCC) has informed all the candidates through a notice that those who want to resign from their National Eligibility and Entrance Test-Undergraduate (NEET UG) Round-1 or Round-2 Counselling 2024 seats due to various reasons can do so.

As per the notice, MCC has informed that the authority has received requests from the UG candidates who want to resign their Round-1 or Round-2 seats. In this regard, the competent authority has decided to allow Resignation for such candidates. The candidates who desire to leave their Round-1 or Round-2 seat can do so till 06:00 P.M of 06 October 2024.

The candidates should take note of the following instructions w.r.t Resignation-

1 Round-1 candidates who did not get upgraded in Round-2, can resign from their seat without forfeiture of the security deposit within the stipulated time of resignation.

2 Freshly allotted candidates of Round-2 who joined their seat but now want to resign can vacate their seat with forfeiture of security deposit within the stipulated time of resignation.

3 Candidates who got upgraded in Round-2, joined the upgraded seat but now want to resign from their seat can vacate their seat with forfeiture of security deposit within the stipulated time of resignation.

4 Candidates will have to report physically at the allotted college to resign their seats.

5 Candidates are advised to ensure that their Resignation Letter is generated online (through the portal provided by MCC) by the allotted college, failing which the resignation will be treated as ‘Null & Void’.

The Medical Counselling Committee (MCC) is an organisation under the Directorate General of Health Services (DGHS) affiliated to the Ministry of Health and Family Welfare, Government of India and responsible for allotting seats for undergraduate, postgraduate and super-speciality medical and dental courses in government-run/aided colleges and deemed-to-be-university colleges. 

To view the notice, click the link below

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