AMA Issues PLA Codes for Variantyx’s Genomic Unity® Test Series

Medicare/Medicaid Insurance Reimbursement for Variantyx’s Genetic Tests Will Accelerate the End of a Long, Cumbersome, and Costly Process for Genetic Disease Diagnosis

BOSTON--(BUSINESS WIRE)--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

About Variantyx:

Variantyx is a clinically accredited genetic testing lab with the industry’s first comprehensive, all-in-one methodology for diagnosis of inherited disorders. Variantyx’s Genomic Unity® eliminates the need to order multiple independent tests, resulting in more diagnoses in a shorter period of time, and with lower overall costs. The company’s testing methodology is based on whole genome sequencing (WGS) and is performed using an in-house developed analytical platform built and optimized for WGS data. The company’s proprietary algorithms identify a wide range of difficult-to-detect sequence variants. Through its ability to accurately and economically make sense of the vast amounts of data generated by WGS, Variantyx is effectively leading the way to routine, comprehensive genetic testing one patient at a time. Headquartered in Boston, MA the company was founded in 2014, and has raised $18 million in capital from investors including Pitango Venture Capital and New Era Capital Partners. For more information, visit https://www.variantyx.com/.