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.
Abbott Laboratories made plans to enter the cancer screening market with its reported acquisition of Exact Sciences Corp. The deal will pay Exact Sciences shareholders $105 per share in cash, a nearly 50% premium to Exact’s unaffected share price on Nov. 19. That represents a total equity value of approximately $21 billion and an estimated enterprise value of $23 billion.
Exact Sciences Corp. rolled out its multi-cancer early detection test nationwide to expand screening and identify malignancies when treatment has the greatest chance of being curative. Cancerguard can detect signals for cancers accounting for more than 80% of all cancer diagnoses in the U.S. each year.
The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.
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 approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
Guardant Health Inc.agreed to pay more than $900,000 to settle allegations that the company’s human resources office hired a relative and a friend of a physician who persuaded the company to make the hires in a quid pro quo for orders of Guardant’s tests. The U.S. Department of Justice said the penalties could have been much greater but for the company’s cooperation in the investigation, which disclosed that at least one of these hires was not qualified for the position.
The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance regarding adenoma, the advisory committee voted 6-3 that the benefits outweigh the risks in a decision the FDA is likely to affirm.
