Bio-Rad launches QX One PCR system at AMP 2019 November 11, 2019 -- Bio-Rad Laboratories announced the release of its QX One Droplet Digital polymerase chain reaction (ddPCR) system at the Association for Molecular Pathology (AMP) meeting, held November 7-9 in Baltimore.
PathAI reports algorithm on par in PD-L1 immunotherapy studies November 7, 2019 -- PathAI reported that its pathology artificial intelligence algorithm performed on par or better than board-certified pathologists in retrospective immunotherapy studies slated for release on November 9 at the Society for Immunotherapy of Cancer annual meeting.
Vela wins FDA clearance for HIV-1 genotyping NGS assay November 6, 2019 -- Vela Diagnostics USA has garnered U.S. Food and Drug Administration (FDA) marketing approval for its Sentosa SQ HIV-1 genotyping assay, a test designed to detect HIV-1 drug resistance mutations using next-generation sequencing (NGS) technology.
FDA flags persistent problems with biotin interference November 5, 2019 -- The U.S. Food and Drug Administration (FDA) on November 5 issued a warning regarding lab tests that have not yet been addressed for biotin interference. The communiqué instructs lab personnel to communicate more with patients and health providers to help avoid false reporting. Discuss
Hahn nominated to lead FDA as commissioner November 4, 2019 -- Radiation oncologist Dr. Stephen Hahn has been nominated as commissioner of the U.S. Food and Drug Administration (FDA). The nomination is drawing plaudits from the American Society for Radiation Oncology and other cancer organizations. Discuss
Disability agency urges crackdown on prenatal genetic testing October 31, 2019 -- The U.S. National Council on Disability is calling for greater regulation of genetic testing -- with a particular focus on noninvasive prenatal testing (NIPT) -- in a new report. The agency analyzed the game-changing effects that NIPT has had on genetic testing and analysis. Discuss
Precision medicine brings sequencing to the clinical lab October 25, 2019 -- Precision medicine and other applications are driving demand for next-generation sample preparation techniques in a market worth $1.8 billion in revenue in 2018, with double-digit growth expected over the next five years, according to a new report from business intelligence firm Strategic Directions International (SDi). Discuss