The ruling prevents the FDA rule on LDTs, which is opposed by much of the clinical lab industry and many segments of the broader healthcare industry, from going into effect.
The firm's Innovance Antithrombin assay is used to monitor antithrombin activity levels in hemophilia patients and aid dosing decisions for a routine prophylaxis.
The automated DxC 500 I analyzer has a throughput of up to 800 clinical chemistry tests and 100 immunoassays per hour.
Last week, readers were most interested in a story about the potentially devastating effects that cuts in US funding for tuberculosis may effect.
NEW YORK — Tasso has struck a deal to offer its blood-collection devices in Japan through a new joint venture with Tokyo-based drug development services provider Shin Nippon Biomedical Laboratories, ...
The company presented its results this week at a conference and anticipates that with additional validation early next year, it will be ready to file for regulatory approval.
NEW YORK – Invivoscribe announced Thursday that its test for FLT3 mutations in patients with leukemia has achieved regulatory compliance in the UK and Switzerland.
The company will use the money to advance the development and commercialization of its liquid biopsy cancer detection panels.
The firm's next-generation pancreatic cancer test looks for five biomarkers that are indicative of early-stage disease.
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