Silicon Valley Biosystems (SV Bio) today announced that it has received Clinical Laboratory Improvement Amendment (CLIA) certification from the California Department of Public Health for its in silico diagnostics laboratory. Obtaining CLIA certification demonstrates that SV Bio's computational laboratory, which performs next-generation sequencing (NGS)-based diagnostics on patient samples, is consistently performing the analysis and interpretation of NGS sequencing data at an exceptionally high standard in a regulated clinical environment.
SV Bio's GermlineDx™ NGS interpretation platform, operating in its CLIA laboratory, enables customers to interpret NGS assays quickly, efficiently, and cost effectively. The GermlineDx™ platform provides a turnkey solution for clinical grade analysis and interpretation of single gene, multi-gene, whole exome, or whole genome assays for germline indications such as Mendelian disease diagnosis, carrier testing, hereditary cancer risk assessment and pharmacogenomic applications.
In combination with CLIA certification, SV Bio's GermlineDx™ platform provides a new paradigm in clinical NGS diagnostics in that the diagnostic testing is done at the software layer on a pre-generated holistic sequence from a patient. SV Bio also has a CLIA-certified ultra-high throughput NGS wet laboratory for those customers who desire a complete solution, which includes generating the genetic sequence.
"We have unlocked the value of the new sequencing technology so that it may confidently be used for human diagnostic testing and are thrilled to be first to bring to market a new type of diagnostic company and testing capability," said Dietrich Stephan, Ph.D., Founder and CEO, SV Bio. "With CLIA certification, our clients can be confident that they are receiving the highest quality diagnostic interpretation services when transitioning to NGS."
Genetic diagnostics are routinely used to guide clinical decision-making in many clinical scenarios, and the number of available genetic tests continues to increase. The dramatic rise in adoption of NGS technologies to replace "last generation" Sanger sequencing in diagnostics is being fueled by the significant cost-savings that the new technologies provide, and new health care reimbursement schemas mandate.
"In light of the importance and magnitude of decisions made downstream of DNA testing, there must be zero tolerance by the community for decreases in test performance simply to take advantage of the cost savings that these new technologies allow," said Timothy Triche, M.D., Ph.D., SV Bio Board Member and CLIA Laboratory Director.
"The latest NGS sequencers are not 'clinical grade' out of the box," said Sivan Bercovici, Ph.D., Chief Technology Officer of SV Bio. "The billions of short sequence reads that are generated by NGS machines must be rigorously analyzed with complex algorithms so that the data are of the same quality as the current gold standard. If this does not happen, NGS-based diagnostics will suffer a severe disadvantage in accuracy – meaning physicians and their patients could make critical decisions based on faulty data. SV Bio solves this problem."
The SV Bio technology platform allows clients who are transitioning to NGS to have a turnkey analysis and reporting solution, with clinical grade sensitivity and specificity, and unlocks the value of these new technologies for the entire marketplace. CLIA certification reflects and continually ensures the high quality and reproducibility of SV Bio's diagnostic test results. A somatic mutation analysis platform, SomaticDx™, is expected to be released in Q4 of 2013. This new platform allows cancer tumor mutations in patients to be identified and personalized cancer therapies to be selected in a turnkey fashion.