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More articles about Regulatory News & FDA Approvals

The analyzer is a dedicated instrument for HbA1c analysis that offers twice the throughput of the instrument it replaces.

The assay is designed to detect Group B Streptococcus colonization in pregnant women using vaginal-rectal swab specimens.

The test combines two previously CE marked assays that are based on the company's Nucleosomics platform for identifying and quantifying nucleosome structural features.

The annual list includes guidelines that would clarify regulations for garnering premarket approval or clearance of devices and diagnostics, particularly next-generation sequencing tests.

CMS revoked the Medicare billing privileges of Alere's diabetes unit, Arriva Medical, claiming it had submitted claims for deceased patients.

Mobile apps could one day transform the way diseases are diagnosed, but concerns have been raised about their accuracy and safety.

After a five-year pilot, only one company has successfully taken a test through parallel review, but there is growing industry interest.

The algorithm calculates the risk of lung cancer, and provides a histological determination in the case of a positive result.

Mertz outlined the lab industry group's policy positions after FDA's decision to delay final guidance on regulation of lab tests and upcoming implementation of a payment law.

The guidance may be dead, but the issues underlying the controversy aren't, according to Gibbs, who said the agency can still take enforcement action against specific tests.

According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.

The test is performed in less than an hour using a buccal cheek swab, and runs on Genedrive’s hand-held real-time PCR instrument.

The new women's health and STI tests for the BD Max platform are part of a small, focused panel approach which the firm believes will resonate with physicians and labs.

Admera's 50-gene PGxOne Plus assay can help predict how patients will respond to drug therapy in cardiology, psychiatry, pain management, and oncology. 

The assay runs on the BD Max System, which combines automated real-time PCR extraction, amplification, and detection on a single platform.

The next-generation sequencing-based test is designed to detect bacteria and viruses in blood samples from patients with suspected infections, especially immunocompromised patients.

The FDA-approved complementary assay "can provide insight into the survival benefit that may be achieved" with the treatment, Roche said.

The FDA has approved Merck's Keytruda as a first-line treatment for non-small cell lung cancer in patients with high PD-L1 expression. 

The test can now be used to screen for sickle cell trait, a condition in which an individual carries one of the two abnormal genes responsible for sickle cell disease.

The test enables donor screening laboratories to use PCR-based diagnostic technology to screen donated blood and plasma.