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Medicare Firm to Cover Genomic Health’s Oncotype Dx

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The National Heritage Insurance Company, a Medicare contractor, has decided to cover Genomic Health’s Oncotype Dx test — a move that could guide the course of reimbursement decisions for future pharmacogenomic diagnostics.

Redwood, Calif.-based Genomic Health sends all of its Medicare bills through the NHIC, the state’s Medicare contractor. “A local coverage decision by [the carrier] has the impact of essentially providing Medicare coverage for patients all across the US, because those samples are sent from all 50 states,” although they are all run in Genomic Health’s laboratory, according to Randy Scott, the firm’s CEO.

The Oncotype Dx test is not truly a pharmacogenomic test. It is prognostic, using the expression level of 21 genes to estimate the chance of cancer recurrence and 10-year patient survival, as well as the likely benefit of early-stage chemotherapy, in node-negative, estrogen-receptor-positive breast cancer patients.

But as a molecular diagnostic that can help guide therapy, Oncotype Dx may offer important lessons for successor products that are more closely tied to pharmaceutical response. The test also has the odd distinction of receiving public recognition by Larry Lesko, director of the FDA’s Office of Clinical Pharmacology and Biopharmaceuticals, who cited Oncotype Dx as an example of a promising model for pharmacogenomics-based diagnostics during an address at a conference held early last year.

Corroborating the point, Felix Frueh, associate director of the CDER and head of the FDA’s Interdisciplinary Pharmacogenomics Research Group, said last May that his group “would like to see more of these [tests], and review the performance of these, because this is very early in the game, and we’re thinking that this might be setting a trend for seeing more of these.”

Scott credits support from the oncology community for the reimbursement decision, which the firm received after its test had been on the market for about two years.

— Chris Womack

PATENT WATCH
US Patent 6,986,992. P450 single nucleotide polymorphism biochip analysis. Inventors: Buena Chui, Robert Elghanian, Vineet Gupta, Krishnamurthy Jayaraman, Gretchen Kiser, Changming Li,  et al. Assignee: Amersham Biosciences AB (Uppsala, SE).  Issued: January 17, 2006.

This invention relates to methods and compositions for determining SNPs in P450 genes. Specifically, the invention describes a variety of methods to decrease self-extension of interrogation probes. It describes a variety of array platforms and provides a unique collection of SNP probes on one assay, primer sequences for specific amplification of each of the seven P450 genes, and amplicon control probes to evaluate whether the intended P450 gene targets were amplified successfully.


US Patent 6,987,097. Methods of optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders. Inventors: Ernest Seidman and Yves Théorêt. Assignee: Hospital Sainte-Justine. Issued: January 17, 2006.

This application describes a method of optimizing therapeutic efficacy and reducing toxicity associated with 6-mercaptopurine drug treatment of an immune-mediated gastrointestinal disorders, such as inflammatory bowel disease.


Clinical Data announced plans to consolidate its operations into two divisions to focus its efforts in pharmacogenomics and metabolomics. The new businesses will be called Clinical Data Molecular and Vital Diagnostics. The former will be comprised of Clinical Data’s two 2005 acquisitions — Genaissance and Icoria — while the latter will consolidate the company’s previously owned subsidiaries.

Third Wave settled a patent-infringement suit that it filed against Digene last October. The suit concerned Third Wave’s human papillomavirus diagnostics, the selling of which the company was hoping to get a court ruling to support. What’s more, the companies have established a legal cease-fire, agreeing not to sue each other over HPV patents for one year.

NIH announced plans to issue a request for applications concerning genome-wide association studies to identify genetic components related to heart, lung, and blood disorders and their risk factors using existing population, family, and clinical studies.

Metabolon closed an $8 million Series B funding round, in which investors included Sevin Rosen Funds, Aurora Funds and Trelys Funds. The new investor on the block for this round — Harris & Harris Group — contributed $2.5 million.

Decode Genetics bought Urdur, Verdandi, Skuld, a privately held Icelandic cancer research company.

Datapoint
12%
Pfizer’s slice of the Perlegen pie. The companies closed the $50 million deal one day before penning an unrelated, four-year research alliance. Pfizer has agreed to purchase an additional $25 million in stock if Perlegen files an IPO this year.
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