|
|
 |
Genomic Health strives
to ease the burden |
 |
 |
New regulation could
impact patient access |
|
 |
More than 530 sites now
enrolling patients |
|
 |
New resource demystifies
genetic and genomic science |
|
 |
Don't miss this event,
hosted by Genomic Health |
|
 |
Genomic Health Corporate Site
www.genomichealth.com
MyTreatmentDecision.com
www.mytreatmentdecision.com
Oncotype DX
www.oncotypeDX.com
|
|
As many of you may be aware, the U.S. Food and Drug Administration (FDA) recently released draft guidances on the regulation and oversight of genetic and genomic tests, which the agency has named "In Vitro Diagnostic Multivariate Index Assays."
At Genomic Health, we believe that this draft guidance represents the first public discussion surrounding FDA's thinking about the regulation of certain laboratory-developed tests. As the agency states, the guidance is intended for public comment and does not establish legally enforceable responsibilities at this time.
Currently, Genomic Health plans to continue its ongoing dialogue with FDA regarding Oncotype DX™, which went through multiple clinical trials among 2,600 patients. Since becoming commercially available in 2004, over 3,400 physicians have ordered a cumulative total of more than 15,000 Oncotype DX test services for their breast cancer patients.
Clinical laboratory services like Oncotype DX are currently regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as administered through the Centers for Medicare & Medicaid Services, as well as by applicable state laws. The Oncotype DX test service is performed at Genomic Health's Redwood City central reference laboratory, which is accredited under CLIA and the College of American Pathology (CAP). The company's licensed clinical laboratory and the Oncotype DX service cleared all required CLIA evaluations before the first patient test service was run and results reported.
Because the regulation of these tests is such an important issue in terms of working together to find the right balance between protecting patient safety and encouraging the development of innovative diagnostics, we welcome the opportunity to participate in shaping any new regulatory policies by providing comment on this draft guidance. Since this draft guidance has the potential to significantly impact patient access to these types of tests, we also encourage all stakeholders, including physicians, advocates and patients, to do the same.
You can read the draft guidance online at www.fda.gov/cdrh/oivd/guidance/1610.html. Additionally, comments can be submitted by mail to the Division of Dockets Management (HFA-305), Food & Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Alternatively, electronic comments can be submitted to http://www.accessdata.fda.gov/scripts/oc/ dockets/ comments/ comments main.cfm? EC_DOCUMENT_ID =1215 &SUBTYP= NEXT&CID= &AGENCY= FDA. Public comments must be submitted by December 6, 2006 and should include the docket reference number 2006D-0347.
|
|