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.

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.

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.

The U.S. Supreme Court has declined to hear the case of Athena v. Mayo, which many hoped would ease the patent subject matter eligibility problem. This outcome leaves Congress and the Court of Appeals for the Federal Circuit as the only likely sources of resolution for the problem, but there is skepticism as to whether either of these parties is both willing and able to overcome the impasse.

LONDON – Cognetivity Neurosciences Ltd. has received CE software as a medical device approval for its cognitive assessment tool, a five-minute test intended as a diagnostic aid to identifying the earliest stages of dementia.