NEW YORK – Oncocyte, thus far a cancer molecular diagnostics company, said this week that it has shifted its plans for the organ transplant detection technology it acquired along with Chronix Biomedical in April. Instead of seeking a buyer for the platform, Oncocyte will now commercialize it, focusing on the European market.
Oncocyte intends to launch the test as an LDT in the first half of 2022 with selected partners in Europe. Simultaneously, the firm is looking for an instrument partner to support development of digital PCR kits for disseminated IVD use, with the intention of submitting for regulatory approval by late 2022.
During a call discussing the firm's Q2 financial results, Oncocyte CEO Ron Andrews said that the Chronix acquisition was initially driven by the opportunity the firm's technology provided for an entry into blood-based cancer monitoring.
Oncocyte has said it will bring Chronix's Therasure CNI assay, now renamed DetermaCNI, to market later this year. The test analyzes cell-free DNA from a blood sample, quantifying changes in copy number alteration that the company has previously shown can indicate response or lack thereof to cancer immunotherapy.
Although oncology drug response monitoring has become a major target for cell-free DNA technology, Chronix initially developed its underlying technology for transplant rejection, advancing an assay in Europe prior to its acquisition by Oncocyte.
According to Andrews, the initial post-merger plan had been to stick to oncology and offload IP related to this transplantation application to another firm. However, Oncocyte has reconsidered based on "feedback from the market" and a growing understanding of the differentiated nature of the Chronix technology, Andrews noted.
An example of such evidence, he said, is a recent coverage policy for noninvasive molecular transplant rejection testing issued by US Centers for Medicare and Medicaid Services contractor Palmetto GBA, which cites several scientific publications featuring the Chronix technology — something Andrews called a "huge validation."
"The Chronix data presented to date shows distinctly that donor-derived DNA monitoring using digital PCR can [detect] … injuries before clinical manifestation. This allows treatment of acute rejection and other causes of graft injury, which have the potential to significantly improve organ transplant outcomes in patients," Andrews said.
According to Andrews, the plan to keep this arm of the business in Europe, at least initially, reflects Oncocyte's desire to "stay focused" in the US on oncology product development: growing adoption of its DetermaRx assay for lung cancer therapy guidance, its DetermaIO immunotherapy response predictor, and the Chronix-developed DetermaCNI for therapy response monitoring.
Andrews estimated the total available market for the transplant rejection assay in Europe to be approximately $1 billion.
"We believe there's a pent-up demand based on our discussions with key opinion leaders and Chronix has done a really nice job of fostering relationships with some of the top transplant centers in Europe, who have seemed to be extremely interested," Andrews said.
In this new market, Oncocyte would compete with companies like Eurofins Viracor, CareDx, and Natera, which have also advanced cfDNA-based transplant rejection tests.
But Andrews said he believes adopting a kitted strategy should help Oncocyte compete with existing assays. "Being able to do it on site will significantly improve the turnaround time, which as we're hearing from [the market] is the real critical attribute of our test versus other assays that are being offered in Europe."
Oncocyte is aiming to secure a partnership for digital PCR kit development in the fourth quarter of this year, hoping to quickly begin the necessary studies to support IVD regulatory approval.
Several firms, including Bio-Rad, Thermo Fisher Scientific, and Roche, "have indicated interest," Andrews said.
Because Chronix has already conducted numerous studies of the assay, the remaining work will mostly focus on cross-validating whatever PCR technology the company chooses to existing performance benchmarks.
"We feel pretty confident that we'll be able to have a kitted product dossier ready to submit for IVDR, which is the European version of the FDA by late 2022," Andrews said.
"We have a head start given Chronix's European IP and work to date with key opinion leaders who are interested in working with us to bring the test to fruition," he said. "We've already begun the process of standing up a separate business unit … and, given the concentrated network of transplant centers in the EU and our approach of using established molecular labs, we do not expect it to significantly increase our quarterly burn," he added.
Future plans for the transplantation test in the US market are still open, Andrews said, but Oncocyte's current expectation is that it will wait till it has developed a kit product for the European market and then bring that to the US, where it would be differentiated from existing LDTs.