NEW YORK – 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).
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.
PBD Biotech said this week that it has begun a new clinical trial for its Actiphage TB molecular diagnostic test in partnership with the University of Leicester and the National Institute for Health and Care Research Respiratory Biomedical Research Centre in Leicester. It will be the largest clinical trial for the assay with more than 100 patients, building on a prior study in which it detected Mycobacterium tuberculosis in the blood of naïve pulmonary TB patients with a sensitivity of 73 percent and specificity of 100 percent, PBD said. The new study will assess the test's performance against the World Health Organization minimum reference target product profile thresholds of 75 percent sensitivity and 80 percent specificity for a community TB triage test. Actiphage TB combines phage-induced lysis of infectious bacteria and molecular detection of bacterial DNA.
Thermo Fisher Scientific said this week that it has "entered into a definitive agreement" to acquire real-world data intelligence company CorEvitas from Audax Private Equity for $912.5 million in cash. Based in Waltham, Massachusetts, CorEvitas has approximately 300 employees and is "well positioned to grow its revenue organically in the low double digits, with expected revenue of $110 million in 2023," according to Thermo Fisher.
Thermo Fisher said the acquisition is expected to be completed by the end of 2023, subject to customary closing conditions, including regulatory approvals. Upon completion, CorEvitas will become part of Thermo Fisher's laboratory products and biopharma services segment. The transaction is expected to be immediately accretive to adjusted earnings per share by $.03 in 2024, Thermo Fisher noted.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.