Abbott has signed an agreement to collaborate with Astellas Pharma Global Development in a phase 3 clinical trial for ASP0113 (TransVax), an investigational vaccine licensed from Vical Incorporated for preventing cytomegalovirus (CMV) reactivation in transplant patients.
Under the agreement, Abbott’s RealTime CMV assay, which is performed on the Abbott m2000 System and intended for investigational use only, will be used to monitor patients for CMV viral load in order to assess the vaccine’s efficacy. Viral load is a measure of the severity of a viral infection or the amount of active virus in the blood.
A herpes virus, CMV infects half of all adults by age 40 and is the most common viral infection in transplant recipients. After primary infection, CMV establishes lifelong latency without causing symptoms. The virus is often dormant in those who are healthy but can cause illness in immunocompromised people, such as those undergoing stem cell or organ transplants. Haematopoietic cell transplant patients and other individuals with depressed immune systems are vulnerable to severe complications from CMV infection, including CMV disease and death.
"Our agreement with Astellas gives us an opportunity to collaborate with another leader in the health care industry to better monitor patients to ensure proper treatment," said John Coulter, head of Abbott’s molecular diagnostics business. "Abbott’s investigational CMV test will be used as an important aid in assessing the efficacy of this promising vaccine which could significantly improve the overall outcome of transplant procedures."
This agreement represents the fourth partnership that Abbott has announced in the last 12 months with a leading pharmaceutical company. Recent collaborations with Pfizer, GlaxoSmithKline and Merck focus on the development of companion diagnostic tests for use in selecting patients for novel oncology therapeutics.
With more than 1,200 global placements, Abbott’s automated molecular diagnostics system, the m2000 System, utilizes real-time polymerase chain reaction (PCR) technology for detecting and monitoring infectious diseases and is designed to provide clinical laboratories a unique system that fully automates all of the complex and heavily manual steps often associated with molecular diagnostics. Abbott currently markets the m2000 System and a broad menu of assays globally, and is the only molecular diagnostics supplier to offer viral load assays for HIV, HBV, HCV, and a combination test for chlamydia and gonorrhoea on a single molecular platform. Abbott’s RealTime CMV assay is currently available in countries that recognize the CE Mark.
Abbott Molecular is a leader in molecular diagnostics — the analysis of DNA and RNA at the molecular level. Abbott Molecular's tests can also detect subtle but key changes in patients' genes and chromosomes and have the potential for earlier detection or diagnosis, can influence the selection of appropriate therapies, and may improve monitoring of disease progression.