The U.S. Federal Trade Commission announced Nov. 21 that it has obtained a civil monetary penalty in the amount of $700,000 from CRI Genetics LLC, an enforcement action taken under the agency’s policy for biometrics information.
Pacific Biosciences Inc. and Genedx Inc. reported a research collaboration with the University of Washington to study HiFi long-read whole genome sequencing’s (WGS) capacity to boost diagnostic rates in pediatric patients with genetic disorders.
The U.S. Office of Inspector General (OIG) has concluded an analysis that found fault with Medicare payments for genetic testing under CPT code 81408, a code that covers tests for a variety of mutations of medical interest. According to OIG, these claims were often paid $2,000 each despite poor oversight from Medicare administrative contractors (MACs), raising the risk that a substantial percentage of roughly $888 million in claims paid between 2018 and 2021 were either fraudulent or at best inappropriate.
The American College of Cardiology and the American Heart Association (AHA) released new guidelines for the diagnosis and management of aortic disease just ahead of this year’s AHA Scientific Sessions, which start Nov. 5 in Chicago. The update is the first comprehensive revision to the guidelines since 2010. Key recommendations address screening and diagnostic testing, imaging, patient involvement in care decisions and when to consider surgery.
Genetic testing has the potential to identify infants and children with autism potentially years earlier than clinical assessments, improving response to therapies and long-term outcomes. Sema4 Holdings Corp. presented results of a study Oct. 13 at the Child Neurology Society Annual Meeting that showed exome sequencing improved the diagnosis of autism spectrum disorders by up to 21% compared to current methods. At the same time, the research suggested that exome sequencing can identify children at risk of common comorbidities such as epilepsy, enabling more timely interventions.
Guardant Health Inc. expanded its cancer testing to include one that provides multi-dimensional insights into tumor profiles and microenvironment that can be used to guide therapy selection. The liquid biopsy, Guardantinfinity, combines analysis of more than 800 genes with exome-wide methylation detection.
The U.K. NHS is implementing the use of Oxford, U.K.-based Genincode plc’s predictive genetic test for patients suffering with hypercholesterolemia and familial hypercholesterolemia (FH). The Academic Health Science Network for the North East and North Cumbria (AHSN NENC) is adopting the Lipid Incode test in Darlington following a successful pilot study which demonstrated the test can detect and diagnose people with high cholesterol, a known risk factor for the development of cardiovascular disease (CVD). It is the first commercial polygenic test for CVD to be implemented by the NHS.
The FDA’s device center issued a safety communication advising that non-invasive genetic prenatal screening tests that are used to establish whether a fetus has a genetic abnormality can yield incorrect results. The problem stems in part from the fact that the agency has not yet reviewed any such tests, which are often administered as lab-developed tests (LDTs).
