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The firm sells a rapid, point-of-care, PCR platform for infectious disease diagnostics, including SARS-CoV-2, influenza, respiratory syncytial virus, and strep A.
The BioFire Defense subsidiary of BioMérieux obtained clearance for its FilmArray Global Fever Panel External Control Kit, used with the FilmArray Global Fever Panel.
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.
Credo Diagnostics recently received the CE mark for the coronavirus test, which can provide results in 20 minutes.
The firm aims to stabilize and protect its existing molecular diagnostics business over the next 12 to 18 months, CEO Jack Kenny said.
Some at-home infectious disease tests and sample collection kits exist in a murky regulatory realm, and their sale to patients is troubling laboratorians and clinicians.
Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
The spread of POC testing technology along with changes in state regulations and pharmacist education are driving an increase in pharmacist-administered testing.
The test detects Group A Strep in throat swab samples using the firm's rapid molecular diagnostics instrument called Revogene.
The test can detect resistance to two of the most commonly prescribed antibiotics used to treat strep throat, and could potentially be adapted for point-of-care use.