New Studies Demonstrate the Clinical Application of Predicine’s Liquid Biopsy Assay to Detect Gene Copy Number Loss in Patients with Metastatic Prostate Cancer

Results from the studies utilizing Predicine’s blood-based liquid biopsy assay to detect copy number loss in PTEN, RB1, TP53, etc. are now published in Frontiers in Oncology and JCO Precision Oncology, respectively.

Predicine, Inc. announced today results from two liquid biopsy studies demonstrating the technical capability and clinical application of the PredicineCARE™ liquid biopsy NGS assay to detect copy number variation (CNV), especially copy number loss, in patients with metastatic prostate cancer.

The Frontiers in Oncology study demonstrated a high degree of concordance of CNV detection on a paired sample set of matched blood and tissue biopsy from patients with metastatic castration-resistant prostate cancer (mCRPC), which were tested by IHC, PredicineCARE and low pass whole genome sequencing (LP-WGS). The study is entitled “Circulating Cell-Free DNA-Based Detection of Tumor Suppressor Gene Copy Number Loss and Its Clinical Implication in Metastatic Prostate Cancer”. The JCO Precision Oncology study reported that blood-based PTEN loss and PIK3CA gain has been found in 37% (85 of 231) and 17% (39 of 231) of mCRPC patients, respectively. The study is entitled “Plasma Cell–Free DNA Profiling of PTEN-PI3K-AKT Pathway Aberrations in Metastatic Castration-Resistant Prostate Cancer”. Both studies demonstrated the prognostic value of loss of PTEN and gain of PIK3CA and AR in patients with mCRPC.

Detection of PTEN copy number loss represents a life-saving opportunity to several millions of patients with metastatic prostate cancer, who may benefit from targeted therapies such as AKT inhibitors (Ipatasertib, Capivasertib) where PTEN loss is a predictive biomarker. However, the difficulties of obtaining bone tumor tissue from metastatic sites and the technical challenges in liquid biopsy to detect gene deletions make it an unmet diagnostic need for precision medicine. The capability of the PredicineCARE liquid biopsy assay to identify copy number loss constitutes an important step towards the practice of precision medicine for patients with prostate cancer.

“Blood-based detection of copy number loss has been an unmet clinical need for many years” said Dr. Shidong Jia, Founder and CEO at Predicine. “We are pleased to provide a next-gen liquid biopsy solution that may have profound clinical implications including predicting patient survival, selecting therapies for treatment, and understanding subsequent resistance. Predicine was founded to address these types of unmet clinical needs, such as PTEN loss in cancers. No patients should be left behind.”

The publications can be found online at:

Official press release can be found: (HERE)

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