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SAN DIEGO - Centers for Medicare & Medicaid Services (CMS) has posted a preliminary payment determination of $1,263.53 for a new genetic testing procedure code, according to a statement from Bionano Laboratories, a subsidiary of Bionano Genomics, Inc. (NASDAQ:BNGO).
The Category I Current Procedural Terminology (CPT) code 81354 covers optical genome mapping (OGM) used to detect structural and copy number variations related to constitutional genetic disorders. This rate is $363.53 higher than the comparative microarray code 81228 and $103.53 higher than code 81229.
This is the second CPT code established for optical genome mapping, following a previous code for hematologic malignancy analysis. Both codes are expected to be officially priced in the next CPT codebook effective January 1, 2026.
Bionano Laboratories offers two tests expected to be covered by this new code: OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV. These tests are indicated for clinical presentations including developmental delay, intellectual disabilities, and autism spectrum disorder.
"Pricing at this level, which is higher than the microarray codes, is consistent with the needs of laboratories today seeking to move forward from legacy methods," said Alka Chaubey, chief medical officer of Bionano, in the press release.
CPT codes are key components for obtaining reimbursement from third-party payers when laboratories use tests based on optical genome mapping as alternatives to traditional cytogenetics methods such as karyotyping, fluorescence in-situ hybridization, and microarrays.
Bionano Genomics develops genome analysis solutions for researchers and clinicians. The company’s stock is listed on the Nasdaq exchange.
In other recent news, Bionano Genomics reported its second-quarter financial results, revealing a total revenue of $6.7 million. This figure marks a 13% decline compared to the previous year, though it shows a slight increase from the first quarter’s $6.5 million. The company also achieved improved gross margins, reaching approximately 52%, which analysts at BTIG found encouraging. H.C. Wainwright responded to these results by raising its price target for Bionano Genomics from $10 to $11, maintaining a Buy rating. BTIG reiterated its Neutral rating, highlighting the company’s focus on core routine users who contribute significantly to flowcell utilization. Despite these developments, Bionano Genomics’ stock experienced a decline in aftermarket trading, indicating ongoing investor concerns. The company’s efforts to enhance its instrument placement outlook were noted positively by analysts. These recent developments illustrate the mixed reactions from the financial community regarding Bionano Genomics’ performance.
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