BOGOTA, Colombia – Venezuela’s med-tech sector has been virtually decimated by the ongoing crisis, which has not only displaced millions of people but also destroyed the country’s economy over the past four years.
HONG KONG – South Korea’s Genomictree Co. Ltd. has said its U.S. branch, Promis Diagnostics Inc., based in Pasadena, Calif., gained $30.8 million in funds this month. The Daejeon-based company has secured $40.8 million for its U.S. subsidiary since founding it in August 2019.
The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.
The patent subject matter eligibility problem has rattled the world of diagnostics for several years, but the U.S. Senate has been silent about legislation in recent months. Patent attorney Michael Borella, of McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), said he does not expect Congress to provide any legislative fix to the problem any time soon.
Salt Lake City-based Co-Diagnostics Inc. has finished the principle design work for a polymerase chain reaction (PCR) screening test for the novel coronavirus that has sickened nearly 3,000 with an acute respiratory illness and killed more than 80 people in Wuhan, China.
Liquid biopsy startup Elypta AB has raised €6.1 million (US$6.72 million) in a late seed financing led by Industrifonden and Sciety. Norrsken Foundation’s newly launched €100 million “impact-first” fund also contributed to the round. The Stockholm-based company plans to use the money to complete development of laboratory kits and software for measurement and analysis of a panel of metabolites it has identified.
SANTA CLARA, Calif. – It has never been easy to get payers to reimburse in a timely and adequate fashion for novel diagnostics, making it notoriously difficult to build a business from them. But a few high-flying diagnostics companies, such as Madison, Wis.-based Exact Sciences Corp. and Redwood City, Calif.-based Guardant Health Inc., have been blazing the trail recently on how to rapidly scale up to become valuable commercial entities from origins as a research-based startup.
SANTA CLARA, Calif. – Just as it does with treatments, the National Comprehensive Cancer Network (NCCN) offers detailed guidelines on genomic testing by cancer type. These are key in determining what physicians can prescribe routinely and what insurers will cover. But those guidelines aren’t followed regularly outside a major research hospital setting, thereby obviating access to tumor genetic information that could help to better guide treatment. Even if current guidelines are followed, physicians and patients can get information back from the tests that neither party is prepared to process.
Unlike with other kinds of cancer, there’s no opportunity for a biopsy ahead of surgery for a suspected brain tumor. To help matters, researchers have developed a novel approach that combines a new, commercially available imaging technology – stimulated Raman histology (SRH) – with an artificial intelligence (AI) algorithm to offer a diagnosis of brain tumors in just a couple of minutes. They published the results of a study in the Jan. 6, 2020, issue of Nature Medicine that determined their approach was noninferior to standard pathologist interpretation of histologic images.