June 29, 2020
Variantyx has announced that the company’s Proprietary Laboratory Analyses (PLA) codes for its genetic tests using whole genome sequencing (WGS) methodology have been officially issued by the American Medical Association (AMA).
The codes, which are used for insurance reimbursement purposes, will be reviewed by the Centers for Medicare and Medicaid Services (CMS) in their standard process for pricing for publication in the finalized Medicare Clinical Lab Fee Schedule (CLFS), which will be issued in October of 2020. At the end of the year, the AMA will release its updated coding manual and Variantyx’s name will appear in connection with its PLA codes as the manufacturer/service provider.
Variantyx has developed a clinical platform built and optimized for WGS data analysis, interpretation and reporting. The platform uniquely identifies a wide range of difficult-to-detect sequence variants which are then ranked by looking at genes that most closely match the patient’s clinical symptoms. This provides the most comprehensive diagnostic data, all with a single patient sample that is less expensive and less emotionally taxing on patients and families. Genetic testing offered by Variantyx provides the shortest time to a diagnosis and the best chance at implementing timely treatments.
“Our approach is a much faster and cost-effective route to the proper diagnosis and treatment for both early and late onset diseases and can be used to diagnose almost any genetic disorder,” said Daryl Spinner, Vice President for Market Access and Reimbursement for Variantyx. “It will soon become a first line of defense, rather than a last resort for families or individuals and their doctors seeking clarity on genetic diseases because of its ability to extract comprehensive and robust variant information from whole genome data – information that is missed by other testing approaches.”
The following PLA codes were issued by AMA and are under consideration for pricing by CMS:
Genomic Unity Whole Genome Proband – 0212U
Genomic Unity Whole Genome Comparator – 0213U
Genomic Unity Exome Plus Proband – 0214U
Genomic Unity Exome Plus Comparator – 0215U
Genomic Unity Ataxia Repeat Expansion Analysis (12 genes) – 0216U
Genomic Unity Comprehensive Ataxia Sequence and Repeat Expansion Analysis (51 genes) – 0217U
Genomic Unity DMD Analysis – 0218U
Variantyx is a CLIA/CAP laboratory providing Genomic Unity®, a whole genome sequencing (WGS)-based testing program for diagnosis of rare inherited disorders. Its single method approach to comprehensive genetic testing identifies multiple variant types within a single patient sample to provide a unified clinical report. For more information, please visit www.variantyx.com.