Innovating with Inivata

BOULDER, Colo.—March saw the beginning of an international partnership aimed at helping cancer patients breathe a little easier, as Biodesix Inc. and Cambridge, U.K.-based Inivata, a clinical cancer genomics company focused on the potential of circulating tumor DNA analysis, joined forces for the development and commercialization of next-generation sequencing (NGS) blood-based tests for clinical applications in lung cancer. Per the terms of the agreement, Biodesix and Inivata will conduct studies leveraging the latter’s NGS technology platform in patients with non-small cell lung cancer (NSCLC). Though no specific financial details were disclosed, the two companies will jointly fund studies to determine the clinical utility for an NGS-based test, with plans to launch an observational study later in the year.

“The combination of our world-class blood-based sequencing technology with Biodesix’s ability to develop and establish diagnostics as standard of care creates a strong platform to develop new, highly clinically relevant tests,” Nitzan Rosenfeld, chief scientific officer at Inivata, commented in a news release. “We are excited to be working with Biodesix to improve the care offered to cancer patients.”

In this partnership, Biodesix and Inivata will utilize Inivata’s proprietary, enhanced TAm-Seq technology platform, along with Biodesix’ U.S. development and commercialization capabilities, to develop clinically actionable tests for physicians.

As Inivata notes on its website, “TAm-Seq is the first method to demonstrate reliable de-novo identification of rare cancer mutations by screening entire genomic exons in degraded or dilute[d] samples, such as circulating DNA of FFPE specimens.” This approach, the company adds, has potential in terms of “using circulating tumor DNA as a liquid biopsy to identify, non-invasively, genomic changes in a cancer” and as a “cost-effective method to monitor tumor burden over time using a blood test.”

“Approximately 30 percent of NSCLC patients are unable to obtain a biopsy or have insufficient tissue from a lung cancer biopsy to provide the diagnostic information needed for their care. Blood-based diagnostics can make a real difference in such cases. Using Inivata’s circulating tumor DNA analysis platform, we can now provide information that was previously unattainable for these patients, leading to better outcomes,” Inivata CEO Michael Stocum noted in a statement.

Diagnosis for this lung cancer generally happens late in life, with roughly two out of three people aged 65 or older when they receive their diagnosis; the average age at diagnosis, according to the American Cancer Society, is 70. In fact, less than 2 percent of all cases are found in individuals less than 45 years old, emphasizing the void new diagnostics could fill.

“Along with VeriStrat, a serum protein test that is already commercially available to help physicians guide treatment decisions for patients with advanced NSCLC, the blood-based NGS tests we’re developing with Inivata will further drive towards precision medicine by guiding diagnosis, prognosis and monitoring for patients with NSCLC,” added David Brunel, CEO of Biodesix.

Biodesix’s VeriStrat proteomic test is a blood test for patients with advanced NSCLC that provides a diagnosis by detecting certain proteins linked to the cancer. The company recently announced that a paper was published in Lung Cancer supporting that the test could improve overall survival and decrease medical costs, noting in a press release that “By shifting patients away from ineffective therapy, the use of VeriStrat resulted in improvement in overall survival as well as a total lifetime direct medical cost decrease of $135 per patient.” The test received CareFirst Blue Cross Blue Shield coverage in April for use as “a marker to aid in predicting patient response to EGFR-TKI drugs.”