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Snippets: Feb 11, 2009

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FDA, SAEC Release First Data on Adverse Events

A collection of new data about the genetics associated with drug-induced serious skin rashes has been released by the US Food and Drug Administration and the International Serious Adverse Events Consortium.

The FDA said this week that the release of this genetic data about serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with adverse drug reactions could be used to help predict which individuals will experience them.

The SAEC is a nonprofit that includes pharmaceutical companies, the Wellcome Trust, and academic institutions that study drug-induced reactions. It began its research efforts nearly a year and a half ago.

This release of data on skin rashes is the first made available through the partnership, FDA said. These samples were from serious skin rashes and matched controls that were collected by GlaxoSmithKline in London and donated to the consortium specifically for this research.

Using these samples, the SAEC identified "numerous genetic associations that may contribute to an individual's risk of developing serious drug-induced skin reactions," FDA said.

"The SAEC has fulfilled a key goal of the Critical Path Initiative by providing the research community with public access to new genomic data on adverse drug events," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

"This consortium has taken a significant step forward by promoting open sharing of drug safety data. This type of cooperation has the potential to lead to more personalized approaches to medicine that can reduce a patient's risk for experiencing an adverse drug event," she said.

Arthur Holden, who founded and chairs the SAEC, said this release of data is "invaluable" for researchers, and they can use it to "improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events."

Researchers who enter into a data use agreement can obtain access to the data for free in order to generate custom data inquiries and obtain immediate results on the genetic basis of adverse drug events.


Clinical Data Inks Blue Cross Contract for PGx Cardiac Test

Clinical Data has signed an agreement with the Blue Cross and Blue Shield Association to offer its genetic tests for inherited cardiac syndromes to BCBSA member companies.

The agreement will give BCBSA's 39 member companies access to the Familion Long QT Syndrome test, which is offered through Clinical Data's PGxHealth division. The individual insurers will be able to independently enter into an ancillary contract to offer the tests to their members.

The Familion group of tests detect mutations that can cause cardiac channelopathies or cardiomyopathies, such as Long QT Syndrome; Brugada Syndrome; Catecholaminergic Polymorphic Ventricular Tachycardia; Hypertrophic Cardiomyopathy; and Arrhythmogenic Right Ventricular Cardiomyopathy

Clinical Data said that nearly 200 million patients in the US are now covered by providers and private payers who offer access to the firm's genetic tests.


HDC Inks Dx Deals with Abbott, Quest

Health Discovery Corp. announced last week that it had signed two diagnostics deals with Abbott and clinical lab company Quest Diagnostics.

Under the first alliance, Abbott acquired co-exclusive clinical lab rights and exclusive in vitro diagnostics rights to commercialize HDC's tissue-based and urine-based prostate cancer tests. The firm did not disclose any additional terms of the agreement.

Under the second deal, HDC licensed biomarkers to Quest for development of a non-invasive, urine-based prostate cancer test. Savannah, Ga.-based HDC will receive payments, royalties, and additional undisclosed financial considerations as part of the agreement.


New FDA Effort to Take Aim at Genomics

The US Food and Drug Administration is creating a new position at the Office of FDA's Chief Scientist that will focus on the agency's genomics-related programs, FDA said last week.

Frank Torti, acting commissioner of food and drugs, mentioned the new position in a weekly address on the FDA's website. He said the new hire will be dedicated to "coordinating and upgrading our agency's activities in genomics and the related fields of science that are involved in the analysis of complex DNA, protein, and smaller expression platforms."

The first person to hold this post will be Liz Mansfield, who has been involved in policy and scientific positions at FDA and in the private sector. Mansfield will work on FDA's goal of providing agency scientists with tools and personnel capable of high-level analysis of complex genetic data.

In his address, Torti said that the "emphasis on a coordinated genomics effort" resulted from an FDA retreat last summer that focused on genomics, recommendations from the FDA Science Board, and "our own internal planning."

In order for personalized medicine to advance, Torti explained, "FDA must use the most advanced tools for evaluating the new and frequently highly complex products regulated by our agency. Further integration and coordination of the latest genomic technology into the FDA's processes and decision-making will better protect and promote the public health."

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