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Questions to ask about
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Genomic Health Corporate Site
www.genomichealth.com
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www.mytreatmentdecision.com
Oncotype DX
www.oncotypeDX.com
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There has been much news recently about the appropriate regulatory oversight of genetic and genomic tests. As background, clinical laboratory services such as 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 vast majority of the 1,700 genetic tests in use today — such as those for HIV, cystic fibrosis, and other cancers — are provided as laboratory services regulated under CLIA. With the development of Oncotype DX, Genomic Health followed the precedent set by over 1,000 high-complexity laboratory tests — which are used every day in clinical practice — by taking the established path for certification via CLIA.
However, as many of you may be aware, the FDA released a draft guidance on September 7, 2006, on the regulation and oversight of a subset of genetic and genomic tests including Oncotype DX, which the Agency has named "In Vitro Diagnostic Multivariate Index Assays" (IVDMIAs). As the Agency states, the guidance is intended for public comment and does not establish legally enforceable responsibilities at this time, nor does the FDA intend to regulate all laboratory-developed tests. In addition, the FDA has not yet made any definitive decisions on the appropriate oversight of IVDMIAs, or issued a timeline for formalizing new regulatory policy.
Genomic Health — along with several other companies and industry groups — has been in active discussion with the FDA on this issue since the draft guidance was released. Currently, we are continuing our dialogue with the Agency regarding the appropriate process for oversight of Oncotype DX, which went through multiple clinical trials involving 2,600 patients. Since the assay became commercially available in 2004, over 5,500 physicians have ordered a cumulative total of more than 27,000 Oncotype DX assays for their breast cancer patients. In addition, 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 and state reviews before the first patient test service was run and the first set of results were 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 have welcomed the opportunity to participate in shaping any new regulatory policies and have therefore provided comment on this draft guidance.
Several advocacy organizations — including the Research Advocacy Network and the Genetic Alliance — have hosted conference calls and discussions over the last few months to assist the advocate community in gaining a better understanding of this complex issue. Additionally, many advocacy organizations participated in the public comment period that the FDA initiated in conjunction with the draft guidance, by presenting at public workshops and by sending their comments and concerns to the Agency to ensure that their voices are heard.
We at Genomic Health would like to thank all the individuals and organizations that took an interest in this FDA guidance document and chose to participate in the public comment process. Your perspective is vital to ensuring the well-being of patients, including those you serve today as well as those that your organizations will support in the future.
We look forward to hearing the FDA's response to the community's letters and public comments. We will continue to monitor the situation and keep you apprised of the Agency's next steps regarding additional announcements and the development of new regulatory policies and procedures for genetic and genomic tests such as Oncotype DX.
To read more about the draft guidance, please go to: www.fda.gov/cdrh/oivd/guidance/1610.html.
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