The US Food and Drug Administration announced its final rule for regulating lab-developed tests on 29 April, marking the launch of a new era of in vitro diagnostics. Notably, the agency’s final rule provides a broader-than-expected exemption for LDTs already on the market as of 6 May, the scheduled date for publication in the Federal Register, while…
The Food and Drug Administration has finalized a divisive plan to regulate laboratory medical tests — including some used to diagnose cancer and Alzheimer’s disease — over concerns about reliability and risks to patients. The agency says inaccurate results may force patients to unnecessarily start a new treatment or delay care. Federal officials maintain that granting…
President Joe Biden is scrambling to fund his cancer moonshot and its ambitious goal of cutting the death rate by half — an aim close to his heart that’s no longer a bipartisan priority. Lawmakers backed the initiative during the final days of Barack Obama’s presidency, passing the 21st Century Cures Act, and allotting $1.8 billion…
Francis S. Collins, MD, PhD, a renowned physician-geneticist and former director of the NIH, revealed he has prostate cancer. In a perspective piece published in the Washington Postopens in a new tab or window, Collins said he went public to “share lifesaving information, and I want all men to benefit from the medical research to…
Abstract: Congress passed legislation on March 22 that cut funding for the NIH and NCI through the remainder of fiscal year 2024. Members of the cancer community want funding levels for these agencies to be restored during the next budget go-round. Fiscal year 2025 begins on October 1. Advocates hope funding levels are restored in…
The Biden administration is facing a looming deadline in the next few months to finalize key health care rules. If agencies take too long to finish regulations on minimum staffing levels at nursing homes, discrimination and abortion data protections, a ban on menthol cigarettes and others still in the pipeline, they could all disappear next…
On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” In the wake of repeated congressional inaction on the Verifying Accurate Leading-edge IVCT Development Act or the “VALID Act” (S. 2209/H.R. 2369), which would establish a…
With the US Food and Drug Administration (FDA) likely in coming weeks to release its final rule on regulation of laboratory-developed tests (LDTs), Congress has indicated interest in once again taking up oversight of such tests and reforming diagnostics regulation. This month, US Sen. Bill Cassidy, R-La., issued a Request for Information (RFI) asking stakeholders for input…
Creating a regulatory framework for laboratory-developed tests shouldn’t be as complicated as the tests themselves. But months after Congress failed to advance legislation that would have established that framework — and with the FDA’s final rule on LDT regulation set to drop — lawmakers on the Hill continue to debate the issue, with many arguing…
The VALID Act and the regulation of diagnostic tests resurfaced at a House Energy and Commerce hearing today that coincided with the FDA finalizing a rule that would give it oversight for four years. The big picture: Trade groups mostly supported Congress taking action on oversight of the tests, with some explicitly endorsing the VALID…
