Ignite Proteomics Completes Acquisition of PLA Code 0249U for Its Advanced Proteomic Breast Cancer Assay

Key Takeaways:

• Ignite Proteomics acquired PLA code 0249U, crucial for its breast cancer assay.
• The code is listed on Medicare’s fee schedule with reimbursement of $2,219.13.
• The assay measures functional protein activity, offering insights beyond genomic tests.
• Conducted in accredited laboratories, ensuring high-quality standards.
• Positions Ignite Proteomics to accelerate innovation in precision oncology.

Ignite Proteomics Completes Acquisition of Essential Medicare Code

A Milestone in Precision Oncology

Ignite Proteomics LLC, a subsidiary of IMAC Holdings, Inc. (Nasdaq: BACK), has announced the successful transfer of Proprietary Laboratory Analyses (PLA) code 0249U to its portfolio. Originally issued to Theralink Technologies, Inc., this code is now fully under Ignite Proteomics, marking a significant step in the company’s mission to advance personalized cancer diagnostics.

The Significance of PLA Code 0249U

PLA codes like 0249U are essential building blocks for new diagnostics. They solidify assay recognition within payers’ billing systems and represent a significant step in test validation. According to the Centers for Medicare & Medicaid Services (CMS), code 0249U is reimbursed at $2,219.13 on the Medicare Clinical Laboratory Fee Schedule (CLFS), reinforcing its position among high-complexity diagnostic assays.

Advancing Breast Cancer Diagnostics

Ignite’s proteomic assay measures functional protein activity in breast tumors. Unlike standard genomic tests that only analyze genetic information, this method identifies which proteins are truly “active” in tumors. This provides oncologists with critical data on how patients might respond to targeted therapies, potentially improving outcomes for those who may not benefit from one-size-fits-all treatments.

“Cementing Our Leadership in Proteomics”

“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.”

Quality and Compliance at the Forefront

The test is conducted in Ignite’s Clinical Laboratory Improvement Amendments (CLIA)-certified, College of American Pathologists (CAP)-accredited, and New York State–approved laboratory. These accreditations ensure that the assay meets stringent quality standards, providing reliable results for clinicians and patients.

Simplifying Reimbursement and Coverage

Many emerging tests without a dedicated code must rely on generic billing codes, which often create reimbursement and coverage hurdles. By obtaining a unique PLA code recognized and priced by Medicare and linked to coverage established by Medicare’s contractor, Ignite’s assay avoids these challenges. This facilitates easier understanding and coverage by doctors and insurers, potentially increasing patient access to personalized breast cancer treatment.

Positioned for Future Innovation

By leveraging the established PLA code, Ignite Proteomics aims to expand awareness and accelerate the adoption of its advanced proteomic assay. The integration of both the laboratory capabilities and intellectual property positions the company at the forefront of precision oncology.

About Ignite Proteomics

Ignite Proteomics LLC specializes in advanced Reverse Phase Protein Array (RPPA) technology for cancer diagnostics. Operating under a CLIA-certified, CAP-accredited, and New York 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.

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., doing business as Ignite Sciences, Inc.

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