#USA #Brisbane #Colorectal Cancer #Freenome #Exact Sciences

Freenome Partners with Exact Sciences: A New Era for Colorectal Cancer Screening

In an important strategic move for cancer detection, Freenome, a biotechnology firm noted for its innovative cancer screening technologies, has announced an exclusive license agreement with Exact Sciences. This collaboration is set to advance the commercialization of Freenome's blood-based screening test for colorectal cancer (CRC). The implications of this partnership could make significant strides in the fight against CRC, a leading cause of cancer-related deaths worldwide.

Background on the Agreement

This exclusive agreement includes U.S. commercial rights and Freenome's underlying technology for the CRC blood test, which provides a less invasive alternative to traditional colonoscopy methods. Freenome retains the rights to use its technology for other cancer types, allowing for a comprehensive suite of diagnostic tests aimed at early detection of various cancers. The agreement is poised to bring about a deal potentially worth up to $885 million, contingent on meeting specific regulatory and screening guideline milestones.

Accelerating Market Access

One of the key advantages of this partnership lies in Exact Sciences' established commercial infrastructure. They have access to nearly 400 health systems with integrated Electronic Medical Records (EMR), over 865 in-network payers, and a network of more than 260,000 ordering physicians. This network also includes millions of patients who are familiar with Cologuard®, a stool-based genetic test used to screen for colorectal cancer, thereby accelerating the market penetration of the new blood-based test.

CEO Aaron Elliott of Freenome emphasizes that this agreement represents a critical juncture in their mission to detect cancer during its most treatable stages. With this partnership, the blood test could be available to millions of patients sooner.

Milestones and Financial Implications

The financial structure of the deal is substantial. Freenome will receive an immediate upfront payment of $75 million, and there are additional milestone payments amounting to $200 million associated with the first-line approval of the test from the FDA. Success in achieving either an A or B rating for the test from the United States Preventive Services Taskforce could lead to an additional $500 million. It also includes royalties from test sales, projected to increase as gross margins reach certain targets, along with additional funding for joint Research and Development initiatives.

The Role of AI and Data

Freenome is not just stopping at colorectal cancer; they are augmenting their technology to utilize multimodal data from patients to enhance their artificial intelligence and machine learning models. This is vital as the company aims to improve its platform's effectiveness over time.

Riley Ennis, co-founder and Chief Product Officer at Freenome, outlines that this partnership is crucial for scaling their operations and improving early cancer detection across multiple types.

Performance Metrics and Efficacy

Freenome's CRC screening test has shown promising results. In trials involving nearly 49,000 average-risk adults, it detected 81.1% of colorectal cancer cases, along with a 90.4% specificity rate. These figures underscore the potential of Freenome's offerings in reducing the mortality rates associated with this condition, as early detection increases the survival rate significantly.

Future Aspirations

As Freenome advances its multiomics platform, the company's ultimate goal is to offer a comprehensive cancer early detection program. It aims to develop a common lab platform that tailors tests to individual patients based on their specific risk profiles.

By targeting not just those at high risk, but also those at average and elevated risk, Freenome is committed to making significant advancements in personalized cancer detection.

Conclusion

The collaboration between Freenome and Exact Sciences marks a pivotal moment in cancer screening technologies. With the new CRC blood test poised to enter the market, the partnership has the potential to revolutionize patient care by providing less invasive, more accessible screening options. As they push forward in this innovative space, both companies are set to make a substantial impact on cancer detection and treatment methodologies in the coming years.