Commonly used tests to predict disease or match a cancer patient with the drug most likely to work will be more strictly regulated under a U.S. Food and Drug Administration proposal.
The plan released yesterday means the agency will review in advance all tests for genetic mutations that help doctors and their patients choose the best treatment options. For example, actress Angelina Jolie said she used Myriad Genetics Inc. (MYGN:US)’s screens for a gene defect in breast cancer to help her decide to undergo a double mastectomy after learning she carried a mutation associated with a high risk of the disease.
Myriad’s tests and those from companies including Quest Diagnostics Inc. (DGX:US) and Laboratory Corporation of America Holdings (LH:US), while widely used by doctors, don’t have FDA approval. As such laboratory developed tests have grown more complex and carry greater consequences, the FDA is seeking a larger role, Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, said in a blog post.
“Today, many LDTs are more complex, have a nationwide reach and have higher-risk uses such as detection of risk for breast cancer and Alzheimer’s disease,” Shuren wrote. “Without appropriate safeguards, neither patients nor their health care providers can be assured that these tests are safe and effective.”
The FDA has been authorized to review medical diagnostics since 1976, according to Shuren. Until now, it largely opted not to regulate laboratory developed tests, under what it calls “enforcement discretion.” The agency will continue this approach with screenings in individual laboratories in hospitals and clinics.
The FDA has found evidence of faulty lab tests including ones that cause people to be over- or under-treated for heart disease, cancer patients to get inappropriate therapy and children to be incorrectly diagnosed with autism, FDA Commissioner Margaret Hamburg said on a call with reporters.
The FDA notified Congress of the agency’s intention to regulate the lab tests. The notification is required 60 days before the agency issues its draft guidelines to do so.
Medical device manufacturers have pushed for the increased oversight while labs claim it will stifle innovation.
Labs must meet standards enforced by the U.S. Centers for Medicare and Medicaid Services, the American Clinical Laboratory Association said in a statement. Those standards should be updated “rather than impose an additional layer of regulation based upon a different statute designed for manufactured products rather than laboratory testing,” the lab group said.
Five Senate Democrats wrote the White House Office of Management and Budget on July 2 urging it to release the draft guideline after it “languished” there “for years.” Representative Louise Slaughter, a New York Democrat, wrote the office a year ago as well with the same request.
Some drugs come with FDA-approved paired tests already, which are called companion diagnostics, including Pfizer Inc. (PFE:US)’s Xalkori for a rare form of lung cancer and Roche Holding AG (ROG)’s Zelboraf for a life-threatening form of skin cancer. Xalkori’s and Zelboraf’s tests are made by diagnostics units of Abbott Laboratories (ABT:US), a device manufacturer, and Roche, respectively.
Salt Lake City-based Myriad has sought approval of its test for use with AstraZeneca Plc (AZN)’s olaparib for ovarian cancer. Myriad is a diagnostics company that is a lab approved by the Centers for Medicare and Medicaid Services.
The FDA’s regulation of the lab tests will be based on how much risk they carry. Shuren said the agency plans to phase in enforcement of premarket review and adverse event reporting requirements for high- and moderate-risk tests. Tests that perform the same function as FDA-approved companion diagnostics are considered among the highest-risk tests and will be the first required to gain FDA approval before they can be marketed, the agency said.
Tests on the market will have at least a year to comply with review requirements once the agency finalizes the proposal, Shuren said on a call with reporters.
Myriad is studying the agency’s proposal and “until our thorough review is completed, it is premature to comment further,” the company said in a statement.
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