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Significant extension of FDA regulatory oversight over certain “home brew” laboratory tests
September 25, 2006
FDA Alert

This alert discusses proposed FDA regulation of in vitro diagnostic multivariate index assays and the potential impact of this draft guidance, particularly on clinical laboratories, pharmaceutical and biotech companies.

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On September 7, 2006, the Food and Drug Administration (“FDA”) issued a draft guidance[1] (“guidance”) in which, for the first time, the agency exercised its authority to regulate certain in vitro diagnostic multivariate index assays (“IVDMIAs”) that are developed and manufactured by clinical laboratories (“laboratories”) for their own use (“home-brew tests”). The emergence and increased use of IVDMIAs using novel technology as an integral part of treatment or health-care decision-making for patients, and their subsequent direct advertisement to consumers, led the FDA to conclude that the current level of oversight over genetic testing by laboratories was inadequate, and could lead to significant issues related to the quality and validity of these devices.

The FDA is soliciting comments on this guidance. The comment period will remain open until December 6, 2006.

Background

An IVDMIA is a protein-based diagnostic laboratory assay or test that uses mathematical formulae to interpret gene and protein data needed to generate information used to make critical diagnosis and treatment decisions for patients with certain serious diseases. For FDA regulatory purposes, IVDMIAs are classified as medical devices. IVDMIAs developed and manufactured by commercial, non-laboratory-based companies are currently regulated by the FDA. Most IVDMIAs, however, are developed and manufactured by laboratories for their own use as home-brew tests.

Historically, the FDA had exercised its discretion not to regulate home-brew tests for two primary reasons. First, the laboratories are regulated under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).

The FDA felt the regulatory oversight over these laboratories exercised by the Centers for Medicare and Medicaid (“CMS”), the federal agency generally responsible for CLIA, ensured that the laboratories were competent to properly manufacture and use home-brew tests without additional intervention by the FDA. Second, the FDA was already reviewing the primary ingredients in the home-brew tests, and did not feel it necessary to regulate these assays further.

Draft guidance

The guidance provides for regulation of the IVDMIAs based on the intended use of the tests. It is anticipated that most IVDMIAs will be regulated as either Class II devices (requiring 510(k) clearance) or Class III devices (requiring the submission of a stringent and complex pre-market application seeking FDA approval). The requirement for FDA external validation, and the use of objective and consistently applied criteria by the FDA, is intended to provide an independent determination, now lacking, that an IVDMIA has both analytic and clinical validity. To be effective, accurate, and reliable, an IVDMIA must exhibit both (i) “analytic validity,” to establish that the test will consistently and correctly determine the presence of the particular gene mutation; and (ii) “clinical validity,” to establish that test results will correlate with the presence or absence of the targeted disease.

The guidance also requires laboratories that manufacture IVDMIAs to comply with the FDA quality system regulations (“QSRs”) applicable to the manufacture of medical devices, as well as other controls and requirements for regulated medical devices, including adverse event reporting.

Industry concerns

For an industry already wary of the FDA Office of In Vitro Diagnostic Device Evaluation and Safety, the office charged with oversight of IVDMIAs, the guidance has led to concerns that the requirements imposed on IVDMIAs will result in approval delays by the FDA, thereby inhibiting innovation and development. In addition, it is feared that the proposed pre-marketing and post-marketing regulation would add significantly to the costs of the tests, thereby limiting patient access.

Laboratories further voiced concern about dual regulation of the manufacture of IVDMIAs by both CMS and the FDA, and the impact on their operations of conflicting or competing requirements. The concern has been recognized by the FDA and a separate guidance in connection with QSR compliance for laboratories covered under both FDA and CLIA requirements will be issued.

The pharmaceutical industry will also be significantly affected by the regulatory changes to IVDMIA technology. According to recent pharmaceutical drug trend reports, during the next five to 10 years, about 10 to 20 percent of drugs in development will likely be associated with genetic tests. In addition, in the next three years, as many as seven products could be introduced with genetic or other biomarker information included in product labeling. Thus, regulatory changes to these home-brew tests may delay drug development and approvals, affect drug labeling, and ultimately affect treatment and advertising or promotional claims.

To manage possible increased costs, delays in product development, and labeling concerns, companies should evaluate and pay careful attention to how the FDA implements and enforces the guidance once it is finalized and effective. Toward that end, laboratories, device and pharmaceutical manufacturers, and others in the industry who use these clinical tests may want to seize the opportunity to provide comments to the FDA, to help shape a final guidance that balances public health risk and innovation fairly.


  1. “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays,” 71 Fed. Reg. 173, 52800 (Sept. 7, 2006).
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