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The services will be offered in certain regions in Europe as a "home brew" and the two firms plan to seek regulatory approval in Europe for Procognia's diagnostic kit.

The contract will expand coverage for MammaPrint by more than 17 million lives, according to Agendia.

"It's possible that we will issue [an] IVDMIA guidance in the future but with this public meeting [scheduled for July], we are addressing LDTs at once in a public dialogue, instead of dealing with subset by subset," an FDA spokesperson told PGx Reporter.

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 Spanish company's Ferrer inCode subsidiary will sell the MammaPrint test in Latin American markets.

An Agendia official said that the company has provided "new, corrected MammaPrint reports" for all of the physicians who received faulty results and has also implemented internal quality-control measures to guard against a similar issue in the future.

Vermillion and its partner, Quest Diagnostics, launched the test earlier this week.

In addition to the NY State permit, Agendia noted that its California lab has been accredited by the College of American Pathologists.

Speaking at the Personalized Medicine World Conference this week, FDA's Elizabeth Mansfield acknowledged that "things are changing hugely" at the agency.

Since the FDA's 2005 preliminary concept paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance. A new white paper from the Personalized Medicine Coalition points out the areas requiring additional regulatory and evidentiary clarity from the agency.


The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.

Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.

Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.

In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.