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After mpox outbreak, Africa is under the threat of yet another virus outbreak, this is the Marburg virus outbreak in Rwanda. So far, six people have died from the outbreak, confirmed the health minister. Most victims were the healthcare workers in the hospital's intensive care unit. As per reports, 20 cases have been identified since the outbreak was confirmed on Friday.
With the fatality rate of 8% it is the same virus family as Ebola. The main carrier is from fruit bats which spreads to humans then through the contact of bodily fluids of infected individuals, it spreads to others.
The common signs and symptoms of the Marburg virus include fever, pain, diarrhoea, vomiting and in the case of extreme blood loss, death too can happen.
So far, there is no specific treatment or vaccine for the virus. However, treatments like drugs and immune therapy are being developed as per the World Health Organisation (WHO).
Rwanda says that it has intensified its contact tracing, surveillance and testing to contain the spread. It has also tracked about 300 people who had come into contact with individuals affected by the Marburg virus.
The health minister has urged people to stay vigilant and avoid any physical contact and to wash their hands with clean water, soap or sanitiser and report any suspected case.
As of now, most of the cases have spread to the capital in Kigali. In light of this, the US Embassy in the city has advised its employees to work remotely for the next week.
This is the first time Rwanda has confirmed for Marburg cases, before this, in 2023, Tanzania confirmed the outbreak, whereas three people had died of this in Uganda in 2017.
As per WHO, this virus kills half of the people it infects. In the previous outbreaks, it has killed between 24% to 88% of the patients.
The virus was first detected in 1976 after 31 people were infected, out of which 7 died in simultaneous outbreak in Marburg and Frankfurt in Germany, and Belgrade in Serbia.
The source was traced to African green monkeys who were imported from Uganda. However, other animals too are linked to the virus spread, including bats.
In the past, the virus outbreaks have happened in countries like Equatorial Guinea, Ghana, the Democratic Republic of the Congo, Kenya, South Africa, Uganda, and Zimbabwe. In 2005, this virus killed 300 people in Angola.
However, for the rest of the world, only two people have died from the virus in the rest of the world, with one of them being in Europe, and the other in the US. These both have been on expeditions to caves in Uganda.
Credit: AI
The US Food and Drug Administration (FDA) has a step towards reducing animal use in drug research, focusing on technologies like human organoids, organs-on-chips, artificial intelligence and computer modelling that may play a bigger role in deciding whether medicines are safe before they are tested in people.
The move is part of the US Department of Health and Human Services's initiative declared on September 21 to shift biomedical research towards methods that reflect human biology more closely.
As part of the changes, the FDA issued a rule updating its regulations to state that non-animal methods can be used where it is appropriate to assess the safety of drugs before human trials.
“This new rule supports the Trump Administration’s push to explore ways to complement, or where appropriate, replace animal studies with methods that may better predict how medicines will actually affect people,” FDA Acting Commissioner Kyle Diamantas said.
“Our goal is not to replace one rigid approach with another. It is to support rigorous, modern science — including animal studies when they remain appropriate and validated alternatives when they can provide the evidence needed to protect patients,” he added.
Animal testing has always been a central part of drug development for decades. But a drug behaving safely in an animal does not necessarily mean it will behave the same way in humans. This is partly because species differ in their biology, metabolism and immune responses.
The FDA's new approach is built around New Approach Methodologies (NAMs), a term for covering laboratory and computational methods that can provide more accurate evidence without relying entirely on animals.
The agency has already issued guidance on how developers can use and validate these methods. It has also created a database containing examples of NAMs used in FDA reviews.
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Organoids are three-dimensional clusters of cells grown from human stem cells. They can replicate the structure and some of the function of organs.
Researchers can grow models resembling parts of the liver, intestine, brain, kidney or other tissues and use them to test experimental medicines. This can allow scientists to study how human cells respond directly to a drug, including side effects.
The HHS initiative includes plans for the NIH Clinical Center to develop a laboratory combining standardised human organoids with robotics, AI and advanced data systems.
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Organs-on-chips, also called microphysiological systems, are small devices containing human cells that mimic aspects of an organ's structure and environment. Researchers can expose these cells to drugs and observe their responses in a controlled environment.
For example, a liver-on-a-chip can help researchers investigate whether a drug damages liver cells, while other systems can model the interaction between different tissues.
The FDA says newer approaches include human cells, organs-on-chips and computer models, provided they are appropriately suitable scientifically.
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AI and computational models can analyse huge amounts of biological and drug data to predict how a medicine may behave in the human body.
HHS' Advanced Research Projects Agency for Health is investing in computational approaches designed to assess drug safety and reduce dependence on animal experiments.
The FDA's rule, however, does not prohibit animal studies. Instead, it does away with language that imply animal testing is the only acceptable way to test drugs and biomedical products.
Non-animal studues can be used when they are scientifically appropriate for the particular drug and regulatory requirements.
