Once these favorable trends become apparent in the quarterly results, HDIX should find its way back to double digits around consensus analyst price targets of 10 bucks per share.
Earlier this month, AspenBio Pharma (APPY) completed enrollment in its pivotal Phase 3 clinical trial for AppyScore, which represents the first blood-based diagnostic screening test for appendicitis. On December 10, APPY guided for a time frame of 4-6 weeks for announcing the trial results with plans for an early 2009 submission for FDA approval in the form of a 510(k), which means results could be released within the next 2-4 weeks and provide an upside catalyst if the results support approval by the agency – with the added bonus of no safety concerns since the test is non-invasive.
EXACT Sciences (EXAS) has experienced a string of good news in the past 10 days, indicating wider acceptance of its non-invasive stool-based DNA (sDNA) colorectal cancer screening test by a trio of states and a major insurance company. While EXAS is up nearly 50% in the past month, the Company has lost over three-quarters of its market value in the past year.
New Jersey and
Maryland added sDNA testing to their colorectal cancer screening mandates while Cigna (CI)
included the sDNA test as a covered benefit on a national basis.
Also, Massachusetts added the screening test to its Care Coordination Program for low-income individuals over age 40. Finally, University Hospitals Case Medical Center of Cleveland recently announced a pilot program for sDNA screening at two sites which will feature the test as the preferred option for those who are unwilling or unable to obtain a colonoscopy.
While EXAS represents my biggest loss for the year and has been a train wreck since I first wrote about the Company in October 2007; recently appointed Board member and healthcare dealmaker, Michael Singer, summarizes the remaining value drivers as follows:
1.) a portfolio of intellectual property in non-invasive prenatal diagnostics, non-invasive colorectal, and aero-digestive cancer screening
2.) the recent American Cancer Society endorsement of sDNA testing
3.) the commercial launch of ColoSure by LabCorp (LH)
4.) EXACT's long-standing relationships with scientific pioneers at Johns Hopkins University, Case Western Reserve University, and other leading medical institutions.