InGen BioSciences has secured exclusive French rights to distribute the FDA-approved ImmuKnow assay made by U.S.-based Cylex Inc., the companies announced. The Cylex assay, which complies with the IVDD and has the CE mark, detects changes in global immune function over time in patients receiving immunosuppressive therapy for organ transplants. InGen BioSciences specializes in mono- and multiparametric IVD tests for detecting immunity.

ImmuKnow uses a 1-ml blood sample to assess immune cell function and aid doctors in managing treatment of allograft transplant patients. The assay enables doctors to tailor immunosuppressant drug regimens in order to prevent organ rejection while avoiding infection, according to Cylex. The assay’s three immunological response zones of strong, moderate, and weak can guide physicians in patient management, the company says. ImmuKnow is sold in 18 countries.

InGen BioSciences cites studies showing that long-term use of immunosuppressants is associated with significant morbidity and mortality in transplant recipients. The studies also show that current monitoring of immunosuppression in those patients typically focuses on prevention of clinical toxicities of immunosuppressive drugs. Minimizing the risk of infection and rejection in post-transplant patients is therefore crucial and challenging for clinicians, according to the company. Unfortunately, these strategies are often not tailored to the individual and do not determine the optimal level of immunosuppression for these patients.

"This distribution partnership with InGen BioSciences represents an exciting opportunity for offering the best possible services to French transplant professionals seeking to provide individualized management for their patients,” says Brad L. Stewart, president and CEO of Cylex.

The exclusive partnership with Cylex “reinforces our innovative offerings in immunology, complements our HLA IVD portfolio, and strengthens our positioning in integrated, concrete best-in-class solutions for present and future needs of healthcare professionals in the rapidly evolving field of diagnostics," says Isabelle Buckle, CEO of InGen BioSciences.

 Founded in 2001, InGen BioSciences launched its first proprietary product in 2011. Called the BJI InoPlex, the device is a noninvasive system for detecting infections in pre-and post-operative implants for orthopedic surgeons, infectious diseases specialists, and other healthcare professionals.