Exact Sciences and Freenome Collaborate to Challenge Guardant Health in Colorectal Cancer Screening Market

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Exact Sciences Bets on freenome’s blood Test to Bolster Cancer Screening Portfolio

By [Your Name/Archyde Staff] – October 26, 2024

Exact Sciences, a leading player in precision oncology, is making a significant move to strengthen its colorectal cancer screening offerings. The company has entered into an exclusive licensing agreement with privately-held Freenome, acquiring U.S. commercial rights to Freenome’s blood-based screening test, SimpleScreen. the deal, potentially worth up to $820 million, comes as Exact Sciences navigates a setback with its own internally developed blood test and seeks to stay competitive in a rapidly evolving market.

The move underscores the growing importance of non-invasive blood tests for early cancer detection. Exact Sciences’ existing precision oncology testing portfolio already generates considerable revenue – nearly $688 million in sales last year, according to its latest annual report. However, recent clinical trial results for its in-house blood screening test where disappointing, showing sensitivities of 73% for colorectal cancer and only 14% for advanced precancerous lesions, falling short of the thresholds needed for widespread Medicare coverage.

Freenome’s SimpleScreen offers a potential solution. The company recently completed submission of its pre-market submission to the FDA and is preparing a supplemental submission for a next-generation version of the test. The agreement grants Exact Sciences exclusive U.S. rights to both current and future iterations of the test specifically for colorectal cancer screening.

Strategic Play for Both Companies

This deal is a win-win. For Freenome, it provides crucial funding and a powerful commercialization partner in Exact Sciences. Importantly, Freenome retains the rights to incorporate colorectal cancer screening into a broader, multi-cancer early detection test currently under progress – a potentially massive market chance.

“This is a shot in the arm for Freenome,” noted Puneet Souda,an analyst at Leerink Partners. “It provides them with cash and an R&D partner while allowing them to maintain control of their multi-cancer early detection rights.”

For Exact Sciences, the agreement offers a promising alternative to its own struggling test and a chance to validate Freenome’s technology. Analysts predict a launch for the Freenome test is unlikely before late 2026, pending FDA approval, placing Exact Sciences roughly two years behind competitor guardant Health in the market. However, Souda believes the collaboration will bolster confidence in Exact Sciences’ broader pipeline of cancer screening assays.Deal Details: A Phased Approach

The financial terms of the agreement are structured around key milestones:

Upfront Payment: Exact Sciences will pay Freenome an undisclosed sum in cash by November 2024.
Milestone Payments:
$100 million upon frist-line FDA approval of the initial SimpleScreen test.
$100 million upon first-line FDA approval of the next-generation test, contingent on meeting pre-defined performance benchmarks.
$500 million if the test receives a Grade A or B advice from the U.S. Preventive Services Taskforce (USPSTF) or achieves favorable payer coverage.
Royalties: Freenome will receive royalties ranging from 0% to 10% based on the test’s profitability, with provisions to ensure commercial viability.
R&D Collaboration: Exact Sciences will invest $20 million over the next three years in joint research and development efforts leveraging freenome’s technology.

Exact Sciences retains the right to terminate the agreement if certain unspecified criteria are not met.

This deal highlights the intense competition and rapid innovation within the liquid biopsy and early cancer detection space. As technology advances,the promise of detecting cancer earlier and more effectively through simple blood tests is driving significant investment and strategic partnerships.

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How might Exact Sciences’ existing infrastructure benefit the commercialization of Freenome’s CRC screening test?

The Shifting Landscape of Colorectal Cancer Screening

The colorectal cancer (CRC) screening market is poised for significant disruption. For years, Guardant Health has largely dominated the liquid biopsy space with its shield test. However, a new alliance between Exact Sciences and Freenome is aiming to aggressively challenge that position, bringing innovative multi-cancer early detection (MCED) technology and established market reach together. This collaboration represents a pivotal moment in the evolution of non-invasive cancer detection.

