Skip to main content
Premium Trial:

Request an Annual Quote

In Brief This Week: Cardio Diagnostics Holdings, Elypta, Sarepta Therapeutics, Kazia Therapeutics

NEW YORK –  Cardio Diagnostics Holdings (CDH) this week said it has partnered with Austin, Texas-based concierge and executive health practice RiverRock Medical, which will incorporate CDH's Epi+Gen CHD and PrecisionCHD epigenetic heart disease risk and detection tests into its offerings. As part of the agreement, CDH's tests will be available to all RiverRock Medical patients. In addition, the company's Actionable Clinical Intelligence platform, which connects DNA methylation and single nucleotide polymorphism biomarkers measured by these tests to coronary heart disease drivers, will be available to healthcare providers. 

Swedish early cancer detection company Elypta has received certification of its quality management system to the ISO 13485:2016 standard for medical devices, in adherence to current regulatory requirements specific to the medical device industry, the company said this week. Elypta is advancing a broad study program based on measuring glycosaminoglycans (GAGomes) across different cancers with the first indication expected to be early recurrence detection in renal cell carcinoma, the company said. 

Cambridge, Massachusetts-based Sarepta Therapeutics this week said it completed the sale of a Rare Pediatric Disease Priority Review Voucher, a voucher awarded as part of a Food and Drug Administration program to encourage sponsors developing therapies for rare pediatric diseases. The voucher can be redeemed by the awardee to receive priority review of a marketing application for a future product, sold or transferred. Sarepta said it will invest proceeds from the $102 million sale of the voucher, which the FDA awarded after the approval of Elevidys (delandistrogene moxeparvovec), into its R&D efforts. 

The US Food and Drug Administration this week granted fast-track designation to Kazia Therapeutics' PI3K/AKT/mTOR pathway inhibitor paxalisib for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy. The designation was based on data from the Phase I trial of paxalisib that showed responses in all nine evaluable patients with brain metastases in the trial. With fast-track designation, Kazia will be able to meet with the FDA more frequently to get advice on developing paxalisib, to submit data on a rolling basis, and to apply for accelerated approval or priority review. 

The US Food and Drug Administration this week granted breakthrough therapy designation to Merus' zenocutuzumab for patients with previously treated advanced non-small cell lung cancer whose tumors harbor NRG1 fusions. The FDA also granted breakthrough therapy designation to zenocutuzumab for NRG1 fusion-positive pancreatic cancer patients last month. The designation allows for more intensive and expedited communication between Merus and the FDA, including guidance on the path to a biologics license application. 

Guardant Health said this week that it has received national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, for its Guardant360 CDx liquid biopsy test for patients with advanced or metastatic solid tumors.  

The firm announced the ministry's initial regulatory approval of the Guardant360 CDx in March 2022, which recognized the assay as a companion test for identifying patients with microsatellite instability-high solid tumors who may benefit from Merck's checkpoint inhibitor Keytruda (pembrolizumab) and patients with MSI-high advanced colorectal cancer who may benefit from Bristol Myers Squibb's checkpoint inhibitor Opdivo (nivolumab). The MHLW also approved the test for identifying patients with metastatic non-small cell lung cancer who may benefit from Amgen's KRAS inhibitor Lumakras (sotorasib).  

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.