FDA cautions variants could produce false negatives in approved COVID-19 tests

The FDA is warning health care professionals to be on the lookout for false negative test results triggered by COVID-19 variants, such as the variant identified in the U.K. The FDA believes the following three currently authorized tests may potentially be compromised by genetics variants: Thermo Fisher's TaqPath combo kit, Mesa Biotech's hand-held Accula test, and Applied DNA Sciences' Linea assay. All FDA-approved COVID-19 tests, totaling more than 200, are now being reevaluated.

When alterations occur in the location of the coronavirus' RNA used by molecular diagnostics to produce a positive result, the Agency says test accuracy can be affected. This utility can vary from product to product. According to the FDA, the most accurate test results come from tests that use several areas of the coronavirus genome to establish a positive match.

Interestingly, the TagPath and Linea test detection patterns may also help identify new strains of the virus, says the FDA.

Sinopharm claims COVID-19 vaccine is safe in children

Sinopharm subsidiary China National Biotec Group (CNBG) says a clinical trial has found its COVID-19 vaccine to be safe in children ages 3 to 17 years old. Study details were shared in an article released by Xinhua, China's official state-run press agency.

More details on the significance of the CNBG clinical trial could emerge if the data is shared on an international scale. No side effect profile for the tested vaccine has yet been published.

Although children of any age can catch and transmit SAR-CoV-2, younger children are thus far seemingly less susceptible to infection and, thus, less likely to spread the virus to others. For this reason, studies on vaccines' effects on older children, such as age 12 years and older, may have a greater impact on the scientific community's continued pursuit of vaccines.

Most pharmaceutical companies have initially targeted the adult vaccine market. After successfully developing safe vaccines for adult populations, Pfizer and Moderna have branched out to begin clinical trials in children age 12 years and older.

CMS finalizes rule aimed at cutting lag time of Medicare coverage for breakthrough devices

The Centers for Medicare & Medicaid Services (CMS) finalized a rule in January 2020 granting speedier Medicare coverage decisions on new breakthrough medical devices. The new rule is intended to address the lag time that exists between approval of a new device by the FDA and its associated coverage by Medicare.

Some examples include devices that use implantation or gene-based testing technology to treat cancer or heart disease. CMS officials say the new rule allows Medicare to provide national coverage simultaneously with FDA approval for up to four years before a reevaluation is required.


‘Nanobodies’ from llamas and alpacas could yield new COVID-19 treatment

Scientists from the University of Bonn, the Karolinska Institutet, and Scripps Research Institute have designed a nanobody-based COVID-19 treatment they believe has advantages over traditional antibody treatments. Nanobodies are produced by the immune systems of camelids, including llamas and alpacas.

According to a new study published in Science, researchers were able to synthesize nanobodies capable of attacking multiple sites of the SARS-CoV-2 spike protein by fusing two nanobodies chosen from a llama and an alpaca that were immunized with the virus. The nanobodies also successfully fought off COVID-19 variants in lab dishes.

The lead candidates from this research, DIOS-202 and DIOS-203, are exclusively licensed to DiosCURE Therapeutics, are expected to begin clinical trials this year. DiosCURE hopes the drugs can work as either a new treatment for infected patients or a COVID-19 prevention alternative to vaccines. The smaller size of nanobodies, compared with antibodies, lets them penetrate deeper into tissue. Their increased stability and producibility may also help nanobody-based treatments cost less than their antibody counterparts.

New DNA test identifies secondary, hospital-acquired infections in COVID-19 patients

Scientists from University Cambridge Hospitals, along with Public Health England, have developed a DNA test capable of detecting secondary infections that can potentially occur during COVID-19 treatment, for example, pneumonia associated with ventilator equipment.

The anti-inflammatory drugs typically administered to patients undergoing mechanical ventilation can make patients more susceptible to bacteria and fungi. The new DNA test can both identify a patient's infection and suggest the appropriate course of antibiotics. It is also expected to be significantly faster to administer than the currently used method of culturing bacterial samples in a lab. The Cambridge University NHS Foundation Trust is distributing the new text to health care providers.

Biogen and Apple announce research investigating if iPhones can detect cognitive decline

In a new partnership between neurology and technology, Biogen will conduct a long-term research project with Apple to learn if iPhones and Apple Watches can detect cognitive declines in users. The multi-year, virtual study is expected to commence in 2021. Biogen hopes to pair these research findings with a future Alzheimer's disease drug it plans to bring to market.

The observational study will enroll both young and old adults. The devices will track subtle changes in study participants' movements and interactions with the devices over time that may add up to associate with the earliest signs of cognitive impairment.

Through this study, researchers hope to establish digital biomarkers in brain health that may help speed diagnoses of neurodegenerative diseases and dementia. More timely intervention could lead to lower costs for health systems.

Boehringer Ingelheim joins forces with Google on quantum computing focus

Pharmaceutical company Boehringer Ingelheim aims to bring quantum computing to biopharmaceutical research and development through a new partnership with Google. The three-year project, utilizing Google's Quantum Artificial Intelligence division, will be led by Boehringer's new Quantum Lab.

Boehringer plans to use this emerging technology to simulate the body's biological mechanics at the molecular level in pursuit of new medications. In addition, Boehringer is increasing its investments in machine learning and data science, as well as digital biomarkers and therapeutics.

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