Freenome Holdings Inc. reported it is going public via a special purpose acquisition company. The company said it expects to raise $330 million, which it plans to use for the 2026 launch of its blood-based screening tests for multiple cancers. Backed by an affiliate of Perceptive Advisors - Perceptive Capital Solutions Corp. (PCSP) – and joined by RA Capital, the arrangement includes a commitment of $240 million in equity investments plus about $90 million more held by the SPAC’s trust fund. Other notable investors, including ADAR1 Capital, Bain Capital Life Sciences, and Farallon Capital Management have signed on to participate in the deal.
With an at least $60 billion total addressable market, the liquid biopsy sector offers abundant opportunity for multiple companies to swim to the top. The six largest companies in the pool have just dipped their toes in the water, with a total penetration of only 10%, a white paper from RBC indicates.
Exact Sciences Corp.’s Cologuard Plus received U.S. FDA pre-market approval as a non-invasive colorectal cancer home screening test. The next-generation, stool-based assay, developed in conjunction with the Mayo Clinic, reduces false positives by 30% compared to the original Cologuard test without diminishing its sensitivity for cancer or advanced adenomas.
Exact Sciences Corp. reported performance data for its blood-based colorectal cancer screening test that showed sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy.
The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.
Exact Sciences Corp. demonstrated a significant increase in accuracy with the latest version of its Cologuard test for colorectal cancer in its pivotal BLUE-C study. Top-line results released this week showed that the next-generation test exceeded the specificity and sensitivity seen in the DEEP-C study that underpinned U.S. FDA approval of the commercially available version of Cologuard, a stool-based assay.
Dxcover Ltd. raised $9.25 million (£7.5 million) in a series A fundraising round and received a grant of $2.7 million (£2.2 million) from the European Innovation Council to support development of the company’s liquid biopsy platform for the detection of multiple early-stage cancers. Existing investors Eos Advisory LLP, Mercia Asset Management plc, Scottish Enterprise, University of Strathclyde, SIS Ventures and Norcliffe Capital led the round, which was also joined by Mark Banforth of Thairm Bio.
Precisedx Inc.’s digital artificial intelligence (AI) platform better predicts the recurrence of early-stage breast cancer within six years than traditional testing, a study published in Breast Cancer Research found. Understanding which patients with early-stage disease face significant risk of their cancer returning is important for guiding selection of treatment. The system reduces the variability inherent in histological characterization and grading of breast cancer (BC) today, thereby improving prognostic accuracy.
Thirteen months after Illumina Inc. and Grail Inc. merged, prior to regulatory approval, the deal has taken a turn for the worse. The prognosis looked better following an administrative law judge’s ruling Sept. 1 against the U.S. Federal Trade Commission’s lawsuit seeking to block the transaction, but the European Commission (EC) issued a decision Sept. 6 prohibiting the deal based on the likelihood that a merger would stifle innovation and limit choices in the early cancer detection liquid biopsy market.
