Policy and Regulation: Page 2

FDA starts one-year pilot program to tackle risks of lab developed oncology tests
The goal is to provide laboratories with information to support development of LDTs for specific cancer biomarkers, to facilitate “better and more consistent” testing and, by extension, “better drug selection and improved care for patients with cancer."
July 21, 2023
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Co-Diagnostics penalized by SEC for COVID-19 test claims, failing to disclose hiring of relatives
The SEC has filed a cease-and-desist order and fined Co-Diagnostics $250,000 due to allegations that the firm filed misleading press releases about its COVID-19 tests and not disclosing financial transactions involving the family members of executives.
July 10, 2023
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FDA authorizes Discover Labs to run molecular COVID-19 test at its Texas facility
Under the terms of the EUA, Discover Labs can run the COVID-19 test at its CLIA-certified Austin facility. The test is for prescription use only.
July 7, 2023
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FTC mulls changes to company merger rules
The proposed rule change would amend the Hart-Scott-Rodino (HSR) form and instructions, the first time in 45 years that the agencies will perform a top-to-bottom review of the form.
June 29, 2023
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Roche receives FDA clearance for test to accelerate diagnosis of Alzheimer’s
The new 510(k) clearance covers two tests that run on Roche’s Elecsys immunoassay system. One of the assays, which measures beta-amyloid, was part of the 510(k) clearance that Roche received last year.
June 29, 2023
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President Biden launches $50M initiative to improve cancer outcomes in low-income areas
The award creates five Centers for Cancer Control Research in Persistent Poverty Areas to advance key priorities of the Administration’s Cancer Moonshot.
June 26, 2023
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Report shows Medicare risked up to $888M in improper payments for molecular pathology test
The HHS Office of Inspector General analyzed Medicare Part B claims associated with payments for more than 450,000 genetic tests billed under Current Procedural Terminology (CPT) code 81408.
June 23, 2023
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With pilot program, FDA seeks to reduce risks of LDTs that identify cancer biomarkers
The agency said it has become increasingly concerned that some companion diagnostic tests made by laboratories that it has not authorized may not provide accurate and reliable test results.
June 20, 2023
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Seegene obtains IVDR certification for 30 diagnostic assays
The newly certified assays include eight for gastrointestinal infections, seven for women's diseases, five for respiratory diseases, four for tuberculosis, three for meningitis, two for human papillomavirus (HPV), and one for drug resistance.
June 1, 2023
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Advocacy groups in letter urge FDA to develop regulations for lab-developed tests
The FDA should use its authority to develop laboratory-developed test regulations if Congress does not pass legislation requiring it, said the Center for Science in the Public Interest and other organizations.
June 1, 2023
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FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults
Paxlovid is the fourth drug — and first antiviral pill — approved by the FDA to treat COVID-19 in adults.
May 25, 2023
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Industry organizations urge Congress to protect access to laboratory tests
In a letter to Congress, provider organizations make the case that without congressional action, Medicare reimbursement cuts could jeopardize access to many clinical laboratory tests.
May 22, 2023
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