PrognosDx Health and Accium BioSciences are teaming up to co-develop and commercialize a series of predictive histone biomarker tests that combine ProgNosDx’ epigenetics technology with Accium’s accelerator mass spectrometry (AMS) platform. PrognosDx is exploiting expertise in tissue-based global cellular histone biomarkers to develop tools that provide clinicians with prognostic information on individual cancers and aid in treatment decision.
Accium’s AMS platform is an ultrasensitive detecton platform that can quantify 14C-labeled molecules at the 0.001–100 DPM/mL range. The technology, offered through Accium’s Bioanalytical and Quality service units, is used to generate clinical data on novel compounds early in Phase I trials.
“We are very much intrigued by the core intellectual property behind the platform technology, which has been exclusively licensed to PrognosDx, as well as the potential medical applications it may produce for cancer treatment,” comments Ali Arjomand, Ph.D., president at Accium. “We have identified specific studies that would help further define the developmental direction of various diagnostic tests and the potential benefits they may provide to specific patient populations.”
PrognosDx’ technology was originally developed at the University of California, Los Angeles (UCLA) and licensed to PrognosDx. The firm is developing the chromatin biomarkers into quantitative prognostic and response predictive markers for use in drug efficacy studies, for patient stratification, or for patient admission optimization into clinical trials.
Through a partnership with Flagship Biosciences, PrognosDx currently offers prostate cancer epigenetic tumor profiling services out of a CLIA-affiliated lab. The service involves testing prostate cancer biopsies or FFPE/frozen tissue samples obtained from patients who have previously undergone radical prostatectomy or other treatments to assess the level of aggressiveness of disease and chance of recurrence through analysis of global histone modifications. The tests are performed in an immunohistochemical format and the results are further analyzed using Flagship BioSciences’ advanced digital pathology algorithm to yield a quantitative laboratory test score, or “PrognoScore.”
PrognosDx says its biomarkers also represent strong predictive factors for multiple other cancers including colorectal cancer, lung cancer, ovarian cancer, breast cancer, kidney cancer, pancreatic cancer, glioma and lymphoblastic leukemia. Tests for other diseases are expected to be released into the market in 2012–14. The firm has in addition generated a confidential list of drugs that may be stratified using the tissue-based histone biomarkers.
Accium is spearheading the use of AMS in a range of diagnostic tests with potential use in personalized medicine. This approach is exemplified by an ongoing study to evaluate Merck& Co.’s Temodar® in glioblastoma multiforme patients, the firm states. Through this project Accium is providing 14C-methylation measurements of tumor DNA after 14C-labeled drug administration to identify pharmacologic or pharmacodynamic endpoints that may be predictive of response to therapy in individual patients.