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The company said that its test could overcome sensitivity issues with ultrasound and serum alpha-fetoprotein assays that are used to monitor at-risk patients.
The firm reported on Tuesday that its diagnostics revenues rose 6 percent from a year ago while its biopharma lab services revenues rose almost 2 percent.
With the certification from the NYS Clinical Laboratory Evaluation Program, the company said the test is now available throughout the US.
Eight German associations are calling for changes to be made to the European In Vitro Diagnostics Regulation (IVDR) in a bid to support the continued use of laboratory-developed tests. The ...
The firm said that its overall revenues rose 2 percent year over year and 4 percent on an organic basis with a smaller increase in its life sciences revenues.
The real-time PCR-based companion diagnostic test identifies patients eligible for treatment with Amgen's Vectibix (panitumumab).
NEW YORK — Digital pathology firm Gestalt Diagnostics said on Monday that it has raised $7.5 million through a Series A financing round. The round was led by Cowles Ventures, TVF Funds, Inland Imaging ...
The first $25 million tranche was funded at close and used to retire Exagen's existing term debt facility with Innovatus Capital Partners.
Last week, readers were most interested in a story about Akoya's collaboration to identify markers predictive of response to checkpoint inhibitor therapy.
In one case a firm is alleged to have improperly billed the COVID-19 Uninsured Program while in the other a firm paid and received kickbacks for unnecessary genetic testing.
A number of the Dutch firm's products have received certification under Europe's In Vitro Diagnostic Regulation recently.
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