Guesstimates aren't good enough when diagnosing a deadly cancer, so Exact Sciences aims for accuracy. The firm develops non-invasive tests for the early detection of colorectal cancer and precancerous lesions. Its products isolate DNA in stool samples, using its Effipure technology, then identify genetic mutations associated with cancer. Colorectal cancer is a common (and one of the deadliest) cancers, and Exact believes its method is superior to existing diagnostic methods because it may be able to discern colorectal cancer in its early stages, when it is most treatable. However, facing several product development setbacks, the company is undergoing a strategic reorganization.
In 2008 the company announced that it would pursue strategic alternatives including a possible merger or sale. To reduce costs in the interim, Exact laid off about two-thirds of its employees.
A "strategic alternative" came along in early 2009 in the form of an offer of $41 million for the firm from SEQUENOM, which wanted to add Exact's products to its cancer testing lineup. Exact's board rejected the offer, but SEQUENOM then attempted to go ahead with a hostile tender offer. To better defend itself, Exact sold some intellectual property and a block of shares to Genzyme for $24.5 million. As a strategic move, it brought in much needed capital and allowed the company to retain important rights to other technologies. It also prompted SEQUENOM to cancel its exchange offer for Exact's shares.
The company's PreGen-Plus product was launched commercially in 2003 and was offered exclusively through testing service provider LabCorp. However, the product suffered a significant setback in 2007 when the FDA defined PreGen-Plus as a medical device and required additional regulatory clearance for its continued commercial distribution, and Exact began negotiating with the FDA to arrive at a solution. In the meantime, in 2008 LabCorp dropped PreGen-Plus from its test services, but continued to use part of Exact's technology in another colorectal cancer screening tool.
The company had been working on a second version of PreGen-Plus that it believed would be even more sensitive to the presence of colorectal cancer and precancerous lesions; Exact planned to submit the second version to the FDA in hopes of obtaining approval, but the company halted the product's development shortly after LabCorp announced its new product launch based on Exact's technology. At the same time, the company announced its strategic review of operations.
Exact had also been developing its genomics-based technology to detect other cancers.
In 2009 the company entered into a research and development collaboration with the that culminated in the development of the Cologuard marker panel that will be used in Exact's DeeP-C clinical trial and commercialized if approved by the FDA. The collaboration was expanded in 2012 to include all gastrointestinal cancers and diseases and new cancer screening applications of stool- and blood-based testing, again with Exact retaining exclusive rights to commercialize any resulting breakthroughs by paying up-front, milestone, and royalty payments to Mayo Clinic. – less