Point-of-Care Testing
News on technologies and applications for point-of-care testing.
Cue Health to Implement Shareholder Rights Plan
The plan has a one-year term and was adopted in response to a rapid accumulation of shares by a third party, the company said.
QuidelOrtho Nabs CLIA Waiver for COVID-19 Antigen Test
The test runs on the company's Sofia 2 fluorescent immunoassay analyzer, both of which received de novo authorization from the FDA earlier this year.
BioMérieux Submits Dual FDA Marketing, CLIA Waiver Application for Respiratory, Sore Throat Panel
The French diagnostics maker is seeking both 510(k) clearance and a CLIA waiver for the multiplex PCR test, which can be used at the point of care.
Kephera Nabs $5.7M in NIAID Grants for Lyme, Chagas Tests
The money will be used to aid development and clinical testing of assays to aid identification of Lyme disease and monitor response to treatment for Chagas disease.
Diagnostic Companies Aim to Bring Routine Testing to Point of Care, but Face Significant Hurdles
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The Theranos scandal still hangs over the space, but several firms are working to move miniaturized clinical analyzers into settings like doctors' offices.