But as the worst of the pandemic appears to have passed, discussion of blood shortages has increasingly drawn on the vocabulary of commerce, and the warnings about the blood supply have been rife with references to supply chain problems that go beyond the need for more donations.
That’s the consensus in the blood banking community, in line with a longstanding conviction that volunteer donations should remain at the blood system’s core. Read More »Īugust 2022-Blood is a precious resource and shouldn’t be treated as a commodity. In response, the FDA expressed concern about the public harm, and the reference laboratory pulled the test from the market. Patient advocacy groups had raised a concern because several women had undergone unnecessary prophylactic bilateral oophorectomy based on this LDT. Regulatory oversight of LDTs has been in active discussion since 2008 when the FDA intervened with a national reference laboratory that was selling a test that had been developed at a prestigious university to identify high-risk women who might have ovarian cancer. If you have not followed this bill and the issues of LDT oversight, allow me to offer some context. I have heard from some pathologists and laboratorians who are concerned about this legislation and about the CAP position on it since the Senate HELP Committee released a draft on May 17, 2022.
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As I write this, the VALID Act has been voted out of a Senate committee and now awaits further action by the full Senate. September 2022-Like so many pathologists, I have been keeping a close eye on the VALID Act, which would create a new framework for FDA oversight of laboratory-developed tests (LDTs). If you’re arguing for your patient that this is the biomarker that makes them eligible for the drug, then the next questions will be, What was the number? And what was the test?” And it’s off to the races. “It’s not the only way in, but it’s one of the ways in. “That doesn’t sound too controversial, right?” says Alain Borczuk, MD, vice chair of anatomic pathology and director of oncologic pathology, Northwell Health Cancer Institute. In mid-2020 the FDA approved pembrolizumab as a new treatment option in adult and pediatric patients with TMB-high (≥10 mutations/megabase) solid tumors, as determined by the FDA-approved FoundationOne CDx assay. That story is playing out again in the realm of measuring tumor mutational burden.
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September 2022-It may not be the oldest story in the world, but in clinical laboratories it’s an oft-told tale: Tumor meets biomarker drug meets companion diagnostic both meet FDA approval clinicians meet with patients offering new hope-and those in the lab are left trying to figure out how to make it all work.
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