NEW YORK (GenomeWeb) – Molecular diagnostics firm Biodesix plans this year to launch a proteomic test for guiding immunotherapy in non-small cell lung cancer patients as it continues to build out its lung cancer offerings.
The company aims to release the test around mid-year, said Gary Pestano, vice president of product development and operations, and will offer it for NSCLC patients who Biodesix's Veristrat test identifies as unlikely to respond to treatment with an EGFR inhibitor.
The addition is part of Biodesix's larger strategy to develop tests for multiple decision points along the treatment course of a typical NSCLC patient, in hopes that this will make the company's tests more attractive to clinicians than they would be offered alone. The company has branded its portfolio of multi-omic blood-based tests its "Lung Reflex" product.
Launched in 2009, Veristrat uses patient proteomic profiles generated by MALDI mass spec to determine whether or not a person is likely to respond to EGFR inhibitors, and is the company's first and flagship product. In 2015, Biodesix moved into the genomics space with the launch of its GeneStrat assay, a PCR-based test using BioRad's droplet digital PCR platform to identify clinically actionable mutations in free tumor nucleic acid. The initial version of the test looked at the EGFR, KRAS, ALK, and BRAF genes and the company has since added testing for ROS1 and RET mutations and EML4-ALK fusions.
The company intended for the PCR test to help it gain entrée with oncologists who would then, presumably, use Veristrat for their patients with wildtype or indeterminate results to determine if they were good candidates for an EGFR inhibitor. In 2014 the National Comprehensive Cancer Network approved inclusion of the test in its guidelines for NSCLC, recommending that it be used to determine whether patients with wild-type or unknown EGFR status should receive Genentech's Tarceva (erlotinib) as a second-line treatment.
Pestano said that the question has remained, however, of how to proceed with patients who test as Veristrat "poor," meaning they are unlikely to benefit from EGFR inhibitors.
"You do a GeneStrat test and get the EGFR results, and then if you are EGFR wildtype you go on to get a Veristrat test," he said. "And then the question has always been from the physician, 'What do I do when I get a poor?'"
The rise of cancer immunotherapies presents a possible option, and one Biodesix aims to address with its release this year, Pestano said. Like Veristrat, the immunotherapy test is MALDI mass spec-based but was developed using the company's newest discovery platform, which Pestano said use more powerful MALDI mass specs capable of going deeper into the proteome as well as improved informatics.
The immunotherapy test will be the first product developed on this new platform to come to market, Pestano said, adding that Biodesix has presented proof-of-concept work done on the platform as well as research looking at immunotherapy in melanoma.
At the Society for Immunotherapy of Cancer 2016 annual meeting the company presented two studies which assessed the ability of its proteomic technology to identify melanoma patients likely to respond to Bristol-Myers Squibb's programmed death 1 (PD-1) checkpoint inhibitor nivolumab (Opdivo); to predict progression-free survival of melanoma patients after HD IL-2 therapy; and to identify patients who might benefit from combinations of immune-checkpoint inhibitors.
The studies found that patients classified as group one fared similarly whether on monotherapy or multiple checkpoint inhibitor therapies, while patients classified as group two had better outcomes when treated with the nivolumab and ipilimumab combination, suggesting that the test is able to identify patients who will benefit from combination therapy.
Biodesix began its immunotherapy research in melanoma due to the availability of patient cohorts and more advanced nature of immunotherapy work in this cancer type, Pestano said, but, he noted, lung cancer remains the company's focus. The company is also working on an RNA-based test for measuring PD-L1, which is also predictive of some immunotherapies.
With the addition of the genetic assays and the forthcoming immunotherapy tests, Biodesix aims to "really cement Veristrat into [the NSCLC] testing paradigm," Pestano said.
"The reason we initially entered into the [genetic] space is that a lot of people were doing other people's tests for EGFR and then not ordering [Veristrat]," he said. "So we were losing those patients."
At the American Association for Cancer Research annual meeting this week in Washington DC, Biodesix presented data on the GeneStrat test's utility in the community setting, looking at results from roughly 4,000 patients and finding that the company was able to return results on 98 percent of the tests submitted and with a turnaround time of 72 hours or less for 95 percent of tests. Of the tested patients, 9 percent were positive for EGFR sensitizing variants, 9 percent positive for EGFR resistance, 11 percent for KRAS variants, and 1 percent for BRAF variants.
The company also reported at AACR on the development of process of the recent ROS1, RET, and EML4-ALK fusion additions to the GeneStrat test. It noted that it had established clinical specificity of 100 percent, respectively, for the 11 and eight ROS1 and RET variants the test measures, thought it has not calculated sensitivity for the assays, due to, the company said, "unavailability of samples with these rare mutations." It also assessed the performance of the EML4-ALK assay, comparing results to known positives and negatives as established by FISH and PCR. This portion of the test showed 85 percent sensitivity, 100 percent specificity, and 92 percent concordance with results from established assays.
As a private company, Biodesix does not release Veristrat sales figures, but in interviews last year, company officials said that more than 65 percent of GeneStrat orders are accompanied by a Veristrat order and that it had seen an uptick in Veristrat sales since launching GeneStrat.
Getting Veristrat orders from patients who use an outside company's assay for EGFR mutation testing continues to be a challenge for the company, though, and a potentially significant limitation given that GeneStrat competes with EGFR tests from much larger companies including firms like Roche and Thermo Fisher.
"We don't get a great many single Veristrats where the EGFR tests happen somewhere else," Pestano said.