Ignite Proteomics Completes Acquisition of PLA Code 0249U for Its Advanced Proteomic Breast Cancer Assay
Ignite Proteomics, a subsidiary of IMAC Holdings (Nasdaq: BACK), has completed the transfer of PLA code 0249U for its proteomic breast cancer assay, previously owned by Theralink Technologies. The code, listed on the Medicare Clinical Laboratory Fee Schedule with a reimbursement rate of $2,219.13, is covered under Palmetto GBA MolDx's 'Proteomics Testing' article (A59636).
The company's proteomic assay measures functional protein activity in breast tumors, offering oncologists data on potential patient responses to targeted therapies. The test is conducted in Ignite's CLIA-certified, CAP-accredited, and NY State-approved laboratory. This acquisition integrates both laboratory capabilities and intellectual property rights, positioning Ignite Proteomics to advance in precision oncology.
Ignite Proteomics, una sussidiaria di IMAC Holdings (Nasdaq: BACK), ha completato il trasferimento del codice PLA 0249U per il suo saggio proteomico sul cancro al seno, precedentemente di proprietà di Theralink Technologies. Il codice, elencato nel Medicare Clinical Laboratory Fee Schedule con una tariffa di rimborso di $2.219,13, è coperto dall'articolo 'Proteomics Testing' di Palmetto GBA MolDx (A59636).
Il saggio proteomico dell'azienda misura l'attività proteica funzionale nei tumori mammari, offrendo agli oncologi dati sulle potenziali risposte dei pazienti alle terapie mirate. Il test viene eseguito nel laboratorio certificato CLIA, accreditato CAP e approvato dallo Stato di New York di Ignite. Questa acquisizione integra sia le capacità di laboratorio che i diritti di proprietà intellettuale, posizionando Ignite Proteomics per avanzare nell'oncologia di precisione.
Ignite Proteomics, una subsidiaria de IMAC Holdings (Nasdaq: BACK), ha completado la transferencia del código PLA 0249U para su ensayo proteómico de cáncer de mama, anteriormente propiedad de Theralink Technologies. El código, listado en el Medicare Clinical Laboratory Fee Schedule con una tasa de reembolso de $2,219.13, está cubierto bajo el artículo de 'Proteomics Testing' de Palmetto GBA MolDx (A59636).
El ensayo proteómico de la compañía mide la actividad proteica funcional en tumores mamarios, ofreciendo a los oncólogos datos sobre las posibles respuestas de los pacientes a las terapias dirigidas. La prueba se realiza en el laboratorio certificado por CLIA, acreditado por CAP y aprobado por el estado de Nueva York de Ignite. Esta adquisición integra tanto las capacidades de laboratorio como los derechos de propiedad intelectual, posicionando a Ignite Proteomics para avanzar en la oncología de precisión.
Ignite Proteomics는 IMAC Holdings(Nasdaq: BACK)의 자회사로서, Theralink Technologies에서 이전에 소유하던 유방암 단백질체 검사에 대한 PLA 코드 0249U의 이전을 완료했습니다. 이 코드는 Medicare 임상 검사실 요금 일정에 등재되어 있으며, $2,219.13의 환급율을 가지고 있으며, Palmetto GBA MolDx의 'Proteomics Testing' 항목(A59636)에 포함되어 있습니다.
회사의 단백질체 검사는 유방 종양에서 기능적 단백질 활동을 측정하여 종양학자들에게 환자의 표적 치료에 대한 잠재적 반응에 대한 데이터를 제공합니다. 이 테스트는 Ignite의 CLIA 인증, CAP 인증 및 뉴욕 주 승인 실험실에서 수행됩니다. 이 인수는 실험실 능력과 지적 재산권을 통합하여 Ignite Proteomics가 정밀 종양학에서 발전할 수 있도록 위치를 잡고 있습니다.
Ignite Proteomics, une filiale d'IMAC Holdings (Nasdaq: BACK), a finalisé le transfert du code PLA 0249U pour son test protéomique du cancer du sein, précédemment détenu par Theralink Technologies. Le code, inscrit au Medicare Clinical Laboratory Fee Schedule avec un taux de remboursement de $2,219.13, est couvert par l'article 'Proteomics Testing' de Palmetto GBA MolDx (A59636).
