BioNano Genomics, Inc. (BNGO) Customer Praxis Genomics Receives DEX Z-Codes from Palmetto for their Whole Genome Analysis LDT on Saphyr

Bionano Genomics, Inc. (Nasdaq: BNGO) announced today that Praxis Genomics, LLC received DEX Z-codes from Palmetto MolDX for its entire testing menu of laboratory developed tests (LDTs) based on Saphyr. The DEX Z-Code modifier is a unique 5-character alpha-numeric code associated with certain molecular diagnostics tests and is typically used by certain payers as an adjunct to non-specific CPT codes when no specific CPT code applies. The code, submitted on a claim along with a particular CPT code provides greater clarity to help payers and physicians understand which test is being ordered, performed and billed. The process removes the need for the provider to submit large amounts of additional information with every claim and can expedite claim payment. The assignment of DEX Z-codes to Praxis’s menu of Saphyr-based LDTs is potentially a major step forward in the coding and eventual coverage of Saphyr-based tests.

Praxis is the first CAP-accredited, CLIA-certified diagnostic lab in the United States to develop and offer commercially an LDT based on whole genome analysis with Saphyr. Praxis uses optical genome mapping (OGM) as an alternative to traditional methods of chromosomal microarray (CMA) and karyotyping (KT), as they seek to improve the rate of clinical diagnosis for patients with genetic disease. The Z-codes allow for a path for Medicare coverage and private insurance reimbursement for OGM with Saphyr of patients with suspected genetic disease.

The Saphyr system is capable of handling Praxis’ sample workload after the latest updates to the system enabled it to map 96 human samples per week, or about 5,000 per year. Bionano continues to focus on improving the throughput of OGM for even higher volume laboratories and aims to increase the throughput of a single system to as much as 17,000 samples per year by the first half of 2023, while reducing the consumables cost to a target price of $100 per sample.

“We are impressed with the progress of Praxis Genomics and its founder Dr. Peter L. Nagy towards making OGM a first line test for genetic disease genome analysis,” commented Erik Holmlin, PhD, CEO of Bionano Genomics. “Following Praxis’ CAP accreditation, we believe that the assignment of MolDX Z-codes for Saphyr testing is an important next step to enable more widespread reimbursement of OGM by private and public payers. Praxis once again is the first U.S. laboratory to pass this milestone, and we believe other U.S. labs will follow in Praxis’ footsteps over time and build the path towards reimbursement. Bionano continues to invest in making OGM faster and even more cost effective to make it the cytogenomics solution suiting the full range of testing volumes, from small, local cytogenetics labs to high-volume commercial or academic testing sites.”

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