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.
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.
The agency would down-classify nucleic acid-based tests for use with a corresponding approved therapy product to Class II devices from Class III.
InnotiveDx's UTI diagnostic technology provides bacterial identification and antimicrobial susceptibility test results in less than 60 minutes.