Understanding the players: Exact Sciences, Freenome, and Guardant Health

Exact Sciences: Best known for Cologuard, a non-invasive stool DNA test for colorectal cancer, Exact Sciences has a robust infrastructure for test distribution, physician engagement, and patient access. Their existing network is a key asset in this new venture. They are heavily invested in early cancer detection and expanding their portfolio beyond just CRC.

Freenome: A privately held biotechnology company, Freenome specializes in developing blood-based tests for early cancer detection using a proprietary platform. Their technology focuses on identifying unique patterns of cell-free DNA (cfDNA) fragmentation, offering a potentially more sensitive and specific approach to liquid biopsy analysis.

Guardant Health: The current leader in liquid biopsy for cancer, Guardant Health’s Shield test is a widely adopted CRC screening option. their success stems from early market entry and a strong focus on minimal residual disease (MRD) monitoring and recurrence assessment.

The Collaboration: A Synergistic Approach

The partnership between exact sciences and Freenome centers around the development and commercialization of Freenome’s CRC screening test. Here’s a breakdown of the key aspects:

1. Technology Integration: Freenome’s advanced cfDNA analysis technology will be combined with Exact Sciences’ established clinical expertise and infrastructure.
2. Clinical Trials: The collaboration will accelerate ongoing clinical trials evaluating Freenome’s test, aiming for rapid regulatory approval. Data from the pivotal PRECISION trial is eagerly anticipated.
3. Commercialization Strategy: Exact Sciences will leverage its existing sales force and distribution network to bring the new test to market, potentially reaching a wider patient population than Freenome could independently.
4. Financial Terms: The agreement includes upfront payments, milestone-based payments, and royalties to Freenome, demonstrating exact sciences’ commitment to the partnership.

How Freenome’s Technology Differs: cfDNA Fragmentation Patterns

freenome’s core innovation lies in its ability to analyze the patterns of cfDNA fragmentation in the bloodstream. Unlike customary liquid biopsy approaches that focus on identifying specific mutations, Freenome’s technology looks at the shape of the DNA fragments.

Unique Fragmentation Profiles: Cancer cells release cfDNA with distinct fragmentation patterns compared to healthy cells.

Enhanced Sensitivity & specificity: this approach aims to improve both the sensitivity (detecting cancer when it’s present) and specificity (avoiding false positives) of CRC screening.

early Detection Potential: By identifying subtle changes in cfDNA fragmentation, Freenome’s test may be able to detect CRC at earlier stages, when treatment is more effective.

Impact on the Colorectal cancer Screening Market

This collaboration is expected to have a significant impact on the CRC screening market in several ways:

Increased Competition: The entry of a strong competitor will likely drive down prices and encourage innovation.

Expanded Access to Screening: Exact Sciences’ distribution network could make liquid biopsy screening more accessible to patients who are hesitant to undergo traditional colonoscopies.

Shift Towards Multi-Cancer Early Detection (MCED): Both Exact Sciences and Freenome have ambitions beyond CRC. This partnership could accelerate the development of MCED tests capable of detecting multiple cancers from a single blood draw.

Focus on Patient Compliance: Non-invasive screening options like liquid biopsies generally have higher patient compliance rates compared to colonoscopies, potentially leading to earlier diagnoses and improved outcomes.

The Role of Liquid Biopsy in Cancer Screening

Liquid biopsy is rapidly becoming a cornerstone of cancer management, offering a less invasive alternative to traditional tissue biopsies. Key benefits include:

Real-time Monitoring: Liquid biopsies can be used to monitor treatment response and detect recurrence.

Personalized Medicine: Analysis of cfDNA can help identify specific mutations that may guide treatment decisions.

Reduced Patient Burden: Blood draws are less invasive and more convenient than surgical biopsies.

Future Outlook: Beyond Colorectal Cancer

While the initial focus is on colorectal cancer, the long-term implications of this collaboration extend to the broader field of cancer early detection. Both companies are actively exploring the use of their technologies to develop tests for other cancers, including:

Lung Cancer

Breast Cancer

Pancreatic Cancer

The success of this partnership could pave the way for a future where routine blood tests can detect multiple cancers at their earliest, most treatable stages. The ongoing research and