Roche's SARS-CoV-2 antibody test up and running at more than 20 U.S. labs
May 20, 2020 -- Roche announced its Elecsys anti-SARS-CoV-2 antibody test is being used at more than 20 commercial and hospital lab sites throughout the U.S.
Study calls for hepatitis D screening in at-risk patients
May 20, 2020 -- Patients with hepatitis B should be also be screened for hepatitis D, as coinfection puts them at greater risk for liver cancer, according to a study set to be published in the Journal of Hepatology.
Beckman Coulter debuts new tabletop hematology analyzer
May 20, 2020 -- Beckman Coulter has launched its DxH 690T tabletop hematology analyzer in the U.S.
BioRad teams with Biodesix on COVID-19 total antibody test
May 20, 2020 -- Bio-Rad Laboratories and lung cancer diagnostics firm Biodesix have joined forces to launch a serology test for detecting COVID-19 antibodies.
Pathnostics debuts COVID-19 PCR test
May 20, 2020 -- CLIA-certified Pathnostics has launched a COVID-19 polymerase chain reaction (PCR) laboratory developed test that it is positioning as easy to administer, using a specimen from a simple nasal swab.
Canadian researchers develop test to track dietary fats
May 19, 2020 -- Canadian researchers from McMaster University in Hamilton, Ontario, have developed a blood test that tracks dietary fat intake. Results from a study using the test were published March 31 in the Journal of Lipid Research.
Invivoscribe garners expanded FDA approval for LeukoStrat CDx
May 19, 2020 -- Invivoscribe said that the U.S. Food and Drug Administration (FDA) has approved a premarket approval application supplement for its LeukoStrat CDx FLT3 mutation assay, enabling sale as an in-house IVD kit.
Quidel nets EUA, CE Mark for Lyra Direct SARS-CoV-2 assay
May 19, 2020 -- Quidel has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and the CE Mark for its Lyra Direct SARS-CoV-2 assay, a new version of its Lyra real-time reverse transcription polymerase chain (RT-PCR) test that skips upfront sample extraction.
Feds arrest Georgia woman for genetic, COVID-19 testing fraud
May 18, 2020 -- Federal investigators have arrested a woman in Georgia on charges that she defrauded Medicare by allegedly paying and receiving kickbacks for referring people for cancer genetics and COVID-19 lab tests.
AACC provides a steer on antibody testing for novel coronavirus
May 18, 2020 -- The American Association for Clinical Chemistry (AACC) is advising that antibody testing for the novel coronavirus should be limited to diagnostics that have emergency use authorization (EUA) from the US. Food and Drug Administration (FDA) or developed by a CLIA-certified lab.