A Diagnostics & Imaging Week

The Coalition for 21st Century Medicine (Washington) said Tuesday that it "strongly opposes" a citizen petition filed by Genentech (South San Francisco, California) earlier this month, seeking to restrict the ability of laboratories to offer diagnostic tests to physicians and patients.

The organization said the company's request "threatens innovation in laboratory tests, would harm patient care and rests on flawed scientific and legal premises."

Saying it "represents some of the world's most innovative diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists, and patient advocacy groups," the coalition describes its mission as "to encourage the research, development, and commercialization of innovative diagnostic techniques."

It said that in contrast, the Genentech petition, by requesting that the FDA approve all laboratory tests, "would delay the introduction of many critically needed diagnostic tests, and prevent others from ever being available."

Further, said the coalition's statement, "although implied to be narrow, the petition is sweeping in scope. Genentech maintains that the Food and Drug Administration (FDA) should regulate all laboratory developed tests (LDTs) "for use in drug or biologic therapeutic decision making."

The coalition noted that LDTs "are developed precisely for the purpose of helping physicians make therapeutic decisions for their patients, including the decision of which drug to prescribe. The overwhelming majority of LDTs fall within the scope of the petition."

In its statement, the coalition said Genentech's citizen petition "relies on several incorrect assumptions."

It said one of the most "fundamental errors" is that FDA review and approval is needed for all LDTs used in therapeutic decision–making "to ensure that claims made for the tests are scientifically proven."

The coalition statement said Genentech "wrongly asserts" that FDA approval is a prerequisite for claims to be considered "scientifically proven." It said "FDA approval is not needed for a LDT's performance to be demonstrated. There are many other methods of establishing a LDT's performance, such as the publication of reproducible research findings in peer–reviewed publications."

It added, "In seeking to require FDA approval of all LDTs used to make therapeutic decisions, Genentech relies on statements which it alleges are 'unsubstantiated' relating to LDTs affecting usage of its own products."

The coalition said there is a "vast difference between not knowing how much data support a particular claim, and whether the claim is actually unsubstantiated. A lack of information about some LDTs does not justify a revolutionary change in the regulatory regime for laboratories."

Moreover, it said, imposing FDA regulation is not needed to redress false or misleading claims. "The Federal Trade Commission has jurisdiction over that type of misconduct, as do the existing state agencies that regulate laboratories. Concerns about allegedly inaccurate statements can be readily –– and efficiently –– addressed within the existing regulatory framework," the coalition said.

It added that the Genentech petition "entirely ignores that a rigorous, well–established regulatory system already exists for LDTs. Laboratories and their tests need to meet the demanding requirements under the Clinical Laboratory Improvement Amendments (CLIA). They are also regulated by various states, as well as professional societies. Superimposing FDA approval of LDTs on top of the existing regulatory requirements would result in redundant – and even conflicting – regulation."

The coalition said overturning the existing regulatory regime for LDTs "would impose huge costs on laboratories. Even when a company possesses the data necessary to obtain FDA approval, companies still incur huge regulatory costs – and delays – in navigating the FDA approval process."

Clinical Data (Newton, Massachusetts) had said earlier that it also intends to oppose a the Genentech petition. Clinical Data said that genetic biomarker–based tests, including its own PGxPredict tests to assist in predicting a patient's response to specific drugs, have been developed according to current regulatory requirements and are performed in strict compliance with the Clinical Laboratory Improvement Amendments (CLIA). It said that the development and use of these tests are based on sound scientific evidence, and provide demonstrable clinical value in aiding physicians and patients in making more informed treatment decisions.

Clinical Data says it also endorses a degree of regulation that is necessary and sufficient. In contrast, it says that the position advocated by Genentech ignores the fact that excessive or inappropriate regulation is a disincentive to the development of innovative healthcare products that improve outcomes while lowering healthcare costs.