Roche has claimed the exclusive international rights to Freenome’s multiomic cancer screening approaches, toward the goal of developing blood testing kits for markets outside the U.S.
The licensing deal between the longtime partners includes Roche making a new $75 million equity investment in Freenome, plus commitments to support its R&D work. Including future milestone payments and royalties, the total value of the pact could top $200 million, according to the companies.
At the same time, Freenome’s researchers will get to toy with Roche’s new sequencing-by-expansion method for parsing DNA, known as SBX, which was unveiled this past February. The high-throughput technique combines elements of DNA synthesis and nanopore-based reading by amplifying the signal of each nucleotide base in the strand.
“This collaboration demonstrates our commitment to blood-based early cancer detection, which has the potential to transform disease management,” Roche Diagnostics CEO Matt Sause said in a statement. “Furthermore, it represents an example of our intent to establish high-impact clinical applications for our groundbreaking sequencing by expansion technology.”
Earlier this year, Freenome inked a U.S. licensing and commercialization agreement with Exact Sciences for its blood-based screening test for colorectal cancer, which is currently under premarket review by the FDA, with a decision expected in the second half of next year.
That deal is worth up to $885 million, all told—including $200 million linked to the agency’s approval, and $500 million more if it receives a high rating tied to insurer coverage by the U.S. Preventive Services Task Force—and aims to offer a simple alternative screening option to Exact Sciences’ Cologuard at-home stool DNA test.
But the test may find a new home next year under Abbott, after the major medtech announced this week its $23 billion plan to acquire Exact Sciences, in one of the largest M&A deals in diagnostics to date. On a call with investors, Abbott CEO Robert Ford said he sees Freenome’s colorectal cancer blood test not as a potential competitor to the Cologuard business, but as another way to expand the overall reach of cancer screening.
“From what I've seen, the introduction of blood tests has actually positively contributed to Cologuard’s growth rate—especially given the significant commercial infrastructure and coverage that they've got in this market,” Ford said. “So I actually see that as a [total addressable market-] expanding test, not necessarily a test that's going to take away from the momentum of Cologuard.”
Freenome’s agreement with Exact Sciences recently cleared an antitrust hurdle. Meanwhile, Freenome retained the rights to the test, known as SimpleScreen CRC, when it is ordered in the U.S. in combination with other screening tests, such as for lung cancer. And regarding its deal with Roche, for developing test kits to be used in clinics, Freenome is holding onto control of centralized lab testing for markets outside the U.S.
“We are delighted to deepen our R&D partnership with Roche to enhance our multiomic blood-based cancer screening platform and accelerate our test pipeline,” said Freenome CEO Aaron Elliott. “Combining our technology with Roche’s expertise in kit development and its footprint outside the United States will enable us to extend our reach globally and help more patients.”