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Sequenom said in an SEC document that its SensiGene test, which the company believes was cited by the FDA for being improperly marketed without FDA approval, is an LDT and meant "solely for use within our CLIA-certified and CAP-accredited laboratory."

Gen-Probe said the assay is the only FDA-cleared molecular diagnostic test that can simultaneously detect seasonal A/H1, seasonal A/H3, and 2009 H1N1.

Overshadowed by a smarting GAO report on DTC genetics firms' failings, FDA suggests to lawmakers that it may be developing a new approach for regulating consumer genetics companies.

FDA wants a number of genetic testing firms to provide information about why their tests are being sold legally and that their services should not require approval as medical devices.

According to one high-ranking FDA official, the agency is considering downgrading in risk classification certain regulated tests as a way to manage its limited resources; phasing in regulation of LDTs that aren't currently regulated; collaborating with the NIH to develop a test registry that could serve FDA's purposes for keeping an eye on all test developers; and possibly enlisting the help of third-party inspectors to help the agency with its increasing regulatory burden.

"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.


Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.

Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.

The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.

This week in Science: Neanderthal Y chromosomes replaced by Homo sapiens Y chromosomes, and more.