CTC Laboratory Systems (CTCLS) negotiated distribution rights in Japan to Ariana Pharma’s KEM® (knowledge extraction and management) data mining analytics software and services. Originally developed at the Pasteur Institute, KEM is a rules-based (i.e., nonstatistical) data analysis technology for identifying patient-responder sub-populations and biomarker signatures.
The technology can be applied to guide decision making in drug discovery, characterize responder and nonresponder populations in clinical trials, and detect/evaluate drug-related adverse events, risk factors, and at-risk populations. KEM can also be applied to identify predictive biomarkers of clinical adverse events, safety and efficacy, and biomarkers for potential applications in prognostic and companion diagnostic assays.
Ariana has provided its KEM Biomarker technology to FDA since 2010 to help agency reviewers analyze pharmacogenomic data in combination with patient characteristics for biomarker signatures submitted through the FDA’s Voluntary Exploratory Data Submission (VXDS) program. The firm also has a collaboration with Bio-Rad France and AP-HP (Beaujon Hospital) and INSERM’s joint center of excellence for viral hepatitis focused on applying the KEM technology to the discovery of biomarkers for the early diagnosis of fibrosis and prediction of treatment resistance.
Headquartered in Paris, France, Ariana established a permanent base in Cambridge, MA earlier this year to support its client base in the U.S.