Paradigm Cancer Diagnostic Test (PCDx) Performed Better Than FoundationOne In Side by Side Clinical Study

PHOENIX, and ANN ARBOR, Mich., April 28, 2015 /PRNewswire-USNewswire/ -- Data from a small cohort published OncoTargets and Therapy today shows that the Paradigm Cancer Diagnostic Test (PCDx) performed better than Foundation Medicine's FoundationOne test across a number of key clinical variables, including turnaround time (TAT) and clinically actionable biomarker targets.

The purpose of the analysis was to interrogate and assess how two commercially available NGS platforms for profiling cancer patients compared with each other. 

In this study, paired tumor blocks from 21 patients, 10 male: 11 female; median age 56 (35-65) with advanced solid tumors was submitted to both vendors for NGS analysis between 3/2014 and 9/2014, the first six months PCDx was commercially launched.  Patients had either a cancer type with no standard of care or had demonstrated progression on >1 line of systemic therapy.  Turnaround time (TAT) was calculated from date of received at the vendor to time of first NGS report. A biomarker was considered actionable if the has a published association with a treatment response in humans.  The assay report was assigned the highest of the following categories based on the list of actionable biomarker(s); commercially available drug (CA) highest, clinical trial drug (CT), or neither option (NO) lowest.

In the analysis, PCDx reported results faster than FoundationOne in 20 cases.  When received at both vendors on the same day, PCDx reported results first for 14 of 15 cases, with a mean TAT 9 days earlier than FoundationOne (range -7 to 14 days not excluding weekends and holidays). PCDx and FoundationOne reported a CA 14 and 5 times, CT 0 and 5 times, and None 7 and 11 times; respectively. Categorization of CA compared to CT and None significantly favored PCDx. PCDx provided higher ranking actionable targets for nine cases vs. one case for F1, while the remainder had equivalent ranking for actionable targets.

PCDx is a NGS based diagnostic test that is designed to provide physicians and patients with a more targeted, personalized approach to cancer treatment by identifying the underlying genomic and proteomic alterations of a patients tumor's DNA, RNA & Protein.

"There has been a recent surge in the number of NGS-based platforms available to clinicians over the past year," noted Jay Andersen, MD, medical oncologist at Compass Oncology in Portland, Oregon and US Oncology Breast Cancer Research Associate Chair. "These types of analyses are important as we make decisions about which platform to utilize for our cancer patients moving forward."

Paradigm provided the researchers at Western Regional Medical Center, Inc. with PCDx assay testing, and had no role in the control of the data and information submitted for publication.

About PARADIGM

Paradigm is a molecular information corporation established to bring cutting-edge diagnostics to cancer patients and clinical trials by providing information about the genomic makeup of the patient's cancer and potential therapies based on the specific characterization of the patient's tumor that can impact the patient's course of treatment. Paradigm's Next-Generation Sequencing based diagnostic test PCDx provides oncologists and patients with more precise information about the specific cancer pathways in the patient and associations between the pathways and the specific drugs available that can affect the cancer to allow for more effective decision-making. The test is driven by supporting data and literature and provides more choices for patient care than currently available on the market. For more information visit http://www.paradigmdx.org.

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SOURCE Paradigm