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Paradigm, TME Research Collaborate

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The Paradigm Neoadjuvant Breast Registry will use Paradigm’s PCDx next generation sequencing test and other advanced molecular capabilities to genomically characterize invasive breast cancer patients for targeted neoadjuvant therapies [pre-surgical treatment]. With more accurate accounts of individual gene variability driving disease, therapy selection will be refined for patient success.

The initial six-month pilot for this project will enroll 100 patients across 8 primary US centers – potentially expanding to 1000 patients across 50 US centers. Patients enrolled into the Paradigm Registry will have neoadjuvant chemotherapy or hormone therapy. The patient’s cancer will undergo tumor profiling with the Paradigm platform.

Precision oncology is an emerging approach for cancer treatment utilized mainly in the metastatic setting but with great potential to direct initial therapy. The primary goal of the Paradigm Registry is to accelerate tumor profiling based on disease biology so that relevant neoadjuvant clinical trials and/or refined treatment regimens can be identified particularly when competing options exist.

Dr. Pat Whitworth, MD, Co-Principal Investigator stated, “Conventional thinking is that neoadjuvant therapy is offered to patients with large primary breast cancer to increase the likelihood of breast conservation therapy. However, more breast oncologists are utilizing it as a way to determine if standard chemotherapy is effective. Genomic analysis of breast cancers will help refine treatment based on the patient’s individual cancer and not just population based therapies.”

Dr. Peter Beitsch MD, and Co-Principal Investigator added, ”While these new molecular tests are more commonly used to inform treatment selection when treating aggressive, rare or refractory disease, they are also becoming increasingly valuable in earlier breast cancer treatment selection and management. We look forward to working with Paradigm on this important project.”

Robert J. Penny MD, PhD, CEO of Paradigm noted, “Not only do we anticipate patients enrolled in Paradigm’s Neoadjuvant Breast Registry to benefit from tailored therapeutics, but we also aim to accelerate the pace of discovery in cancer genomics to move beyond the archaic ‘one-size-fits-all’ approach to cancer treatment. Determining if next-generation sequencing (NGS) and other technologies assist in the selection of clinical trials and targeted treatments for patients being treated in the neoadjuvant setting with improved key clinical endpoints will be a first.”

PCDx is a comprehensive clinical-grade NGS-based 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 tumors DNA, RNA & Protein. The test interrogates the most relevant genomic targets at over 5,000x average depth of coverage with 67 therapeutic associations. Results are typically delivered in 4-5 business days.