A Medical Device Daily
Exact Sciences (Marlborough, Massachusetts) reported that it has signed a letter of intent with Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) to further strengthen and expand their relationship related to Exact’s stool-based DNA technologies for colorectal cancer (CRC) screening.
Specific provisions of the letter of intent preserve the economic value of the prior relationship, including all royalties on PreGen-Plus sales as well as $40 million of existing milestone payments that Exact may receive from LabCorp. The letter of intent also provides for an additional $2.5 million milestone payment related to the inclusion of sDNA testing in the updated CRC screening guidelines, Medicare reimbursement and specified increases in sales of PreGen-Plus. Exact and LabCorp remain committed to the launch of Version 2 of Exact’s stool-based DNA technology in the first half of 2008. This improved version demonstrated 88% sensitivity for detecting colorectal cancer in a recent multi-center study.
Current operating plans, which assume Exact’s timely optimization and validation of its Version 2 technology as well as the intended relocation to a smaller facility, should allow further decreases in expenses beyond the anticipated marketing and sales reductions. Going forward, Exact said it intends to direct its resources and energies on the following: Pursuing inclusion of sDNA in the updated CRC screening guidelines; obtaining Medicare coverage for sDNA technology; obtaining and broadly exploiting the value of Exact’s CRC technology and intellectual property
Exact Sciences uses applied genomics to develop screening technologies for use in the detection of cancer.
LabCorp takes part in genomic testing.
In other agreements, Cardinal Health , (Dublin Ohio), reported an exclusive, four-year distribution agreement with HemCon Medical Technologies (Portland, Oregon) to provide its new line of hemorrhage control bandages to hospitals, surgery centers and physician offices in the U.S.
HemCon Bandages, used by the U.S. military since 2003, have demonstrated a 97% effective rate in controlling bleeding on the battlefield. HemCon said it recently reengineered its bandages to meet the specific needs of civilian trauma and emergency medicine. The new bandages, which control severe arterial bleeding, are thinner, more flexible and sized differently than the original HemCon military bandage. The technology used in the bandages is particularly useful in hospital settings, because it allows providers to standardize one hemorrhage control solution across multiple disciplines, according to the company.
Using Chitosan, an extract from shrimp shells, the HemCon Bandage controls moderate to severe external bleeding within minutes of being applied directly to moderate- or high-pressure, high-flow external bleeds. It aggressively adheres to the site when it contacts blood or moisture. This adhesive-like action forms a strong, flexible barrier that seals and stabilizes the wound. The companies said that by directly controlling blood loss, even in the case of severed arterial bleeds, HemCon Bandages reduce the need for transfusions and provide critical time to administer care (up to 48 hours from the point of placement).
HemCon’s new bandages will be available in a variety of sizes, have a three-year shelf life and are latex-free. These sizes were chosen to specifically address the wounds seen in civilian emergency and trauma cases such as lacerations, knife injuries, motor vehicle accidents and gunshot wounds. In addition to being useful in the emergency room, HemCon Bandages are also useful in cardiac catheterization and interventional radiology settings.
Cardinal Health is a global provider of healthcare products and services.
HemCon develops technologies to control bleeding and infection resulting from trauma or surgery.