More articles about Regulatory News

At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.

The tests from Asuragen and MolecularMD are designed for use in chronic myeloid leukemia patients, including those receiving tyrosine kinase inhibitor therapy.

The FDA cleared LabCorp's assay for quantitative determination of total cholesterol, high density lipoprotein cholesterol, triglycerides, and apolipoprotein B.

Used with other clinical evidence, Siemen Healthineer's blood-based test aids clinicians in assessing the fibrosis stage of chronic liver disease.

The unique, test-specific PLA codes make it easier for insurers to identify tests and apply positive or negative coverage policies, billing experts say.

The Vitros HIV Combo test is a fourth-generation test that detects HIV-1 and HV-2 antibodies, and the p24 antigen, resulting in earlier detections of the disease.

Newly announced changes will enable more hospital outreach laboratories to submit lab pricing data, but lab groups say more changes are needed.

The genetic testing community is having a tough time deciphering FDA's intentions based on its authorization of 23andMe’s PGx test and a recent safety alert.

While companies are expected to have their IVDs certified under the new regulation by 2022, manufacturers are frustrated by the slow pace of the certification process.

The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.

The cleared system enables testing on a postage stamp-size piece of film along with advanced optics for precise results, Ortho said.

The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.

The association is concerned that waived testing sites are operating with insufficient oversight and compromising patient safety, and is asking Congress to investigate.

The instrument is a centrifuge/reader combo that automatically reads and transfers blood type and antibody screening results to patient data management software.

Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.

The device is designed to be used with the Inova Diagnostics' Quanta Flash assay for the detection of fecal calprotectin in human stool samples.

The agency granted clearance for the Ansh Labs PicoAMH ELISA test, which measures the amount of Anti-Müllerian hormone in the blood.

Agena has an ongoing partnership with Guangzhou-based DaRui to develop MassArray-based diagnostics for cancer and inherited diseases for the Chinese market.

The a single-tube, multiplex real-time PCR-based MeltPro High Risk HPV test identifies 14 high-risk genotypes of human papillomavirus  and was previously CE marked.

With CE-IVD marking, the melt curve analysis-based screening assay is available for sale in the EU and other areas that recognize the designation.

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