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candidiasis

T2 Biosystems Candida Assay Cleared by FDA for Pediatric Use

The Lexington, Massachusetts-based diagnostics maker said the clearance enables it to sell the test to more than 200 children's hospitals.

T2 Biosystems Submits 510(k) to FDA to Expand Use of Candida Panel

The firm is seeking clearance of the test, which detects five Candida species directly from blood in three to five hours, for pediatric testing. 

With C. Auris Proliferating, NYSDOH Wadsworth Center to Fund Device Development for POC Tests
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For the first time ever, the center is funding the development of diagnostic systems — specifically for the development of three devices to detect the infection. 

FDA Clears Two Hologic Vaginitis Assays

The Aptima BV test detects bacterial vaginosis and the Aptima CV/TV detects and differentiates candida infections from trichomonas.

T2 Biosystems Q3 Revenues Rise 127 Percent

The firm beat Wall Street analyst estimates for revenues and earnings per share in the third quarter.