Bionano Genomics Announces New CPT Code for OGM
Bionano Laboratories, the dedicated testing arm of Bionano Genomics, Inc. (NASDAQ: BNGO), has made an impactful stride in genetic testing with its announcement of a preliminary payment determination by the Centers for Medicare & Medicaid Services (CMS). This determination introduces a Category I Current Procedural Terminology (CPT) code, crucial for the reimbursement of tests utilizing optical genome mapping (OGM) for analyzing constitutional genetic disorders.
Significance of the New CPT Code
The newly established CPT code represents a pivotal advancement in the laboratory diagnostics landscape. It is a recognition of OGM's efficacy in identifying structural and copy number variations linked to genetic disorders, thereby enhancing laboratory-developed tests (LDTs) as an alternative to traditional methods such as microarrays and karyotyping. Now priced at $1263.53, the CPT code is a $363.53 increase compared to microarray-related codes, establishing a strong precedent for the reimbursement of cutting-edge genetic testing methodologies.
Implications for Laboratories
With this new coding, laboratories using the OGM technology, such as Bionano Laboratories, now have greater assurance of reimbursement for tests that are instrumental in diagnostics. The new code, known as 81354, complements the previously released 81195 code for hematologic malignancy analysis. Both are expected to be leveraged for their respective diagnostic applications and thus significantly broaden the scope of genetic disorder analysis.
Bionano's Offerings
Bionano Labs offers products such as the OGM-Dx™ Postnatal Whole Genome SV and OGM-Dx™ Prenatal Whole Genome SV, which will soon be governed under this new code. This suggests that accurate and expansive genetic testing will become more accessible, especially for conditions associated with developmental delays, autism spectrum disorders, and intellectual disabilities. The laboratory's focus on addressing critical healthcare needs aligns with this transition.
The Vision of Bionano Laboratories
The implementation of this CPT code is a key step in Bionano's mission to transform genome analysis practices worldwide. Bionano's chief medical officer, Alka Chaubey, expressed optimism about how this new CPT designation enables laboratories to pivot towards modern testing methods that surpass traditional approaches. The recognition of OGM's capabilities in clinical settings not only fosters innovation in genetic testing but also promotes its adoption globally.
Advantage of OGM Technology
OGM offers laboratories an advanced platform for genomic analysis, allowing for a detailed examination of the genome that legacy cytogenetic methods may not achieve. By offering both clinical diagnostics and comprehensive research services, Bionano is positioned at the forefront of genetic testing technology. This new CPT code only further solidifies its status in the diagnostic arena.
About Bionano Genomics
Bionano Genomics is committed to unlocking the mysteries of the genome by providing innovative genomic analysis solutions. The company focuses on optical genome mapping to assist researchers and clinicians worldwide, enhancing their understanding of complex genetic questions. This ambition fuels ongoing developments in both diagnostic testing and software solutions for diverse research applications spanning from clinical to basic studies.
Frequently Asked Questions
What is the significance of the new CPT code introduced by Bionano?
The new CPT code is significant as it facilitates reimbursement for tests utilizing optical genome mapping technology, making cutting-edge genetic testing more accessible.
How does the new CPT code compare to previous codes?
The new CPT code is priced higher than previous microarray codes, reflecting the advanced capabilities of optical genome mapping in detecting genetic disorders.
What are the applications of Bionano's OGM-based testing?
Bionano's OGM-based testing is applied in various settings, particularly for diagnosing developmental delays, autism, and intellectual disabilities.
What does Bionano Laboratories focus on?
Bionano Laboratories focuses on utilizing advanced genomic technologies to provide accurate genetic testing and comprehensive support in diagnostics and research.
Who can benefit from the advancements in OGM technology?
Clinicians, researchers, and patients can benefit from the advancements in OGM technology as it enhances the ability to analyze complex genetic questions effectively.
