The US FDA is establishing a new regulatory process for developers of NGS-based Lab-Developed Tests (LDTs) for cancer. On November 15, the FDA greenlighted IMPACT, an in vitro diagnostic test developed at the Memorial Sloan Kettering Cancer Center that uses NGS to screen hundreds of genes to detect the presence of cancer tumors. Along with the approval, the FDA also formed a new pathway for approving these types of tests.

The revamped process will be less burdensome and will make it simpler for developers to obtain 510(k) clearance, which is how the Agency assesses whether a product is equivalent to those already on the market. The announcement is less about revising the FDA’s stance on the need for standards for NGS-based testing and more about aiding developers that want their tests to be cleared, with the Agency creating a less complicated process for developers to indicate that the test has met those standards.

The approval of IMPACT is unlikely to affect the two draft guidances released by the FDA last July regarding the regulation of NGS tests, with an Agency spokesperson stating that the IMPACT authorization is separate from the FDA’s efforts on NGS draft guidances. The “one-test, one-disease model” of FDA regulations is unable to adequately assess NGS tests, because they have the capability to analyze millions of DNA variants in a single run. However, with the establishment of this precedent, it is possible that tests that include class II devices such as IMPACT may be able to obtain 501(k) clearance in the future.

Source: Bloomberg BNA