Detecting an Opportunity in EXACT Sciences

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On Monday, EXACT Sciences (Nasdaq: EXAS) reported flat year-over-year quarterly revenue of $1.2 million and a net quarterly loss that decreased to $1.9 million ($0.07 per share), compared to a net loss of $4.2 million ($0.16 per share) for the same quarter last year. This revenue was primarily from amortization of up-front license fees from LabCorp (NYSE: LH), with the remainder coming from royalties on LabCorp's sales of colorectal cancer screening test PreGen-Plus and sales of Effipure units to LabCorp.

However -- aside from encouraging cost-cutting by EXACT, which gives the company adequate liquidity for about two years -- the real potential here lies in two upcoming catalysts within the next few months. The first catalyst will occur at the upcoming Digestive Disease Weekly conference being held from May 19-24, at which EXACT will present encouraging data from two clinical trials. These trials showed higher sensitivity (88%) for the company's latest version of its DNA-based colorectal screening test; they also showed positive results in the detection of inflammatory bowel disease.

The second, most important, catalyst for EXACT will occur in late spring, when an updated guidelines decision is expected from the U.S. Multi-Society Task Force, which includes the American Cancer Society. If EXACT receives an endorsement of its stool-based DNA technology in the revised colorectal cancer screening guidelines, it will mark a major milestone for the company, allowing it to increase sales of its test exponentially, since third-party payers use these guidelines for their reimbursement decisions.

The CEO of EXACT, Don Hardison, best summarizes the opportunity in the company's earnings release by saying the following: "If our non-invasive screening technology secures this important endorsement, we will be poised to execute on a focused campaign to obtain reimbursement from payers, a major step toward commercial success. We intend to direct our efforts primarily toward the Centers for Medicare and Medicaid Services to obtain reimbursement for Medicare beneficiaries as well as other large payers."

Investors may soon share this enthusiasm for shares of EXACT -- which have languished in the past six years since their debut at more than $14 per share -- if the long-awaited and often-delayed update to colorectal screening guidelines finally includes the company's stool-based DNA technology.

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Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives and works in the small Pennsylvania town of Portage. He invites your comments and feedback. Mike does not have a position in any company mentioned. The Fool has a disclosure policy.