The company's Check4 electrochemical detection platform can detect nucleic acid targets from blood or saliva samples in less than five minutes.

The PCR-based point-of-care test runs on the Cobas Liat platform and returns results for three Bordetella species in 15 minutes.

The analyzer integrates clinical chemistries, immunoassays, and hematology assays into a single plug-and-play instrument.

Of the 30 companies in the index, 25 saw their share prices increase and four saw their stock prices decline, while one company was flat month over month.

The blood-based test is intended to aid in the decision for prostate biopsy for men older than 50 with elevated PSA levels.

Last week, readers were most interested in a story about FDA's plan to reclassify some tests that now require PMAs to require only 510(k) clearance.

Abbott CEO Robert Ford called cancer testing a "critically important market" that the firm has made a priority to move into.

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.

Breaking news on diagnostics business, policy, and funding. Real-time updates on clinical labs and the in vitro diagnostics market from 360Dx.

The agency would down-classify nucleic acid-based tests for use with a corresponding approved therapy product to Class II devices from Class III.

360Dx regularly updates this tracker to provide readers with accurate information on the regulatory status of these tests in the US, European, and Asian markets.

InnotiveDx's UTI diagnostic technology provides bacterial identification and antimicrobial susceptibility test results in less than 60 minutes.