The Surveillance Heartcare Outcomes Registry trial demonstrated that Caredx Inc.’s Heartcare test identifies acute cellular rejection in heart transplant patients better than donor-derived cell-free DNA (dd-cfDNA) alone, while reducing biopsies and improving clinical outcomes. Heartcare combines two non-invasive tests, dd-cfDNA and Allomap Heart gene-expression profiling.
The effects of U.S. Supreme Court case law on patents are well demonstrated, but the latest victims of patent jurisprudence are directed toward a critical need for desperately ill patients. The Court of Appeals for the Federal Circuit ruled that several claims found in three patents licensed to Caredx Inc., of Brisbane, Calif., are ineligible due to a purported lack of inventiveness under Section 101 of the Patent Act, an outcome that sustains what some believe is a trend in case law that is hostile toward diagnostic patents in the U.S.
Organ transplant diagnostic company Caredx Inc. has received CE marking for its Alloseq HCT chimerism testing kit and Alloseq HCT interpretation software for use in patients who have received hematopoietic cell transplantation (HCT). The NGS-based solution is used to monitor engraftment and evaluate the success of a hematopoietic stem cell transplant by measuring the relative ratio of the recipient and the donor cell population post-transplantation.
The U.S. Centers for Medicare & Medicaid Services (CMS) has decided to leave the onus on Medicare administrative contractors (MACs) to make coverage determinations regarding the Allomap test for heart transplant rejection despite a request for a non-coverage policy. As was the case in the decision to allow MACs to determine coverage for total artificial hearts, the CMS said that the low annual rate of utilization of the Allomap, by Caredx Inc., of Brisbane, Calif., suggested that the MACs are in a better position to make the appropriate call regarding coverage.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA’s cybersecurity discussion paper emerges; CMS eyes MAC default for Allomap coverage; CMS floats draft coverage for CRC screening test.
Brisbane, Calif.-based Caredx Inc., which is aiming to transplant patient outcomes, saw the presentation of a host of data at the recent American Transplant Congress annual meeting.
Brisbane, Calif.-based Caredx Inc. has reported a strategic alliance with Weill Cornell Medicine that makes the company the exclusive development and commercialization partner for Uromap, a urine-based gene-expression test for acute cellular rejection in kidney transplant recipients.
