Diagnomics CLIA Validation
Proprietary algorithms use NGS to detect multiple fetal genetic abnormalities from non-invasive samples
Dec 08, 2015, 08:00 ET from Maverix Biomics, Inc.
SAN MATEO, Calif., Dec. 8, 2015 /PRNewswire/ — Maverix Biomics, Inc., a leading genomic analysis software company, and Diagnomics, a developer of innovative products and services for personalized medicine based on Next Generation Sequencing (NGS) technology, today announced their achievement of Clinical Laboratory Improvement Amendments (CLIA) validation for NGS based Pre-natal Testing using the Maverix Dx Platform. The platform is a cloud-based Next Generation sequencing data analysis system for reference laboratories and diagnostic testing sites.
Research demonstrates that the risk of aneuploidy, which is the absence of either a chromosome from a pair (monosomy), or the presence of more than two chromosomes of a pair (trisomy), statistically increases after 35 years of maternal age. Diagnomics and the Eone-Diagnomics Genome Center (EDGC), a joint venture between Diagnomics and Eone Life Science Institute in Korea, developed the NICE® (Non-Invasive Chromosome Examination) proprietary algorithms using NGS technology to detect multiple fetal chromosomal aneuploidies from cell free DNA. “NICE®Bioinformatics” delivers the NICE® algorithms on a clinically approved cloud-computing platform, Maverix Dx, provided by Maverix Biomics. Joint efforts by Diagnomics, EDGC, and Maverix resulted in the delivery of a valuable diagnostic test that is clinically and scientifically validated on the Maverix Dx platform.
The Maverix Dx platform is designed to be part of a regulatory compliant workflow for genetic/genomic data analysis and provides quality management features that comply with CLIA and CAP regulatory needs. The Maverix Dx platform offers simple and easy NGS data analysis to produce reliable, consistent, and reproducible results. The platform is integrated with a Laboratory Information system (LIMS) for clinical and diagnostic testing.
“By achieving CLIA validation for NICE®, we are further delivering on our promise to provide genomic sequencing and bioinformatics solutions that assist healthcare professionals worldwide in better understanding the genetic influence of personal health and disease,” said President of Diagnomics and CEO of EDGC Min Seob Lee. “Our partnership with Maverix has enabled us to demonstrate the positive influence next generation sequencing has on complicated clinical diagnostics testing.”
CLIA director, Philip Cotter, Principal, ResearchDx, Inc., administered the CLIA validation process of NICE® on the Maverix Dx platform. “The design of the Maverix Dx platform enabled the execution of complex clinical molecular diagnostic testing in an efficient and simple manner. I was pleased to see that the data review, sample management and approval process easily complied with CLIA regulatory expectations.”
“The CLIA validation is an important benchmark in our ability to deliver a clinical diagnostic platform,” said Tom Kent, President of Maverix Biomics. “We are pleased to have worked with Diagnomics on enabling the NIPT test and we look forward to establishing additional partnerships that will facilitate more clinical diagnostics tests in the future.”
“The use of the Maverix Dx platform for prenatal diagnostic testing demonstrates that our technology meets the standards of the CLIA validation process and is specifically designed to be part of the genetic compliance for regulatory needs,” said Byung-in Lee, VP, Product Operations and Quality at Maverix Biomics. “We are confident in the platform’s ability to further help researchers and clinicians enhance the health of individuals and advance the state of health care.”
About the Maverix Dx Platform
The Maverix Dx Platform is a cloud-based solution designed for use by reference laboratories and diagnostic test developers. It leverages technologies developed and proven as part of the Maverix Analytic Platform, including open-source algorithms as well as supporting proprietary algorithms developed to implement specific genomic-based tests and diagnostics. After loading sequence data from instruments located at one or more geographic locations, the diagnostic analysis is performed, and merged with additional information provided from external Laboratory Information Management Systems. PDF summary reports, including clinical reports, are generated and delivered through a web-based Provider Portal for viewing and downloading. The Maverix Dx Platform is designed to be part of a regulatory compliant workflow from sample to results.
About Maverix Biomics
Based in San Mateo, CA and backed by leading venture capital firms and Silicon Valley investors, Maverix Biomics, Inc. provides researchers with a cloud-based platform to manage, analyze, and visualize genomic data, build Communities of Discovery, and place their data in context with the latest public data from the full spectrum of life, including human, plant, animal, or microbial organisms.
SOURCE Maverix Biomics, Inc.