A Medical Device Daily
Fujirebio Diagnostics (Malvern, Pennsylvania) and Roche Diagnostics (Basel, Switzerland) have signed a worldwide license and supply agreement for the HE4 ovarian cancer test.
Roche will develop an assay kit using Fujirebio Diagnostics' HE4 test on its automated immunoassay analyzers.
The HE4 test was developed by Fujirebio to be used in conjunction with the company's existing CA125 biomarker, the gold standard for monitoring ovarian cancer. This combination of biomarkers, as published clinical data shows, provides clinicians with a diagnostic tool that can provide higher sensitivity and specificity than CA125 alone. Improved sensitivity and specificity should allow clinicians to distinguish between benign and malignant pelvic masses more accurately, helping to ensure that patients receive appropriate therapy earlier.
"This novel biomarker HE4 will allow our longstanding partner Roche Diagnostics to provide clinicians worldwide with a much needed tool to better define a pelvic mass, enabling women at higher risk for cancer to see the right physician earlier," said Paul Touhey, president/CEO, Fujirebio Diagnostics.
HE4 in a manual format is currently FDA-cleared for monitoring recurrent or progressive disease in patients with epithelial ovarian cancer (EOC), and CE-marked in Europe as an aid in estimating the risk of EOC in premenopausal or postmenopausal women presenting with pelvic mass. The HE4 manual test and corresponding Risk of Ovarian Malignancy Algorithm (ROMA) are pending clearance by the FDA for use in women who present with a pelvic mass.
In other agreements/contracts news:
• OmegaGenesis (Gilroy, California) reported a collaboration with Mayo Clinic (Rochester, Minnesota) for the discovery and validation of nanomaterials used for angiogenesis applications.
Angiogenesis plays an important role in a wide variety of medical applications ranging from tissue reactivation and healing of common wounds to controlling the growth and spread of cancer and malignancies. In cancer and malignancies, new blood vessels feed the cancer cells with oxygen and nutrients, allowing these cells to grow, invade nearby tissue, spread to other parts of the body, and form new colonies of cancer cells.
At Mayo Clinic, researchers have produced one of the rare earth materials in nano size and established non-toxicity of the material for human applications. Additionally they have shown the material induces endothelial cell growth and produces new blood vessels. OmegaGenesis is developing applications based on these unique characteristics of nano materials for proactive maintenance of the human body.
• Centinel Spine (Minneapolis) said that further to its strategic integration plan with Surgicraft Group Holdings (Worcestershire, UK), Centinel Spine has retained exclusive U.S. distribution rights to the STALIF TT Stand Alone Lumbar Interbody Fusion Device Technology with immediate effect.
Centinel now has exclusive distribution rights to market STALIF TT products in all markets and countries globally. Centinel Spine expects to see increased revenue from this technology as early as 1Q09.
• Premier Purchasing Partners (San Diego) said that new agreements for surgical endoscopy and video equipment have been awarded to ConMed (Utica, New York) and Olympus America (Center Valley, Pennsylvania). The category has been expanded to encompass the range of products currently found under the GI Products and Equipment category.
Effective Jan. 1, 2009, agreements are available to acute care and continuum of care members of the Premier healthcare alliance.
Also, Riverside Medical Center (Kankakee, Illinois) reported that it expects supply savings of more than $500,000 by joining the Illinois Purchasing Collaborative, an Illinois Hospital Association (Naperville, Illinois) program that partners with the Premier healthcare alliance to reduce members' supply chain costs.
The cost analysis process identified a 92% exact and equivalent product match rate to Riverside's former group purchasing organization product portfolio in the medical-surgical and pharmaceutical product areas.