Research & Development
Policy & Regulation
Trends & Finance
Policy and Regulation: Page 3
Natera’s Prospera Lung transplant assay approved for Medicare coverage
The test will be covered under the Medicare Local Coverage Determination for Molecular Testing for Solid Organ Allograft Rejection for use in the surveillance setting in lung transplant patients.
August 17, 2023
FDA tells consumers to trash tests from company involved in illicit lab scandal
The FDA is unable to confirm how well the tests perform and, as such, there are concerns that the products may not be safe and effective.
August 16, 2023
SEC investigating Illumina for Grail acquisition
The firm revealed in its quarterly SEC filing that it had received a letter last month informing it of the investigation, along with a request for documents and communications.
August 11, 2023
CareDx lands Medicare coverage for heart transplant surveillance testing
The testing service, branded HeartCare, features AlloMap Heart and AlloSure Heart, both of which have individual Medicare coverage.
August 9, 2023
OIG audit shows some IHS COVID-19 funds misused, recommendations issued
The OIG determined that the funds were misused – or not used before the funds expired – because the IHS did not provide clear guidance or oversight to the programs for the use of the funds or the accounting and tracking of these funds.
August 2, 2023
FDA awards EUA to Alphadera Labs’ COVID-19 test
Alphadera Labs received the EUA after evaluating its test on 60 clinical nasopharyngeal swabs specimens. ALPHADx provided the same results as a “highly sensitive” FDA-authorized molecular SARS-CoV-2 test.
August 2, 2023
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
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
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
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
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
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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