Abbott CEO Robert Ford called cancer testing a "critically important market" that the firm has made a priority to move into.
InnotiveDx's UTI diagnostic technology provides bacterial identification and antimicrobial susceptibility test results in less than 60 minutes.
The agency would down-classify nucleic acid-based tests for use with a corresponding approved therapy product to Class II devices from Class III.
The US Food and Drug Administration granted clearances for PCR-based infectious disease tests from multiple companies as well as other in vitro diagnostic tests.
Last week, readers were most interested in a story about a proposed acquisition by Abbott of Exact Sciences that would launch Abbott into the cancer testing space.
The test is expected to be used by payors and healthcare systems to identify people most likely to respond to the weight-loss drugs.
PrognomiQ announced the initial launch of its ProVue blood test while Mercy presented new data detailing the performance of its Halo lung cancer test.
A slew of new studies and reports suggest that new molecular approaches may soon help reduce the global burden of tuberculosis.
NEW YORK – Alzheimer's testing firm C2N Diagnostics said Monday that it has received a laboratory permit from the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP).
NEW YORK – Agilent Technologies said after the close of the market Monday that its fiscal fourth quarter revenues grew 9 percent year over year. For the three months ended Oct. 31, the Santa Clara, ...
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