The Massachusetts Institute of Technology spinout has created a new class of activity sensors that query the body and report back clinically relevant information.
A court in San Diego has stated that part of the suit between Quidel and Beckman is void as a matter of law.
With $5.3 million in recent funding, the firm is pursuing a CE-IVD mark and planning a prospective clinical trial for its protein-based prostate cancer test.
The reagent kit is designed to simplify workflow, improve throughput, and reduce hands-on time and labor costs in performing the T-Spot.TB test.
Glycotest's biomarker test for detection of hepatocellular carcinoma calculates the amount of monosaccharide fucose that appears abnormally on specific serum glycoproteins.
The high-sensitivity test runs on the Quidel Triage Meter Pro instrument and joins a growing list of similar tests that have recently received regulatory approvals.
Roche will develop an immunohistochemistry-based companion diagnostic for Daiichi's investigational HER2-targeting antibody conjugate for breast cancer.
Developers of POC STI platforms and assays said that the tests provide convenience, privacy, and quick results in an area of testing in need of these benefits.
Qorvo Biotechnologies and Novel Biomarkers Catalyst Lab are developing prototype cartridge-based HCV cAg assays for confirmatory testing.
The FDA cleared LabCorp's assay for quantitative determination of total cholesterol, high density lipoprotein cholesterol, triglycerides, and apolipoprotein B.
BioMérieux had previously acquired a minority stake in Hybiome, which specializes in automated immunoassays, in July.
Earlier this week, the company closed the sale of its US laboratory business to Quest DIagnostics for $170 million in cash.
The company beat Wall Street estimates, and officials said momentum is building as the firm readies its GeoMx digital spatial profiling technology for launch.
Total revenues rose to $774,000 from $699,000 in the year-ago quarter while sales of the company's OVA1 test were up slightly to 1,981 tests from 1,954.
The firm saw strong growth in respiratory illness assays and lead testing, which was offset by a decline in C. difficile testing.
The review comes at a tumultuous time for the company, which also announced a reverse stock split after failing to meet a Nasdaq listing requirement.
The company said its molecular collection systems products saw the highest revenue growth during the quarter as product revenues rose 6 percent overall.
The firm saw 60 percent revenue growth in molecular diagnostics, including 88 percent growth in its Solana system.
The Vitros HIV Combo test is a fourth-generation test that detects HIV-1 and HV-2 antibodies, and the p24 antigen, resulting in earlier detections of the disease.
The company posted Q3 revenues of $10.6 million, up from $5.7 million in Q3 2017 and beating the consensus Wall Street estimate of $8.5 million.