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Exact Sciences - Validation Data Expected in the Coming Months

|Includes: EXACT Sciences Corporation (EXAS)

Investors can expect significant news in the coming months/weeks from Exact Sciences (NASDAQ:EXAS). The company has disclosed that results from its preclinical validation study, along with full biomarker panel data, will be released in 2H10.  We're expecting greater clarity from management in the coming days/weeks.

Below is an excerpt from our latest report on EXAS to research clients:

EXAS is developing a next generation, non-invasive colon cancer screening assay as an alternative to colonoscopy, FOBT (fecal occult blood test) and FIT tests (fecal immunochemical test).  EXAS’s stool-based sDNA test is targeting a cancer sensitivity of 85% and a pre-cancer sensitivity of 50%.  EXAS’s previous assay, PreGen-Plus, had sensitivities of 52% and 18% and suffered from limited clinician uptake. In 2007, EXAS received an FDA warning letter that stated a PMA would be required to continue commercialization. 
In April 2009, EXAS brought in new management (Kevin Conroy as CEO and Maneesh Arora as CFO) from Third Wave Technologies after its $580M acquisition by Hologic.  While at Third Wave, Conroy and Arora developed and received approval for Cervista, an HPV assay utilizing the Invader chemistry detection process, a highly specific chemiluminescent amplification technology. 
In June 2009, EXAS licensed exclusive rights to intellectual property developed by David Ahlquist at Mayo Clinic. The licensed patents cover sample processing, analytical testing and data analysis specifically for non-invasive, stool-based DNA screening for colorectal cancer.
In October 2009, EXAS licensed worldwide rights to Hologic's Invader plus and real-time Invader detection chemistries for colorectal screening applications.
EXAS now plans to use the Invader technology along with a better DNA extraction process (magnetic bead capture vs. DNA precipitation) which yields ~10X more DNA than the legacy method.  The new method will also offer a shorter sensitivity time of 3 hours vs. 48 hours.

To read the full report and learn more about EXAS's validation study, please visit or email us at

Andrew Nava LLC provides institutional and retail healthcare investors with buy-side equity research tools that focus on value-driven investing, profitable trading ideas and clinical, commercial, and regulatory catalysts. Our research is supported by our database of clinical trial data and upcoming company milestones and by consulting with KOL's, industry professionals, analysts, and company management.

Disclosure: No positions