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.
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.
SAN FRANCISCO – Guardant Health Inc. has set the standard for liquid biopsy. That success has catapulted the Redwood City, Calif.-based company from an IPO in the fall of 2018 to a current valuation in excess of $7 billion. It has made its name – and much of its revenue – with its Guardant360 test, a molecular diagnostic test that assesses 74 cancer-related genes from the circulating tumor DNA to aid in designing the best treatment for advanced cancer patients with solid tumors.
Two players in the gene sequencing space, Illumina Inc. and Pacific Biosciences, have scotched their planned $1.2 billion merger roughly two weeks after the U.S. Federal Trade Commission posted a 5-0 vote to seek an injunction against the merger.
Menlo Park, Calif.-based Akoya Biosciences Inc. has scooped up $50 million in financing, with an eye toward growing via the expansion of commercial and operational resources and continuing product development activities around its platforms for spatial biology.
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy.
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
There have been three oncology drug approvals by the U.S. FDA over the last few years that were based solely on a genetic biomarker, rather than the location in the body where the tumor originated. But to make that tissue-agnostic approach a reality for oncology patients, detecting those genetic biomarkers will have to become increasingly easy and standardized.
LONDON – Monitoring low-density lipoprotein cholesterol (LDL-C) levels in patients with coronary heart disease (CHD) fails to identify those who are at highest risk for heart attack or death, according to a new study that used alternative biomarkers to assess the risk of further events.