Abbott said today that has signed an agreement to collaborate with Astellas Pharma Global Development in a phase III clinical trial for Astellas' investigational vaccine to prevent cytomegalovirus reactivation in transplant patients.
Under the agreement, researchers from the companies will use Abbott's RealTime CMV assay on the m2000 System to monitor patients for CMV viral load in order to assess the efficacy of the vaccine, called ASP0113, or TransVax.
The companies noted that CMV, a herpes virus, infects half of all adults by age 40 and is the most common infection in transplant recipients. Hematopoietic cell transplant patients and other individuals with depressed immune systems are vulnerable to severe complications from CMV infection, including CMV disease and death.
The Abbott m2000 is an automated system for DNA and RNA testing that comprises the m2000sp module for automated sample extraction preparation and the m2000rt instrument for real-time PCR detection and analysis. The platform received 510(k) approval from the FDA in June 2010 along with a combined molecular diagnostic test for chlamydia and gonorrhea.
Abbott's RealTime CMV assay is currently for research use only.
This is the fourth partnership that Abbott has announced in the last year with a pharmaceutical company involving molecular testing on the m2000. The company's other collaborations — with Pfizer, GlaxoSmithKline, and Merck — focus on the development of companion diagnostic tests for use in selecting patients for novel oncology therapeutics.