CAMBRIDGE, Mass.--(BUSINESS WIRE)--KEW, Inc., a privately-held comprehensive genomic profiling company with headquarters in Cambridge, MA, USA, today announced the publication of analytical validation of its flagship NGS-based CANCERPLEX® platform for guiding clinical decisions in cancer care.
The article describes the results from 1,000 tumor samples profiled in KEW’s CLIA-certified, CAP-accredited clinical laboratory in Cambridge, MA, with CANCERPLEX®. The tumor samples were diverse including FFPE, core-biopsies, fine-needle aspirates and effusions and were representative across many different solid tumor types including lung (31%) colorectal (35%), gastric and esophageal (15%) and breast (9%).
The study demonstrates KEW’s orthogonal validation of somatic genomic variants in solid tumors characterized by CANCERPLEX® with specificity and sensitivity >99.5% and limit of detection for allele fraction as low as 10% for Single Nucleotide Variants (SNVs), base insertions and deletions (InDels) and Copy Number Variations (CNVs). For structural variants, genomic aberrations were detected in ALK, RET and ROS1 in 5% of NSCLC cases profiled, as expected, and was ≥99.9% accurate when tumor nuclei ≥20%. The article also details the capacity of CANCERPLEX® to determine microsatellite instability (MSI) status, tumor mutation burden and viral association, additional critical factors in determining optimal patient care, particularly for patients who may gain therapeutic benefit from immune checkpoint inhibitors.
Overall clinical actionability was 93% in which patients were matched with therapeutic options based on their individual tumor molecular profile, emphasizing the robust utility of CANCERPLEX® in guiding therapeutic decisions in cancer care.
“Rapid advances in genomic sequencing technology and growing insights into the underlying molecular etiologies of cancer over the last decade have ushered in the era of Precision Medicine,” said Raju Kucherlapati, Ph.D., Paul C. Cabot Professor of Genetics and Professor of Medicine, Harvard Medical School and Founder of KEW, Inc. “KEW was originally founded to make Precision Medicine a reality for all patients, particularly in the community setting. The publication of our current analytical validation study in concert with the publication of previous studies using CANCERPLEX® underscores the utility of CANCERPLEX® for providing high-quality comprehensive genomic profiling analysis across all solid tumor types in broad patient populations for both guiding optimal cancer care and in furthering our knowledge about the molecular heterogeneity of cancer.”
“This study not only demonstrates the ability of CANCERPLEX® to identify individual tumor-specific genomic variants for matching patients with therapeutic options, but further stresses the critical need for comprehensive genomic profiling on limited tumor specimen in guiding quality cancer care,” said Jerry Williamson, President and Chief Executive Officer of KEW, Inc. “CANCERPLEX® provides robust, clinically-actionable results across all solid tumors for improving the quality of life for patients everywhere.”
The article, “Clinical Application of a Cancer Genomic Profiling Assay to Guide Precision Medicine Decisions,” published in the journal Personalized Medicine is available for PubMed online access on June 2, 2017.
CANCERPLEX® is a comprehensive genomic profiling platform for sequencing over 400 cancer-related genes, providing treatment decision support for cancer patients based on a patient’s tumor genomic profile. Using industry-leading sequencing approaches and robust data analytics, a sample acceptance rate of >95% and a rapid turn-around time of 7-10 business days, CANCERPLEX® provides therapeutic options to 93% cancer patients profiled.
About KEW, Inc.
KEW, Inc. is a privately-held comprehensive genomic profiling company with headquarters in Cambridge, MA, USA., dedicated to revolutionizing cancer care by providing therapeutic options based on an individual patient’s tumor genomic profile. CANCERPLEX® is KEW’s flagship clinical product family for sequencing and identifying applicable targeted therapies and clinical trials. KEW has been working with molecular labs to enable their local delivery of comprehensive genomic profiling in the community setting.