GBC Blog
FDA Authorizes New Device to Help Diagnose Pediatric Autism
Posted 02 June 2021 | By Joanne S. Eglovitch The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder (ASD) in children aged 18 months through 5 years. The device was developed by Cognoa, a company based in Palo Alto, CA, that…
Read MoreMirimus, Inc. Announces Publication of Scientific Paper Highlighting Pooled Saliva-Based Testing as an Effective, Cost-Efficient Approach to COVID-19 Surveillance Testing for Schools
NEW YORK, Feb. 22, 2021 /PRNewswire/ — Mirimus, Inc., a leader in conducting high-volume, high-quality PCR testing, today announced the publication of a scientific paper, titled, “Pooled Surveillance Testing Program for Asymptomatic SARS-CoV-2 Infections in K-12 Schools and Universities,” available for preprint on MedRxiv as it undergoes scientific peer review for potential publication. The paper…
Read MoreRADx Tech Inks Additional Contracts for COVID-19 Tests and Supplies
January 13, 2021The National Institutes of Health has awarded three new contracts totaling $36.7 million for the development of new COVID-19 diagnostic testing technologies and production of specimen collection kits and swabs. The Rapid Acceleration of Diagnostics (RADx) initiative has advanced the scale-up of 25 testing projects since July 2020, which now include lab-based, point-of-care,…
Read MoreFirst Over-the-Counter Covid-19 Test Gets FDA Clearance
The U.S. Food and Drug Administration on Tuesday authorized a Covid-19 test that can be administered and processed at home, the first such test allowed to be sold over-the-counter at drugstores or other retail locations without a prescription. The antigen test, made by Ellume USA LLC, is a single-use, disposable test that searches for pieces…
Read MoreStreck Cell-Free DNA BCT® Receives U.S. FDA De Novo Clearance
LA VISTA, Neb., Sept. 11, 2020 /PRNewswire/ — Streck Cell-Free DNA BCT received U.S. Food and Drug Administration De Novo clearance for In Vitro Diagnostic use when paired with the Guardant360 CDx liquid biopsy assay. Cell-Free DNA BCT is the first and only circulating nucleic acid first blood collection tube to be cleared for use…
Read MoreGTEx Consortium Releases Fresh Insights into How DNA Differences Govern Gene Expression
September 10, 2020 – Broad Institute of MIT and Harvard Summary: Scientists have completed a wide-ranging set of studies documenting how small changes in DNA sequence can impact gene expression across more than four dozen tissues in the human body. These studies, released in a set of 15 articles, constitute the most comprehensive catalog to…
Read MoreCOVID-19 Is Transmitted Through Aerosols. We Have Enough Evidence, Now It Is Time to Act
Many months into the COVID-19 pandemic, the coronavirus is still spreading uncontrolled through the U.S. Public health authorities including the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) tell us to remain six feet apart, wash our hands, disinfect frequently touched surfaces, and wear masks. But compliance with these measures—especially masks—is mixed, and…
Read MorePeople with Hidden Immunity Against Covid-19
BBC.Com 19-July-2020. While the latest research suggests that antibodies against Covid-19 could be lost in just three months, a new hope has appeared on the horizon: the enigmatic T cell.T The clues have been mounting for a while. First, scientists discovered patients who had recovered from infection with Covid-19, but mysteriously didn’t have any antibodies against…
Read MoreU.S. FDA OKs Testing of Pooled Samples for COVID-19
The U.S. Food and Drug Administration on 19 July approved testing pooled batches of samples for the COVID-19 virus, a strategy supporters say could help screen more people faster and at less cost than through individual tests. The strategy saves reagents by combining samples from four people and running a single test. If the batch…
Read MoreModerna’s COVID-19 Vaccine Shows Early Promise in Phase I Trial
Jul 15, 2020 By Mark Terry (BioSpace) – In mid-May, Moderna released positive interim data from its Phase I trial of mRNA-1273, its mRNA vaccine against SARS-CoV-2, the virus that causes COVID-19. It was in a press release and although the company shares rocketed, critics immediately took aim at what they felt was a lack…
Read More