SANTA ANA – Irvine-based Agendia complains that while it spent huge amounts of time, energy and resources to gain formal approval from U.S. Food and Drug Administration for its breast-cancer test, its chief rival, Genomic Health Inc., has chosen to bypass federal regulation.
FDA approval is not required for laboratory-developed tests such as Mammaprint and Oncotype DX. However, the lack of direct regulation is a “recognized problem” that the FDA is seeking to address, said Alberto Gutierrez, head of the agency’s office of In Vitro Diagnostics and Radiological Devices. He said the FDA has drafted guidelines that would require FDA approval for these tests and, if approved, they could be adopted “in the near future.”
FDA oversight, and the periodic inspections that go with it, means Agendia is constrained in what it can do and say while Genomic Health is not subject to similar limitations, says Agendia’s CEO, David Macdonald. “What they consider evidence would likely not pass muster with the FDA,” he fumes.
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Neil Barth, Agendia’s chief medical officer, said that when the company took a “two-year hiatus” from 2005 to 2007 in order to get up to speed with the FDA, it “lost tremendous momentum and market share.” It gambled that FDA approval would give it superior standing in the oncology market and drive sales. “But unfortunately it has not yielded the benefit we had hoped for,” Barth conceded.
In Genomic Health’s view, the FDA is hardly the ultimate arbiter of safety and effectiveness — especially in a global marketplace. It notes that Oncotype has been endorsed over Mammaprint by some very respectable organizations, including the prominent biannual St. Gallen Breast Cancer Conference in Switzerland and the UK’s National Institute for Health and Clinical Excellence, which selects treatments and procedures that are eligible for reimbursement by that country’s financially strapped government-run health system.
Nor are Agendia’s hands as tightly bound as it likes to claim, contends Steven Shak, Genomic Health’s chief medical officer. He noted that Agendia says it not only predicts the likelihood of metastasis but also can help determine the optimal treatment in the early stage of the cancer. The FDA, however, has said specifically that Mammaprint is not intended to “predict or detect response to therapy, or to select the optimal therapy for patients.”
Agendia says Mammaprint’s value in helping doctors decide the best course of treatment is in conjunction with two of its complementary tests. Some oncologists say that the tests, when used together, give them valuable information.
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