Helix Platform Granted the 1st and Only FDA Authorization for a Whole Exome Sequencing Platform
Helix advises this marks the first time such a broad, sequencing-based device has been authorized by the FDA.
January 11, 2021
BIOTECHNOLOGY
Medical Device News Magazine reports breaking biotechnology news including new biotech developments, pharmaceuticals and more.
Budapest-based ZTA Biotech Develops ELISA Protocol for COVID-19 IgG Antibody Detection
This new detection method represents a great step forward in determining if patients have had COVID-19 and if they might still have immunity to the disease.
January 6, 2021
CareVax Vaccine Tracking Program Launches
CareVax is being released in the US first, internationally in early Q1, and is poised to work with government public health agencies at the federal, state, local county, and city levels offering a data-driven solution that can provide real-time analytic, surveillance and market intelligence in order to make more informed care decisions.
January 5, 2021
Mologic Receives CE Mark Approval for Professional-Use COVID-19 Rapid Antigen Test
The company notes the test will provide health professionals with accurate detection of the nucleoprotein of the SARS-CoV-2 virus in respiratory swabs, within 10 minutes.
December 24, 2020
OraSure Technologies Reports OMNIgene®·ORAL Device Now Included in EUA Amendment Granted to 3B BlackBio Biotech India for SARS-CoV-2 Test
The company advises this EUA amendment will allow 3B BlackBio Biotech’s North American distributor, Genophyll Enterprises, to expand saliva COVID-19 PCR-based viral diagnostic testing across the U.S. as well as from their upcoming New Jersey-based laboratory.
December 23, 2020
Briotech Expands: Company Moves to a 82,000 SF Class-A Wesmar Building in Woodinville, Washington
Briotech notes that in addition to its flagship product, Briotech Topical Skin Spray, Briotech produces Super Oxidized Saline for oral use, and an EPA approved Multi Surface Sanitizer + Disinfectant effective against coronavirus (the novel SARS-CoV-2 pandemic virus that causes COVID-19).
December 23, 2020