A new survey by the Personalized Medicine Coalition (PMC) finds the current environment for having the Food and Drug Administration (FDA) regulate laboratory-developed tests (LDTx) is divided at best. The survey, “Pathways For Oversight,” noted that the FDA does intervene on occasion and regulate specific LDTs but that it is far from developing a systematic review process.
According to the 32-page survey, the FDA’s Center for Devices and Radiological Health only reliably intervenes in the development of LDTs if they are considered a companion diagnostic or biologic that requires the agency’s premarket review. However, it tends to be conservative in exercising such authority: In 2007, it declined to intervene in LabCorp’s development with Exact Sciences Corp. an assay for colorectal screening because it appeared Exact Sciences had provided LabCorp with instructions on how to perform the assay, along with specifications for test equipment.
Although the PMC is not advocating for either side of the issue, Amy Miller, the organization’s vice president of public policy, suggested the continued development of molecular-based tests that drive how medicines are prescribed may move the agency toward taking concrete action. “Personalized medicine is making drastic changes in how medicine is practiced, and there have been a lot of voices that molecular diagnostics are being used in unforeseen ways,” she said. “There are strong voices that a drug that required FDA-approval that a physician who helps select or avoid due to a test means the tests should be under more scrutiny.”
Miller also noted that if health insurers start requiring molecular tests be FDA-approved before authorizing their use for enrollees, it will prod more labs to seek agency approval for their LDTs. At the same time, the industry is expressing many of the same concerns expressed by biotech firms: FDA regulation is overly burdensome and stifles innovation.
That is among the reasons laboratory and medical device advocates and lobbies are split on the issue but leaning against FDA oversight. The Association for Molecular Pathology, American Clinical Laboratory Association, and College of American Pathologists all are calling primarily for enhanced regulation of LDTs from within the Clinical Laboratory Improvement Amendments.
Should the FDA need to provide oversight, it should be targeted and based on the risk posed to a patient by a malfunctioning test, according to CAP’s position. The Advanced Medical Technology Association wants FDA oversight of LDTs when appropriate, but the organization also believes it should be based on risk.
Meanwhile, Miller observed that several companies are either systematically seeking FDA approval for their tests or working in conjunction with medical device manufacturers as part of their approval process.
She noted that Qiagen, the German assay developer with operations in both Germany and Florida, seeks FDA approval for all of its testing kits, even though they mostly are considered LDTs. Several other firms are also seeking FDA approvals for their tests, she added. “They believe it gives them a market advantage.”
And not all LDTs slog through the FDA approval process. Miller noted that Pfizer’s development of the lung cancer drug Xalkori and a companion test by Abbott Molecular received approval in a relatively swift 18 months. “They worked together and got it done pretty quickly,” she said.
