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EXACT Sciences (NASDAQ:EXAS): Back On Track, Report Available
By: Mike Havrilla   Wednesday, July 15, 2009 9:18 AM

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EXACT Sciences (NASDAQ: ) provides a timely case study on the current debate over healthcare reform in the U.S. Our current "sick-care" system focuses on the treatment of disease rather than preventative medicine initiatives through investments in wellness programs and improved diagnostic screening tests - particularly in the area of cancer screening since this represents a fast-growing, costly disease.

The Company's next-generation screening test (V3) for colorectal cancer (CRC) holds the promise to detect both early-stage cancer and pre-cancerous growths. This stool-based DNA (sDNA) screening technology platform also has the potential to develop tests in the future for the early-stage detection of related cancers (e.g. stomach, pancreas, etc.). Rather than spending thousands on expensive treatments for patients with late-stage CRC; the focus of healthcare reform should be in the development of improved screening tests that will result in the detection of both pre-cancerous lesions and early-stage disease.

On 6/11/09, EXAS announced a collaboration and licensing agreement with the Mayo Clinic along with the closing of an $8.2 million (M) private placement for 4.3M shares of its common stock (with XMS Capital Partners serving as the Company's financial advisor). Including the newly-issued shares as part of the private placement, EXAS has about 35M shares of common stock outstanding for a market cap of about $95M as of mid-July with a stock price around $2.70 per share.

The pact with the Mayo Clinic is focused on developing patient-friendly diagnostics that reduce deaths from CRC. According to projections by the American Cancer Society (ACS) there will be 146,970 new cases of CRC and nearly 50,000 deaths attributable to the disease in 2009 in the U.S. alone, representing the second most common cause of cancer-related death following lung cancer (60,000 deaths) and ahead of breast cancer (about 41,000 deaths).

Under the license agreement, EXAS has secured exclusive rights to intellectual property (IP) developed by David Ahlquist, M.D., Mayo Clinic, including patents that cover advances in sample processing, analytical testing and data analysis associated with non-invasive, sDNA screening for CRC. EXAS will make up-front, milestone, and royalty payments to the Mayo Clinic and will provide funding for future work in Dr. Ahlquist's lab in exchange for the exclusive rights to commercialize any promising results from this collaboration.

A week after the Mayo Clinic deal, EXAS announced that it received a $1M loan from the Wisconsin Department of Commerce to relocate its headquarters and operations from Marlborough, MA, to Madison, WI. The Company's expansion plans include the creation of up to 150 jobs over five years as EXAS achieves commercial milestones for its non-invasive sDNA screening test for the early detection of CRC. The relocation to Madison follows a management overhaul in March that brought a new leadership team from Third Wave Technologies, including the new President & CEO, Kevin Conroy.

Third Wave was acquired by Hologic (NASDAQ: ) in 2008 for $582M, and the management team now at EXAS led the development through FDA approval for two human papillomavirus (HPV) molecular diagnostic tests in addition to a test for cystic fibrosis. The new executive leadership team is expected to restore investor confidence in EXAS once their strategic plan is communicated to correct the backwards development of the Company's promising sDNA technology for the average risk population in the detection of CRC.

EXAS secured inclusion for its sDNA technology in the World Gastroenterology Organization, U.S. Multi-Society Task Force, and ACS guidelines for CRC screening before successfully developing a FDA-approved, fully automated test to fully capitalize on this major commercial and preventative medicine (i.e. saving lives) opportunity. Thus, LabCorp (NYSE:LH) currently markets ColoSure on a homebrew basis with little in the way of sales or third-party reimbursement (i.e. insurance or government) - which is unlikely to change until FDA approval is secured for the Company's V3 technology.

The exclusive agreement with LabCorp runs through the end of 2010 for the use of EXACT's IP as part of a commercial testing service for CRC screening, which was launched as ColoSure last summer by LH on a homebrew, non-FDA approved basis.


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The above story is the opinion of the author only and it does not reflect iStockAnalyst opinion. Further, the author is not personally advising you regarding the suitability of the story for your investment needs. In no event iStockAnalyst will be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from or arising out of, or in connection with the use of this information. Please consult your investment advisor before making any investment decision.
  
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