PERTH, Australia – As of Feb. 12, Australia’s Department of Health confirmed 15 cases of novel coronavirus in Australia (five in Queensland, four in New South Wales, four in Victoria and two in South Australia). Of the confirmed 15 cases, five people have recovered and the others are in stable condition.
HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV diagnostic device. From sampling to testing, the device is apparently able to detect the novel coronavirus in just 40 minutes. In comparison, the polymerase chain reaction (PCR) technology that is currently in use can take between 1.5 to 3 hours. The device draws on the latest microfluidic chip technology from Shenzhen Shineway Hi-Tech Co. Ltd.
The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution.
IDbyDNA Inc., a San Francisco-based metagenomics technology company, scooped up $20 million in series B financing in a round led by Artis Ventures. Genesys Capital and others participated in the round. The company plans to use the money to accelerate uptake of its Explify software platform.
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.
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.