Credit: AI
Low levels of vitamin D during pregnancy could be linked with a higher risk of preterm birth. The strongest link were seen among women who delivered very prematurely, according to a recent study.
Researchers from the Medical University of South Carolina studied health data from 15,506 pregnancies in which the vitamin D levels of expectant mothers measured during pregnancy.
The study, published in the Journal of Perinatology, found that women with lower levels of 25-hydroxyvitamin D, the main blood marker used to assess vitamin D status, were more likely to deliver before 37 weeks.
The association was even more pronounced among women who delivered before 32 weeks, a group which is considered very preterm.
Of the 15,506 deliveries, 13,451 were at term, while 1,652 were moderately preterm and 385 occurred before 32 weeks. The researchers found that women who delivered preterm had lower average vitamin D concentrations than those who delivered at term. The lowest vitamin D levels were seen among women who delivered before 32 weeks.
Nearly 45% of women had a vitamin D level below 30 ng/mL at some point during pregnancy, while about 66% had levels below 40 ng/mL.
The researchers adjusted their analysis for maternal age, race and ethnicity and insurance status, and the association between higher vitamin D levels and lower odds of preterm birth remained same.
But, this was a retrospective observational study, meaning it can identify an association but cannot prove that low vitamin D itself caused an early delivery. Other factors that influence both vitamin D levels and pregnancy outcomes may also play a role.
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Vitamin D is best known for its role in calcium absorption and bone health, but it also plays a role in immune function, placental development and other processes involved in pregnancy.
Researchers say several biological mechanisms could potentially explain the association with preterm birth, including effects on inflammatory pathways, placental function and fetal growth.
The findings also add to previous research. A 2025 NIH-funded study involving 351 first-time mothers found that women with vitamin D levels below 40 nmol/L during the first trimester had 4.35 times the risk of preterm birth compared with women whose levels were above 80 nmol/L.
Another import aspect is that the new study shows that lower vitamin D levels are associated with earlier delivery, but it does not show that raising vitamin D levels will prevent preterm birth.
A Cochrane review found the evidence for vitamin D supplements reducing preterm birth is not certain or confirmed. The NIH's current guidance notes also state that there is insufficient evidence to recommend routine vitamin D supplementation specifically to prevent preterm birth.
The researchers say randomised clinical trials are needed to determine whether optimising vitamin D levels during pregnancy can actually reduce the risk of preterm birth.
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Biotechnology company Grail's vision of detecting more than 50 cancers with one blood test may soon become a reality after it showed promise of a positive outcome with the US Food and Drug Administration staff reviewers.
According to Reuters, FDA has not raised any major concerns yet about the accuracy and of the blood test, Galleri, which is designed to capture signals from more than 50 types of cancer. The promising biomedical technology seems to be closer to a positive regulatory decision.
Ahead of an advisory committee meeting on September 23, FDA briefing documents were released which said that reviewers had no outstanding questions regarding its accuracy, safety, overall analytical performance, and study design.
However, this does not mean the FDA has approved Galleri. External advisers will now examine whether the available evidence is sufficient to back it and approve the multi-cancer early detection test.
Galleri is a type of multi-cancer early detection (MCED) test. Instead of searching for one specific cancer, it examines and analyses DNA fragments circulating in the blood for chemical patterns linked with various cancers.
If the test detects a cancer signal, it also attempts to predict where in the body that signal originated, helping doctors decide which diagnostic tests may be needed next.
The test is not meant to replace to existing cancer screening tests such as mammograms, colon cancer screening and cervical cancer screening. It is supposed to be used with existing screening methods for faster and more accurate diagnoses.
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No multi-cancer detection test is currently FDA-authorised in the US. Some are available as laboratory-developed tests, but they do not undergo the same premarket approval process.
Grail submitted Galleri for FDA premarket approval in January 2026. The application includes data from PATHFINDER 2, a US study involving more than 25,000 participants, as well as data from the large NHS-Galleri trial in the UK.
The FDA's latest briefing documents describe the test as having a favourable benefit-risk profile, but advisers have been asked to consider an important question before making their decision.
The question is does detecting a cancer signal translate into meaningful clinical benefit for patients? It's important as finding more cancers is not automatically the same as saving more lives.
In February, Grail reported that its large UK NHS-Galleri trial did not significantly reduce the combined rate of stage III and IV cancers, the study's primary endpoint, across three screening rounds.
Later analyses reported by Grail found reductions in stage IV diagnoses during screening rounds that were held later, but the company also acknowledged that the trial did not show a statistically significant reduction in the combined primary endpoint of stage III and IV cancers.
This is why the FDA's question about whether Galleri should be considered an “early detection” test is particularly crucial.
The FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to review the application on September 23. The panel's recommendation will help inform the FDA. If authorised, Galleri could become the first FDA-authorised multi-cancer detection test in the US.
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