NEW YORK(GenomeWeb) – Biodesix said this week that it has entered a partnership with UK-based genomics firm Inivata to develop and commercialize a next-generation sequencing-based blood test for clinical use in lung cancer.
The two companies are still in the early days of determining what intended uses to pursue under the collaboration, Biodesix CEO David Brunel told GenomeWeb. He cited as likely potential directions development of tests for guiding therapy in late-stage patients who have exhausted conventional treatment plans and support of drug development efforts.
The agreement further firms up Biodesix's move into the genomics space, which it first gestured toward at the beginning of this year with the announcement that it planned to launch a droplet-based digital PCR test for measuring three genes – BRAF, KRAS, and EGFR – in the plasma of lung cancer patients, and that it was working with a partner on NGS-based applications.
A spin-out of Cancer ResearchUK, Inivata's NGS work is based on its tagged-amplicon deep sequencing (TAm-Seq) technology, which combines target amplification with NGS to measure circulating tumor DNA in blood samples.
While Biodesix aims through the collaboration to bring NGS-based clinical diagnostics to the lung cancer market, the company sees these products as best suited for aiding treatment of late-stage patients, Brunel said.
"We don't think the panels are particularly useful to replace EGFR, EML-ALK, and BRAF testing," in first-line patients, he said. "You have clinically actionable mutations that are well known, so you want to focus on those. Why use a $6,000 [NGS] test when you can use a $600 test."
"Where [NGS panels] are most interesting is in the triage setting where you are in fourth-line lung cancer and you have blown through a lot of therapies and you are kind of at the point where you don't know what to do," Brunel said. "That is a good time to use a panel to look broadly for mutations which may be actionable."
Such tests could also be useful for monitoring later-stage patients, he added, noting that they could allow physicians to identify new mutations and respond with therapeutic changes more quickly.
Regardless, Brunel said, Biodesix's work with Inivata is still in the research stage, with much of the partners' focus currently on determining what the clinical utility of NGS in lung cancer might be.
To this end, the companies plan to start an observational trial this year.
Additionally, Biodesix aims to bring NGS into pharma collaboration work, Brunel said.
While much of the company's work thus far has focused on establishing the usefulness of its Veristrat proteomic test for guiding treatment of non-small cell lung cancer patients with small molecule EGFR inhibitors like Genentech's Tarceva (erlotinib), Biodesix has recently begun to focus on applying its technology to immunotherapies.
In 2012, the company presented data on a proteomic signature that helped identify pancreatic cancer patients likely to respond to GlobeImmune's GI-4000 immunotherapy.
And, this week Brunel said that Biodesix hopes to use Inivata's NGS capabilities to flesh out its offerings in this regard.
"Immontherapies are coming to market," he said, noting the approval by the US Food and Drug Administration last week of Bristol-Myers Squibb's lung cancer immunotherapeutic Opdivo (nivolumab). "And we are seeing that single markers are not sufficient to identify patients who are benefitting from receiving these drugs."
"So I think [by] broadening our offerings [to include genomics] and going to pharmas and saying, 'We have a commercial infrastructure, we can take these different technologies, and we can create a test that will be useful for guiding your therapy,' we are becoming a better partner," Brunel said.
Biodesix's move into genomics marks something of a shift from the trend of proteomics companies in recent years to focus primarily on commercialization of a single test with a narrow, well-defined intended use – a trend that was itself a response to the more diffuse, occasionally grandiose, commercial goals put forth by many proteomic diagnostic firms in the early days of the field.
In this regard, the company's plan calls to mind a similar shift from fellow diagnostics firm Vermillion, which, while not moving into genomics as yet, has recently announced its intention of expanding beyond proteomics.
Last year, for instance, Vermillion Chairman, President, and CEO James LaFrance said that the company plans to "expand beyond biomarkers and pure diagnostic measurement to include other modalities such as imaging, clinical risk factors, and patient data" in its testing.
Whether these moves represent a broader trend among proteomic diagnostic companies or merely an effort by a limited number of firms to diversify their capabilities remains to be seen.
In the case of Biodesix, though, the company is clearly pursuing opportunities beyond proteomics. To an extent, said Paul Beresford, vice president of business development and strategic marketing, this comes in response to requests from customers of its proteomic Veristrat test, which uses MALDI-TOF mass spec and a set of proprietary algorithms to predict response to therapy in lung cancer patients.
"From folks that are currently ordering Veristrat, it is very clear that there are a number of unmet clinical questions that need to be addressed across the continuum of care in lung cancer," he told GenomeWeb.
In addition to its NGS work with Inivata, Biodesix will next month launch its PCR-based GeneStrat test for measuring BRAF, KRAS, and EGFR mutations in first-line NSCLC patients.
Aimed at patients who are unable to get a biopsy for traditional immunohistochemistry testing, the test will also offer improved turnaround time – 72 hours compared to 10 to 14 days for conventional IHC – Brunel said.
Biodesix also continues to prepare a new version of its Veristrat lung cancer test for submission to the FDA for premarket approval as part of its ongoing partnership with drugmaker Aveo Oncology.
Last year, the two parties entered an agreement to co-develop and commercialize ficlatuzumab with a version of Veristrat as a companion test to predict best responders.
Under the terms of the agreement, Biodesix will fund the first $15 million of the drug development effort with the expenses thereafter split evenly between the two firms. The two will split any profits from commercialization of the drug. Additionally, Biodesix is solely responsible for all development of Veristrat, including taking the test through US Food and Drug Administration clearance or approval, and the company will retain all revenues from sales of the test.
Brunel said that Biodesix has begun clinical trials for the new test and has several interactions with the FDA planned for this year.