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.

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.

SAN FRANCISCO – After slowing growth starting in mid-2018 and a court battle with Boston Scientific Corp. that ended in a favorable resolution, 2019 was a much better year for pain neurostimulation player Nevro Corp., as it launched a major new product. So far, 2020 is looking up too. Its shares (NYSE:NVRO) gained 5% following a presentation at the J.P. Morgan (JPM) Healthcare Conference, where it preannounced 2019 revenues and offered 2020 guidance.

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.

SAN FRANCISCO – Investor confidence in Exact Sciences Corp. has started to stumble in recent months. The Madison, Wis.-based company’s valuation peaked at about $15.5 billion just a few short weeks after it announced that it would acquire Genomic Health Inc. in late July. Its market cap trajectory has been uneven since and took another hit when the company preannounced 2019 earnings at the J.P. Morgan (JPM) Healthcare Conference, falling to around $13.5 billion.

Device makers only can watch when cardiologists grapple with federal agency officials over device utilization. However, cardiologists are punching back hard against a rule used to judge whether a coronary artery stent is appropriately used, thus ensuring these devices won’t suffer a significant drop in utilization.

SAN FRANCISCO – Major genetic research efforts designed to encompass millions of people globally have been setting up their infrastructure in recent years to serve both researchers and patients. This work is being done by major national initiatives, such as All of Us in the U.S. and Genomics England in the U.K., as well as by health care systems such as Intermountain and Kaiser.

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.