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.

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.

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

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

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

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 25-Hydroxy Vitamin D test runs on Roche's Cobas I 601 analyzer and is the first in Roche's pipeline for the Cobas Mass Spec solution.

The US-based molecular diagnostic laboratory's PCR-based test detects persistent human papillomavirus infection, a main cause of oropharyngeal cancer.

The firm said that it has been awarded funding to support the development of its cancer detection technology and a test for oropharyngeal squamous cell carcinoma.