From routine blood draws, Freenome’s diagnostic technology finds biological and genetic signs of cancer that can then be detected by currently available tests. A pivotal clinical trial of the company’s liquid biopsy technology is underway for the treatment of colorectal cancer.As Freenome envisions the potential to bring the test to market and expand its technology to other types of cancer, it now has $290 million investment From global pharmaceutical and diagnostic giant Roche.
Mike Nolan, chief executive of Freenome, said Roche brought not just money, but experience and expertise. Roche can help Freenome develop plans to add more cancers to its testing menu. He explained that the Swiss multinational can also assist with regulatory and commercialization plans in other markets around the world.
“Roche has been a board observer since the Series B [round of funding in 2019], so they know the company very well,” said Nolan, a veteran of Roche and its cancer genomics analysis subsidiary, Foundation Medicine. “Now we’re going to be more specific and specific about what we’re going to do. It gives us the opportunity to do more in the context of work, not just where we are not as invested as we are now. “
There are several players in the liquid biopsy segment of the diagnostics market, but South San Francisco-based Freenome is taking a different tack. Grail, which was reacquired by Illumina last year, commercialized a test that can detect more than 50 types of cancer by analyzing patient blood samples. Thrive Early Detection, now a subsidiary of Exact Sciences, is also developing liquid biopsy technology that can detect a variety of cancers from blood samples. Both companies use machine learning techniques for cancer analysis.
Like its competitors, Freenome also uses machine learning, aiming to eventually provide a blood test that can detect many types of cancer. But the company’s primary focus is colorectal cancer. One reason for this attention, Nolan said, is need.Colorectal cancer is Third leading cause of cancer death In the United States, according to the American Cancer Society.Last year, the Society updated colorectal cancer screening Guidelines, lowering the recommended age from 50 to 45. The change was made because of rising rates of colorectal cancer among young adults.
“The market has gotten bigger,” Nolan said. “The problem is that we’re not necessarily more effective at screening for colorectal cancer.”
The focus on colorectal cancer should allow Freenome to quickly commercialize its test, Nolan said. The health care system has determined which patient groups are eligible for colorectal cancer screening, who ordered the tests, and how the tests will be reimbursed. With these pathways in place, the test should be adopted quickly once it hits the market, Nolan said. Validation and establishment of the Freenome test in colorectal cancer should allow smooth expansion of the technology to other types of cancer, he added.
The ongoing pivotal test for colorectal cancer is expected to enroll more than 30,000 people. While there is already an FDA-approved colorectal cancer blood cancer screening test, Epi proColon, marketed by Germany’s Epigenomics, the regulatory pathway for the Freenome test is premarket approval. Preliminary data on the colorectal cancer test is expected early next year, Nolan said. Meanwhile, Freenome is preparing clinical trials for its diagnosis in as many as 10 other types of cancer. These tests may include breast, lung and pancreatic cancer.
The Roche investment announced on Tuesday follows $300 million in Series D financing Funds that closed last December. Roche is also part of the financing. Freenome is well-capitalized for clinical use, Nolan said. While there are no immediate plans for an IPO, Nolan said the company is looking at it as an option.
“As long as we remain focused on our mission to patients, then we’ll be able to raise money in the public or private markets,” he said. “But we want to be able to give us a public option.”
Photo: harmpeti, Getty Images
