bioTheranostics’ Prostate Cancer Index Predicts Risk for Prostate Cancer Recurrence

FOR IMMEDIATE RELEASE…May 2, 2013…SAN DIEGO…A new molecular test from bioTheranostics—the Prostate Cancer Index—is a strong predictor of prostate cancer recurrence and may improve upon the current standard of care for assessing risk of recurrence and metastasis in patients with prostate cancer, according to a study published online in the Proceedings of the National Academy of Sciences.

The Prostate Cancer Index (PCI), currently in development, is a 32-gene signature designed to predict prostate-specific antigen (PSA) recurrence. In the study, conducted in collaboration with Massachusetts General Hospital, the PCI was validated in an independent, blinded set of 270 radical prostatectomy tumor samples. Results showed that the PCI was prognostic for risk of PSA recurrence and had added value over standard clinical prognostic markers such as Gleason score, pathologic tumor stage, surgical margin status, and pre-surgery PSA levels (P =0.0057). Surgical margin status was the only other factor with significant prognostic value.

The study also showed that the PCI could stratify patients based on the risk of PSA recurrence and the development of metastatic disease. The categories defined by the index significantly stratified patients based on risk of metastasis: the 10-year probability of metastasis was 14 percent in the high-risk group, and 0 percent in the low-risk group
(P = 0.0006).

bioTheranostics’ CEO Richard Ding said the validation study, which strongly supports the use of PCI as a prognostic molecular marker for prostate cancer recurrence, is important because the management of prostate cancer is challenging due to the variable nature of the disease. “In the United States, more than 240,000 men are diagnosed with prostate cancer each year, and it is bioTheranostics’ Prostate Cancer Index Predicts Risk for Prostate Cancer Recurrence, Page 2 the second leading cause of cancer mortality in men,” Ding said. “Our new PCI test may help physicians make postoperative treatment selections and has the potential to impact decision making at the biopsy stage, where patients and physicians must weigh the benefits of currently available therapies against the potential morbidity of the treatments.”

Ding said the ability of the PCI to accurately determine the risk of recurrence addresses an important unmet need in the management of prostate cancer and reflects bioTheranostics’ commitment to advancing individualized cancer care with innovative molecular diagnostics. “A key clinical need is to identify patients with slow-growing or aggressive disease to aid in treatment decisions,” he said. “The PCI is the newest test in our suite of molecular diagnostic, prognostic, and predictive tests for cancer that provide valuable information for physicians and patients, helping them to select the right therapy at the right time.”

The study, “Development and Validation of a 32-gene Prognostic Index for Prostate Cancer Progression,” can be accessed here.


About bioTheranostics

bioTheranostics is the leading solution provider for metastatic cancer management, leveraging its unique expertise in expression profiling to develop a growing array of molecular diagnostic tests for cancer patients. The company operates a CLIA-certified, CAP-accredited diagnostic laboratory to perform its proprietary tests: the
CancerTYPE ID® molecular classification test; PRÉCIS® Precision Medicine, which includes biomarker profiles for non-small cell lung and colorectal cancers, and other cancers; and
Breast Cancer IndexSM, which quantifies risk of recurrence of estrogen receptor-positive, lymph node-negative breast cancer. bioTheranostics, a bioMérieux company, is based in San Diego. For more information, visit