Genomic Health and Pfizer plan to develop a genomic test based on the diagnostic company’s Oncotype DX technology to gauge the risk of post-operative kidney cancer recurrence.
The project, announced this week, is designed to create a test for patients with Stage I-III, localized, clear cell-type renal carcinoma.
In an e-mail to Pharmacogenomics Reporter, a Genomic Health spokesperson said that the company will hold commercialization and IP rights to any product developed during the collaboration.
According to Genomic Health, the clear cell-type of renal carcinoma is the most common type of kidney cancer in adults, affecting roughly 25,000 people each year in the US. In addition, early-stage kidney cancer often recurs following surgical resection, and there is no way to identify in advance which patients are at risk for the recurrence.
The alliance pairs Genomic Health’s tried-and-tested diagnostic platform with Pfizer’s sway with payors, which could widen the market for the diagnostic company’s existing testing platform.
"This collaboration further expands our efforts to develop genomic tests for a variety of cancers that allow physicians and patients to individualize treatment decisions," Chu Chang, Genomic Health's vice president of business development, said in a statement.
Genomic Health developed its flagship breast cancer-recurrence test Oncotype DX on its own, and the Pfizer alliance presents the shop with an opportunity to expand its technology to indications that are interesting to deep-pocketed pharmaceutical partners.
Although the financial details of the collaboration were not released, collaborating with a pharmaceutical behemoth like Pfizer could benefit Genomic Health when it comes time to market the test and negotiate with payors.
Pfizer currently markets a drug, Sutent (sunitinib malate), a kinase inhibitor indicated for advanced renal-cell carcinoma. The company did not respond to requests for comment. However, by increasing its understanding of Stage I-III, localized, clear cell-type cancer, Pfizer might be able to develop more personalized drugs and treatment strategies for the indication.
If the collaboration yields a diagnostic, Genomic Health anticipates that a prognostic genomic assay will be commercially available by 2011.
However, since a renal cancer test would be based on the same technology platform as Oncotype DX, it remains unclear whether the product will be considered an in vitro diagnostic multivariate index assay, and if so, which regulatory pathway – 510(k) submission or a premarket approval – it would have to undergo.
There are still outstanding questions as to whether Oncotype DX – a predictive and prognostic test – will require FDA approval. Genomic Health officials have said they are waiting for the agency to release the final guidance on IVDMIAs before making a decision to take Oncotype DX through the FDA approval process [see PGx Reporter 08-08-2007
Medical devices may be designated to three risk-based classes – Class I having low risk, Class II being moderate risk, and Class III having high risk. The FDA’s draft guidance on IVDMIAs suggests that most of these kinds of tests will be Class II or Class III devices. Class II devices require a 510(k) premarket notification submission. Class III devices require premarket approval.
Confounding the issue is the fact that, in May, after the FDA cleared a breast cancer recurrence test made by Genomic Health rival Agendia, called MammaPrint, the agency issued a special controls guidance that conferred de facto Class II status to all breast cancer prognostic tests and absolved device makers from going through FDA’s more rigorous premarket approval process [see PGx Reporter 05-16-2007]. It is unclear if this regulatory distinction will hold for prognostic renal cancer tests.
Industry observers have noted that the advancement of pharmacogenomics and personalized treatments will require new business models in which small diagnostics shops leverage the marketing muscle of big pharma partners.
Pfizer has been a leading participant in this transition. Its non-exclusive collaboration with diagnostic maker Monogram is one example of a successful relationship between a drug and diagnostic company that led to an FDA-approved antiretroviral and companion diagnostic.
Pfizer “stands to gain insight into the biology of renal cell carcinoma, which may serve as a basis for improving decisions around therapeutic and pipeline development.”
Under that alliance, Monogram developed an assay called Trofile that helped determine which patients would best respond to Pfizer’s drug maraviroc. In turn, Pfizer markets the test to patients worldwide [see PGx Reporter 05-10-05].
In collaborating with Pfizer, Genomic Health might similarly benefit in terms of garnering market share in new indications and further increasing adoption of its technology. In turn, Pfizer could gain access to a clinically tested technology that is already the foundation for a widely used product.
According to Genomic Health, since Oncotype DX launched in early 2004, more than 6,600 physicians in the US have used it to help plan breast cancer treatment for 39,000 patients.
Genomic Health President Kim Popovits has previously said that more than half of all insured individuals in the US are now covered for Oncotype DX. During the quarter ended Sept. 30, 2007, the company signed reimbursement contracts with CareFirst Blue Cross Blue Shield, which insures 3.2 million people, and Blue Cross Blue Shield of Arizona, which insures 1.1 million. In addition, the company signed a contract with WellPoint to cover Oncotype DX with certain restrictions [see PGx Reporter 11-14-2007].
Yet despite Genomic Health’s success in driving the adoption of Oncotype DX, company officials have noted that reimbursement remains the main barrier to wider use of the test. In this regard, Pfizer’s negotiating power with insurance companies may help broaden reimbursement.
Because drug companies have become risk-averse in recent years, industry observers have noted their unwillingness to take on more uncertainty in their R&D pipeline by investing in new, and clinically unproven, technologies. In its decision to take the plunge with Genomic Health, Pfizer was likely enticed by the company’s technology, which has undergone extensive feasibility and validation studies for the Oncotype DX test.
“We will apply the same strategy used to develop Oncotype DX, which took almost four years to conduct feasibility studies, identify and refine the gene set, perform analytical and clinical validation, and commercialize,” the Genomic Health spokesperson said.
In addition to gaining access to a clinically useful test in an area of unmet medical need, Pfizer “stands to gain insight into the biology of renal cell carcinoma, which may serve as a basis for improving decisions around therapeutic and pipeline development,” the Genomic Health spokesperson said.