Tuesday, December 28, 2004

Affymetrix Microarray System Cleared by FDA

Affymetrix, owner and inventor of the GeneChip technology, just took a big step forward with the approval by the FDA of their first system intended for clinical use, the 3000Dx. Apparently, the system will be used to provide in vitro clinical genotyping, such as the Roche AmpliChip(TM) CYP450 Test, which allow "... diagnostic laboratories to identify certain naturally occurring variations in the drug metabolism genes, CYP2D6 and CYP2C19. These variations affect the rate at which an individual metabolizes many common drugs used to treat diseases including depression, schizophrenia, bi-polar disorder, cardiovascular disease treated with beta-blockers and others. Knowledge of these variations, when considered with other contributing factors, can help a physician select the best drug and set the right dose for a patient sooner, as well as avoid drugs that may cause the patient to suffer adverse reactions." The in vitro genotyping market powered by microarray is developing fast and the competition is fierce, but currently Affymetrix got the best microarray technology (by far).


The GCS 3000Dx System is the first microarray system to be cleared by the FDA for diagnostic testing


SANTA CLARA, Calif., Dec. 27 /PRNewswire-FirstCall/ -- Affymetrix Inc., (Nasdaq: AFFX) announced today that the U.S. Food and Drug Administration (FDA) has granted regulatory clearance for the Affymetrix GeneChip(R) System 3000Dx (GCS 3000Dx), an instrumentation system to analyze in vitro diagnostic (IVD) microarrays. This is the first microarray instrument to be cleared by the FDA for IVD use, providing a standardized platform for nucleic acid diagnostics.

"The FDA's decision is another milestone demonstrating Affymetrix' commitment to clinical diagnostic products," said Stephen P.A. Fodor, Ph.D., Chairman and CEO of Affymetrix. "We can now offer our diagnostic partners an FDA-cleared system to develop and commercialize high-quality, reproducible diagnostic assays, such as Roche Diagnostics' AmpliChip CYP450 Test which is currently offered in the European Union."

The FDA clearance of the Affymetrix GCS 3000Dx follows the August ISO certification of the instrument and array manufacturing facilities and the September IVD CE marking of the instrument system in the European Union.

Affymetrix will continue to work with its Powered by Affymetrix(TM) partners to develop genotyping and gene expression diagnostics on the GCS 3000Dx system. Under the program, Affymetrix provides technology and expertise for products that are developed, branded and marketed by the diagnostic partners.

The FDA's clearance of the GCS 3000Dx system represents a major step toward the use of microarrays for clinical applications. Since the early 1990s, Affymetrix microarrays have become the industry-standard in medical research, used in nearly 3,000 peer reviewed publications in areas such as disease classification, mutation detection and gene expression analysis. The detailed molecular snapshot that microarrays reveal should provide clinicians with more accurate diagnoses and allow for more effective treatments.

More about the 3000Dx and the test who got approved by the FDA

World's First Diagnostic Microarray System Launched by Affymetrix in European Union

GeneChip(R) System 3000Dx CE Marked in Accordance With In-Vitro Diagnostic Directive

SANTA CLARA, Calif., Sep 1, 2004 /PRNewswire-FirstCall via COMTEX/ -- Affymetrix, Inc., (Nasdaq: AFFX) today announced the availability of the world's first microarray instrument system for clinical diagnostics. The GeneChip System 3000Dx (GCS 3000Dx) is CE marked (Conformite Europeene) for in-vitro diagnostic use, enabling clinical laboratories in Europe to analyze microarray diagnostics, such as the Roche AmpliChip(TM) CYP450 Test. This test, which looks for genetic variations that can affect drug efficacy and cause adverse drug reactions, is the first CE marked microarray product launched through the "Powered by Affymetrix" partnership between Roche Diagnostics and Affymetrix.

Availability of the new GCS 3000Dx system offers Roche Diagnostics and other "Powered by Affymetrix" partners an in-vitro diagnostic platform to develop innovative genotyping and gene expression array-based assays that will help improve patient care and treatment.

"Affymetrix is committed to developing tools that will improve quality of life," said Stephen P.A. Fodor, Ph.D., Chairman and CEO of Affymetrix. "With the availability of microarray-based diagnostics, the healthcare community will now have access to a scalable and affordable technology to analyze the genetics of human disease."

The GCS 3000Dx instrumentation system comprises a GCS 3000Dx Scanner with AutoloaderDx, a fluidics station FS450Dx, and GCOSDx software. This is an extension of the same platform that has been used in over 1,000 clinical research publications, but is now configured for diagnostic use in the European Union. The release of the Amplichip CYP450 Test builds on Affymetrix' recent ISO certification for its instrumentation and microarray manufacturing facilities, an achievement confirming the highest levels of quality assurance.

The Roche AmpliChip CYP450 Test will allow diagnostic laboratories to identify certain naturally occurring variations in the drug metabolism genes, CYP2D6 and CYP2C19. These variations affect the rate at which an individual metabolizes many common drugs used to treat diseases including depression, schizophrenia, bi-polar disorder, cardiovascular disease treated with beta-blockers and others. Knowledge of these variations, when considered with other contributing factors, can help a physician select the best drug and set the right dose for a patient sooner, as well as avoid drugs that may cause the patient to suffer adverse reactions.

Affymetrix is working to develop a network of partnerships with companies like Roche Diagnostics to create novel array-based diagnostics in both the clinical and non-clinical markets. With this "Powered by Affymetrix" program, Affymetrix manufactures the microarrays and instruments, while the diagnostic partner develops and commercializes the test. The resulting microarray products enable users to examine genomic sequences in more detail than ever before, providing a more efficient and complete method to diagnose a wide range of conditions and create potential solutions.

http://www.affymetrix.com



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