FDA grants de novo for Biofire multianalyte assay

The FDA announced that it granted the de novo petition for the Biofire respiratory panel 2.1, for qualitative detection of both the SARS-CoV-2 virus and other respiratory pathogens using nasopharyngeal swabs. The agency simultaneously revoked an emergency use authorization for the multi-analyte test, which was issued in May 2020, and noted that this action renders the test eligible for marketing after the end of the COVID-19 pandemic. The study used to validate the test drew on more than 500 test samples and multiple analytical studies, a set of requirements the agency said exceeded those needed for EUAs. The grant creates a new product code (QOF) and a new regulation for the associated special controls (21 CFR, 866.3981). Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said the move “underscores the FDA’s ongoing commitment to expand access to testing while providing important safeguards through both our EUA authority and traditional review pathways.” The Biofire test is developed by Biofire Diagnostics LLC, of Salt Lake City.

No injuries or deaths associated with Acist Kodama recall

The FDA said the class I recall of the Kodama intravascular ultrasound catheter by Acist Medical Inc., of Eden Prairie, Minn., is due to the prospect that the catheter’s O-ring housing may compress and damage the O-ring during use. No complaints, injuries or deaths have been reported in connection with the problem, which could result in O-rings becoming lodged in the circulatory system and causing patient injury or death. The recall affects 490 units distributed between Nov. 10, 2020, and Jan. 14, 2021.

Supreme Court to hear assignor estoppel case

The U.S. Supreme Court has added the case of Minerva Surgical Inc. v. Hologic Inc. to the docket for an April 21 hearing that will examine the role of assignor estoppel in patent litigation after a patent has been assigned to another entity. This case was heard in the Court of Appeals for the Federal Circuit roughly one year ago, where the court agreed with a Delaware district court’s decision that the statute does not prevent an assignor from attempting to invalidate a patent via the inter partes review process. Hologic Inc. had acquired the two patents in question from the founder of Minerva Surgical Inc., and brought an infringement suit against Minerva in 2015, although one of the contested patents has since expired. Several intellectual property groups have filed friend-of-the-court briefs, including the Intellectual Property Owners Association, which said Supreme Court jurisprudence has lent little insight into the question. The association said the doctrine of assignor estoppel is limited in scope, but that the doctrine prevents companies from assigning a patent, and subsequently arguing the patent is of limited or no value.

Cardiac rehab bill resurfaces in U.S. House

A new bill has surfaced in the U.S. House of Representatives, H.R. 1956, the Increasing Access to Quality Cardiac Rehabilitation Care Act of 2021, which was introduced with bipartisan support and which would expand patient access to cardiac and pulmonary rehabilitation (CR/PR) programs in Medicare. The bill is in the jurisdiction of the House Energy and Commerce and the Ways and Means Committees, and resurrects a bill of the same name unveiled in 2019. The text of the bill was not available at press time, although American Heart Association CEO Nancy Brown responded with a March 18 statement. Brown said Congress “took a major step in 2018 when it included provisions in the Bipartisan Budget Act that authorized physician assistants, nurse practitioners and clinical nurse specialists, referred to as advanced practice providers (APPs), to begin supervising patients’ day-to-day CR/PR. This bill would move the effective date of those provisions to 2022 from 2024, bringing the benefits of these services to more patients sooner,” Brown said. H.R. 1956 would also ease the wait times typically experienced by those seeking cardiac rehab.