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.
Promega, Merck team up on Keytruda companion test
November 6, 2019 -- Promega and Merck announced a collaboration to develop a polymerase chain reaction companion diagnostic to evaluate microsatellite instability for use in guiding treatment with the blockbuster programmed cell death 1 (PD-1) inhibitor pembrolizumab (Keytruda).
Siemens overcomes lagging Diagnostics numbers in Q4
November 4, 2019 -- Despite lagging performance in its Diagnostics business, Siemens Healthineers posted strong overall financial results for its fourth quarter, with revenue growing 8% after currency adjustment.
Agena debuts PGx panel for hybrid alleles
November 4, 2019 -- Agena Bioscience has introduced the VeriDose pharmacogenomics (PGx) research-use-only panel that can detect CYP2D6 copy number variation in the presence of the CYP2D6/CYP2D7 hybrid alleles.
Blood test for autoantibodies shows promise in breast cancer
November 4, 2019 -- Screening for autoantibodies against tumor antigens in blood shows promise for detecting early-stage breast cancer, researchers at the University of Nottingham reported on November 3 at the U.K. National Cancer Research Institute (NCRI) Cancer Conference.
CAP offers kidney pathology guide in pictures
November 1, 2019 -- The College of American Pathologists (CAP) has released a guide to the pathology of kidney disease targeted at generalists in the specialty and also nephrologists.
AACR launches $36M genomics project with big pharma
October 31, 2019 -- The American Association for Cancer Research (AACR) is launching a $36 million research project in collaboration with big pharma to expand its Genomics Evidence Neoplasia Information Exchange (GENIE) clinical genomics databank.
RareCyte introduces new staining kits for liquid biopsies
October 31, 2019 -- Seattle-based RareCyte has introduced two new immunofluorescence staining kits for prostate and breast cancer biomarkers in liquid biopsy samples.
Qiagen TB blood test headed for wider global use
October 31, 2019 -- Qiagen's Quantiferon-TB Gold Plus blood test for detecting latent tuberculosis (TB) made the list of diagnostics in the international Stop TB Partnership Global Drug Facility product catalog.