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Genalyte

Diagnostic Companies Progress in Bringing Routine Testing to Point of Care
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Regulatory clearances and product demonstrations indicate routine POC testing is becoming technically feasible, though commercial questions remain.

Genalyte Receives FDA 510(k) Clearance for TSH Assay on Point-of-Care Maverick Device

According to the company, the TSH assay delivers results in roughly 30 minutes and is the first quantitative immunoassay cleared on a silicon chip-based device.

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.

Genalyte Raises $50M in Private Financing Round

Genalyte will use the funds to expand the test menu for the Maverick Diagnostic System and deploy the platform in clinical and retail settings.

Spectrum Solutions Saliva Collection Device, Access Bio, Genalyte Coronavirus Tests Get FDA EUAs

Spectrum Solutions' specimen collection device is used with SARS-CoV-2 saliva tests from DxTerity Diagnostics and RUCDR Infinite Biologics.