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.
AMP roundup: Vendors showcase same-day NGS, faster prep, DNA/RNA combos
November 7, 2019 -- BALTIMORE - Bruce Carlson, publisher of Kalorama Information, is on the ground at the Baltimore Convention Center for this week's Association for Molecular Pathology (AMP) meeting, reporting on product introductions.  Discuss
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.
Good news for pathology in 2020 Medicare Physician Fee Schedule
November 6, 2019 -- The U.S. Centers for Medicare and Medicaid Services has issued its final rule for the 2020 Medicare Physician Fee Schedule, effective January 1, and pathologists have cause for celebration.
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
CMS plans broader coverage for NGS in breast, ovarian cancer
October 30, 2019 -- The U.S. Centers for Medicare and Medicaid Services (CMS) has proposed broad national coverage for next-generation sequencing (NGS) in Medicare patients to check for germline mutations under certain testing conditions.  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