Le test protéomique de l'entreprise mesure l'activité protéique fonctionnelle dans les tumeurs du sein, fournissant aux oncologues des données sur les réponses potentielles des patients aux thérapies ciblées. Le test est effectué dans le laboratoire certifié CLIA, accrédité par le CAP et approuvé par l'État de New York d'Ignite. Cette acquisition intègre à la fois les capacités de laboratoire et les droits de propriété intellectuelle, positionnant Ignite Proteomics pour progresser dans l'oncologie de précision.
Ignite Proteomics, eine Tochtergesellschaft von IMAC Holdings (Nasdaq: BACK), hat die Übertragung des PLA-Codes 0249U für ihren proteomischen Brustkrebs-Test, der zuvor im Besitz von Theralink Technologies war, abgeschlossen. Der Code ist im Medicare Clinical Laboratory Fee Schedule aufgeführt und hat einen Erstattungsbetrag von $2.219,13. Er wird im Artikel 'Proteomics Testing' von Palmetto GBA MolDx (A59636) abgedeckt.
Der proteomische Test des Unternehmens misst die funktionale Proteinaktivität in Brusttumoren und bietet Onkologen Daten zu potenziellen Patientenreaktionen auf gezielte Therapien. Der Test wird in Ignite's CLIA-zertifiziertem, CAP-akkreditiertem und vom Bundesstaat New York genehmigten Labor durchgeführt. Diese Übernahme integriert sowohl Laborfähigkeiten als auch geistige Eigentumsrechte und positioniert Ignite Proteomics, um in der präzisen Onkologie voranzukommen.
- Secured Medicare reimbursement rate of $2,219.13 per test
- Acquired dedicated PLA code avoiding generic billing codes
- Test conducted in fully accredited laboratory (CLIA, CAP, NY State)
- Clear payment pathway established through MolDx coverage
- None.
Insights
The acquisition of PLA code 0249U represents a significant strategic and financial milestone for IMAC Holdings. The
The established MolDx coverage through Palmetto GBA provides a clear pathway for reimbursement, significantly reducing commercial risks. This is important as approximately
The strategic value extends beyond immediate revenue potential. By acquiring an established code rather than developing a new one, IMAC Holdings bypasses the lengthy code application and pricing determination process, which typically takes 12-18 months. This accelerated market access could provide a significant competitive advantage in the rapidly evolving precision oncology market.
The integration of both laboratory capabilities and intellectual property under one roof streamlines operations and potentially improves margins. This vertical integration model is particularly valuable in the high-complexity diagnostic space, where maintaining quality control and protecting proprietary methods is important for long-term success.
The proteomic assay's ability to measure functional protein activity represents a significant advancement over traditional genomic testing in breast cancer diagnostics. While genomic tests identify genetic potential, protein activity analysis reveals the actual biological processes driving tumor behavior, providing more actionable insights for treatment selection.
This technology addresses a critical gap in current breast cancer diagnostics. Approximately
The CLIA certification, CAP accreditation, and NY State approval demonstrate robust quality standards, which are important for clinical adoption. These certifications typically require extensive validation studies and quality control measures, suggesting the test has already undergone significant clinical validation.
The integration of this technology into IMAC's portfolio could position the company as a leader in next-generation cancer diagnostics. The breast cancer diagnostic market is expected to grow significantly, driven by increasing demand for precision medicine approaches and the limitations of current testing methods.
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
“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
Investors@imacholdings.com
www.igniteproteomics.com
Medicare/Palmetto/MolDx Local Coverage Determination for Proteomic Testing:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=59636
FAQ
What is the Medicare reimbursement rate for BACK's 0249U proteomic breast cancer test?
What certifications does Ignite Proteomics' laboratory have for the breast cancer assay?
How does BACK's proteomic breast cancer assay differ from standard genomic tests?
What is the significance of PLA code 0249U acquisition for BACK shareholders?
