Colon cancer. Cancer attacking cell. Colon disease concept
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Freenome has announced $254M of new funding, led by Roche but with multiple other firms participating, to advance the company’s pipeline of single- and multiple-cancer early detection tests built on a multiomics platform. The company’s lead programs are for colorectal and lung cancer screening. 

The early cancer detection market is valued at just under $1B now, but expected to grow substantially over the next decade as this is a high area of unmet need and a very competitive field.

“Enabling wider access to early cancer screening means helping patients receive timely information that can lead to better outcomes. Freenome’s groundbreaking blood-based screening and data-driven insights offer incredible potential to transform personalized healthcare,” said Matt Sause, chief executive officer of Roche Diagnostics.

Early detection is a key factor in cancer. Freenome’s multiomics platform uses computational biology, machine learning, and other technologies to develop screening tools to detect cancer in its earliest, most treatable stages. The platform is also being evaluated, with Freenome’s biopharma and diagnostic company partners, to non-invasively detect minimal residual disease.

“We look forward to collaborating with Freenome to advance the potential of their breakthrough multiomics technology for multi-cancer screening, building on our other initiatives to advance liquid biopsy innovations in cancer screening and minimal residual disease testing,” said Mark A. Gardner, senior vice president, molecular genomics and oncology, of Quest Diagnostics.

Freenome’s initial programs are focused on colorectal and lung cancer with a pipeline of single-cancer and multi-cancer tests under development. The company has two registrational studies underway: 

  1. PREEMPT CRC is a >40,000-participant prospective clinical study with comprehensive longitudinal real-world data (RWD) evaluating Freenome’s blood-based screening test among adults at average risk for colorectal cancer.
  2. PROACT LUNG is a prospective observational clinical study enrolling up to 20,000 participants. The study aims to validate Freenome’s lung screening test in current and former smokers 50 years and older who are eligible for screening with an LDCT scan.

These are key targets for early detection tests.

According to the World Health Organization (WHO), colorectal cancer is the third most common cancer worldwide, accounting for approximately 10 percent of all cancer cases and is the second leading cause of cancer-related deaths across the globe. While colonoscopy and fecal tests are available for this cancer, many people skip them.

Lung cancer is the leading cause of global cancer incidence and mortality, accounting for an estimated two million diagnoses and 1.8 million deaths per year.  

Freenome also has research programs to develop tests for detecting multiple cancers, including the Vallania Study. Combined, the company’s multiple-cancer studies will involve >10,000 participants with paired RWD. 

The Vallania Study is a multicenter, multiple-cancer, research program with more than 6,200 participants enrolled, including risk-matched control participants. The study will compare blood samples from both patients with cancer and without the disease to understand patterns associated with lung and other cancers.

“With this financing, we are well positioned to realize the full potential of our platform in delivering tests for early cancer detection,” said Mike Nolan, chief executive officer of Freenome.

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