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.
Intuitive Surgical Inc. more than gave back all its 2020 share price gains thus far, dipping almost 4% on earnings news. Over the past few years, its valuation (NASDAQ:ISRG) repeatedly has climbed, only to later retrench and then rise again to a slightly higher peak.
The 2.3% tax on medical devices is a thing of the past. Now, Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), has revealed to BioWorld that the supporters of the Affordable Care Act (ACA) saw the tax as little more than “a spreadsheet exercise” in financing the more costly elements of the legislation.
SANTA CLARA, Calif. – While many of the presentations at the Precision Medicine World Conference revolved around clinical studies and their promise for future breakthroughs in health care, a continuous stream of companies made their pitches for translating these studies into actual products that can benefit patients now.
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.
SANTA CLARA, Calif. – Peter Thiel is not a fan of incremental science. The high-profile venture capital investor, who invests across technology and the life sciences via various vehicles, including the Founders Fund, suggested that as academic and government bureaucracies have scaled up and rigidified over the last 50 or 60 years, that has eroded the ability of researchers to pursue innovative science.
Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
Remember how Ras is a frequently mutated oncogene in solid tumors? Well, it turns out Ras plays a role in those memories, too. In the Jan. 13, 2020, online issue of the Proceedings of the National Academy of Sciences, scientists at the Scripps Research Institute in Juniper, Fla., reported on the discovery that Ras signals through Raf and then Rho kinase to control whether memory is short- or long-term.