NEW YORK — ABL Diagnostics said on Wednesday that it has signed an agreement for the distribution of its infectious disease molecular assays in India with Genient Tech Private.

The firm said that it has received approval for a test that combines the Allsheng-developed Auto-Pure 2400 liquid handling platform with Revvity's T-SPOT.TB test.

The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.

Of the 30 companies, three saw their stock prices increase, 26 saw their share prices decline, and one company's share price remained virtually flat month over month.

Last week, readers were most interested in a story about the potentially devastating effects that cuts in US funding for tuberculosis may 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.

Public health labs have handled most testing thus far for the Texas and New Mexico outbreaks, but commercial labs are ...

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.

The automated DxC 500 I analyzer has a throughput of up to 800 clinical chemistry tests and 100 immunoassays per hour.

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 next-generation pancreatic cancer test looks for five biomarkers that are indicative of early-stage disease.

The test can be used to better stratify cancer patients and determine the likelihood of breast cancer metastasizing.