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More articles about Regulatory News & FDA Approvals

"LDTs have become a lot more like IVDs," said an FDA official. "So the logical basis for a bifurcated regulatory pathway has also faded."

Roche's test becomes the second PCR-based MRSA test approved for clinical use in the US, joining Cepheid's Xpert MRSA/SA nasal assay for the GeneXpert PCR platform.

The illumigene C. difficile molecular amplification test is Meridian's first molecular diagnostic product.

Roche is the latest firm to receive FDA OK for a molecular MRSA test.

The molecular diagnostics firm becomes one of more than 17,000 labs around the world to receive such accreditation.

A number of molecular diagnostic tests that were cleared for emergency use during the 2009 H1N1 influenza pandemic will have to seek full FDA clearance now that HHS has declared the emergency over.

Abbott's system can be used to detect a new strain of chlamydia initially detected in 2008.

The Pharmaceuticals and Medical Devices Agency's decision follows similar decisions by the FDA and EMA in 2008, which allowed data generated using the seven-biomarker panel to be included in the drug approval process.

Epigenomics' PCR-based lung cancer reflex diagnostic test has been validated in a key clinical trial, clearing the way for the test to receive the CE Mark for in vitro diagnostics and for the company to launch the test in Europe in coming weeks.

ImaGenes will become Roche's first certified European provider for CGH, which it adds to its Roche ChIP-chip and DNA methylation services.

The provisions for the EU orphan designation provide incentives to companies developing orphan drugs, including the potential for up to 10 years of market exclusivity and various fee reductions for certain regulatory activities, Quark said.

The FDA said this week that due to "public health concerns, the agency believes it is time to reconsider its policy of enforcement discretion over LDTs."

The AMA's CPT Editorial Panel held a meeting in which stakeholders continued ongoing discussions regarding a new CPT coding structure in the works for molecular diagnostics and genetic tests. The new coding structure is expected to take hold in 2012.

The test can now be broadly used on common clinical FFPE tumor samples from community and research hospitals, the company said.

The company, which recently raised $3 million in Series A financing, plans to file for FDA clearance for its HPV test and a test for HIV tropism.

The firm said the certification covers the design and provision of OGT's CytoSure, Genefficiency, and biomarker discovery products and services.

The letters are the FDA's latest efforts to assert that DTC genomics service providers are using devices that are actually diagnostic products that require marketing clearance.

The test, called Xpert SA Nasal Complete, is the only one designed to detect and differentiate S. aureaus and MRSA colonization in less than one hour, according to Cepheid.

Used on the BD Max System, GBS can be identified in about hone hour in Lim broth, the company said.

The certification was for the firm's lab in Belgium.


The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.