Stakeholders noted that challenges like supply chain breakdowns and staffing shortages are too global in scope for any one ...

The facility is expected to allow Hemex to scale up access to its point-of-care sickle cell diagnostic testing platform in high-burden countries.

Stakeholders noted that challenges like supply chain breakdowns and staffing shortages are too global in scope for any one laboratory to effectively prepare for on its own.

The company's Liaison TSH-R Ab assay is used to aid the diagnosis of the autoimmune disorder Graves' disease and monitoring of treatment effectiveness.

Titled the RESULTS Act, the bill would use third-party private-payor data to set Medicare lab payment rates, addressing a ...

The new rule, which went into effect Sept. 19, returns FDA's regulations on in vitro diagnostics to their previous form, which did not explicitly give FDA authority over LDTs.

The scientists said that the test could help clinicians overcome a lack of specificity in prostate-specific antigen tests and ...

The company plans to raise money this fall to support the continued development of its head-and-neck cancer testing platform and oral squamous cell carcinoma test.

The company's clinical chemistry test uses the NGAL biomarker to determine a patient's risk of acute kidney injury.

Compared to the firm's previous PGx offering, the new service is somewhat smaller in terms of content and better supported by ...

NEW YORK – Despite a sharp fall in BioAffinity Technologies' share price over the past year, its CEO said that the firm remains on solid footing, and it will continue its work to expand the reach of ...

The submitted test runs on the firm's point-of-care instrument and detects four respiratory pathogens within 10 minutes directly from patient nasal swab samples.