The Food and Drug Administration (FDA) recently proposed a rule through the federal register that would require most clinical tests used in screening, diagnosis, and patient management to undergo pre-market review by the agency at the end of a five-year rollout. Previously, only commercial tests sold by companies to labs were required to undergo pre-market review; tests developed and used within the same lab, known as laboratory-developed tests (LDTs), have not been subject to review.
The Immune Deficiency Foundation submitted comments on the proposed rule urging FDA not to move forward as planned. Commercial test developers perceive rare disease tests with low volume and high cost as an impractical investment. As a result, many tests essential for the screening, diagnosis, and management of rare conditions like PI are currently available only as LDTs. IDF is concerned that the proposed rule as written will result in thousands of LDTs that have not been shown to pose harm no longer being offered—not because they would not pass pre-market review, but because the laboratories that currently offer them cannot afford and do not have the expertise to undertake the FDA’s pre-market review process.
