Ignite Proteomics Completes Acquisition of PLA Code 0249U for Its Advanced Proteomic Breast Cancer Assay
Golden, CO, Feb. 19, 2025 (GLOBE NEWSWIRE) -- Ignite Proteomics LLC, a subsidiary of IMAC Holdings, Inc. (NASDAQ:BACK), today announced the completed transfer of Proprietary Laboratory Analyses (PLA) code 0249U – originally issued to Theralink Technologies, Inc. – to Ignite Proteomics LLC. The AMA CPT code is listed on the Medicare Clinical Laboratory Fee Schedule (CLFS) and is addressed by the Palmetto GBA MolDx "Proteomics Testing" article (A59636). This milestone integrates both the laboratory capability and the owned and licensed intellectual property of the proteomic breast cancer assay into Ignite Proteomics.
PLA codes like 0249U are essential building blocks for new diagnostics, as they solidify assay recognition within payers' billing systems and often represent a significant step in test validation. According to CMS' most recent CLFS data, 0249U is reimbursed at $2,219.13, reinforcing its position among high-complexity diagnostic assays.
"We are thrilled with this culmination of our efforts to integrate both the proprietary lab capabilities and the intellectual property underlying PLA code 0249U into Ignite Proteomics," said Faith Zaslavsky, CEO of Ignite Proteomics and IMAC Holdings. "This milestone cements our leadership in proteomic diagnostics and positions us to accelerate innovation in precision oncology."
Ignite's proteomic assay, now covered by 0249U, measures functional protein activity in breast tumors. Unlike standard genomic tests, this method can identify which proteins are truly "active," offering oncologists data on how patients might respond to targeted therapies. The test is conducted in Ignite's CLIA-certified, CAP-accredited, and NY State–approved laboratory, ensuring it meets stringent quality standards.
Key Elements of the Transaction
- Transfer of 0249U PLA Code: Originally assigned to Theralink Technologies, the code is now fully under IMAC Holdings and Ignite Proteomics.
- Medicare CLFS Pricing: Approximately $2,219 is listed for 0249U, signifying a robust valuation that supports test adoption in clinical practice.
- MolDx Coverage Article A59636: The Palmetto GBA MolDx "Proteomics Testing" (A59636) outlines billing guidance and coverage criteria for proteomic assays, further clarifying the payment pathway.
Many emerging tests without a dedicated code must rely on generic billing codes such as 81479 (unlisted molecular pathology) or 81599 (unlisted multi-analyte assay with algorithmic analyses), which often create reimbursement and coverage hurdles. By having its own PLA code, Ignite's assay avoids the confusion of "unlisted" categories and ensures payers can quickly understand and reimburse the specific test.
By leveraging this established PLA code, Ignite Proteomics aims to expand awareness and accelerate the adoption of its advanced proteomic assay for breast cancer. The approach measures key proteins and pathways that influence how tumors respond to targeted drugs, potentially improving outcomes for patients who may not benefit from one-size-fits-all treatments.
About Ignite Proteomics
Ignite Proteomics LLC, a subsidiary of IMAC Holdings, specializes in advanced Reverse Phase Protein Array (RPPA) technology for cancer diagnostics. Operating under a CLIA-certified, CAP-accredited, and NY State–approved laboratory, Ignite's proteomic assays bridge a gap often left by gene-focused methods, helping physicians match patients with the most suitable targeted therapies. Several key markers measured in Ignite's assays are protected by licensed patents.
About IMAC Holdings, Inc.
IMAC Holdings, Inc. strives to improve patient outcomes through innovative healthcare solutions. By combining strategic acquisitions and pioneering technologies, IMAC remains committed to advancing personalized medicine. IMAC Holdings has begun the process to change its name and will soon be shown as IMAC Holdings, Inc., DBA Ignite Sciences, Inc.
Forward-Looking Statements
Certain statements made in this release may constitute "forward-looking statements" within the meaning of federal securities laws. Actual results may differ materially from those expressed or implied herein due to risks and uncertainties. We undertake no obligation to update forward-looking statements except as required by law.
Non-Scientific Summary
Many traditional tests only look at a cancer's genes, but Ignite's proteomic method checks if certain proteins in breast tumors are actually "turned on" and also measures many different protein biomarkers at once. By obtaining a unique billing code, recognized and priced by Medicare and linked to coverage established by Medicare's contractor that covers this type of testing, it's easier for doctors and insurers to understand and cover this test. That means more patients can potentially access a personalized approach to breast cancer treatment.
Contact Information
[email protected]
www.igniteproteomics.com
Medicare/Palmetto/MolDx Local Coverage Determination for Proteomic Testing:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=59636
