Exagen Inc. Completes Validation and Regulatory Submission for New Lupus and Rheumatoid Arthritis Biomarkers on the AVISE® CTD Platform
Exagen has completed validation and submitted regulatory approval for new biomarkers to enhance its AVISE CTD platform, which aids in diagnosing autoimmune diseases. The enhancement includes seven new biomarkers: three T Cell biomarkers for improved Systemic Lupus Erythematosus (SLE) sensitivity, and four biomarkers for better rheumatoid arthritis (RA) diagnosis. AVISE CTD, operational since 2012, helps diagnose various connective tissue diseases where symptoms overlap, making differential diagnosis challenging. The platform's enhancement aims to provide clearer diagnostic information, potentially reducing repeat testing and improving patient outcomes.
Exagen ha completato la validazione e presentato la richiesta di approvazione normativa per nuovi biomarcatori che migliorano la sua piattaforma AVISE CTD, la quale aiuta nella diagnosi delle malattie autoimmuni. Il miglioramento include sette nuovi biomarcatori: tre biomarcatori per le cellule T per una maggiore sensibilità nel lupus eritematoso sistemico (LES), e quattro biomarcatori per una migliore diagnosi dell’artrite reumatoide (AR). La AVISE CTD, operativa dal 2012, aiuta a diagnosticare varie malattie del tessuto connettivo in cui i sintomi si sovrappongono, rendendo la diagnosi differenziale una sfida. L’aggiornamento della piattaforma mira a fornire informazioni diagnostiche più chiare, riducendo potenzialmente i test ripetuti e migliorando gli esiti dei pazienti.
Exagen ha completado la validación y presentado la aprobación regulatoria para nuevos biomarcadores que mejoran su plataforma AVISE CTD, la cual ayuda a diagnosticar enfermedades autoinmunes. La mejora incluye siete nuevos biomarcadores: tres biomarcadores de células T para una mayor sensibilidad en el lupus eritematoso sistémico (LES) y cuatro biomarcadores para un mejor diagnóstico de la artritis reumatoide (AR). La AVISE CTD, en funcionamiento desde 2012, ayuda en el diagnóstico de diversas enfermedades del tejido conectivo donde los síntomas se superponen, lo que dificulta el diagnóstico diferencial. La mejora de la plataforma tiene como objetivo proporcionar información diagnóstica más clara, lo que podría reducir las pruebas repetidas y mejorar los resultados para los pacientes.
Exagen은 새로운 바이오마커의 유효성을 검증하고 자가면역질환 진단을 지원하는 AVISE CTD 플랫폼에 대한 규제 승인을 제출했습니다. 이 향상에는 세 가지 T세포 바이오마커(전신 홍반 루푸스, SLE의 민감도를 향상)와 류umatoid arthritis(RA) 진단을 개선하기 위한 네 가지 바이오마커를 포함하여 총 일곱 개의 새로운 바이오마커가 포함됩니다. AVISE CTD는 2012년부터 운영되고 있으며, 증상이 겹치는 다양한 결합조직질환의 진단을 지원하여 차별 진단을 어렵게 만듭니다. 플랫폼 개선의 목적은 더 명확한 진단 정보를 제공하여 재검사를 줄이고 환자의 결과를 개선하는 것입니다.
Exagen a finalisé la validation et soumis la demande d'approbation réglementaire pour de nouveaux biomarqueurs visant à améliorer sa plateforme AVISE CTD, qui aide au diagnostic des maladies auto-immunes. Cette amélioration comprend sept nouveaux biomarqueurs : trois biomarqueurs des cellules T pour une sensibilité accrue dans le lupus érythémateux disséminé (LED), et quatre biomarqueurs pour un meilleur diagnostic de l'arthrite rhumatoïde (AR). La AVISE CTD, opérationnelle depuis 2012, aide à diagnostiquer diverses maladies du tissu conjonctif dont les symptômes se chevauchent, rendant le diagnostic différentiel difficile. L'amélioration de la plateforme vise à fournir des informations diagnostiques plus claires, ce qui pourrait réduire les tests répétés et améliorer les résultats pour les patients.
Exagen hat die Validierung abgeschlossen und die behördliche Genehmigung für neue Biomarker eingereicht, um die AVISE CTD-Plattform zu verbessern, die bei der Diagnose von Autoimmunerkrankungen hilft. Die Verbesserung umfasst sieben neue Biomarker: drei T-Zell-Biomarker für eine verbesserte Sensitivität bei systemischem Lupus erythematodes (SLE) und vier Biomarker für eine bessere Diagnose von rheumatoider Arthritis (RA). Die AVISE CTD ist seit 2012 im Einsatz und hilft bei der Diagnose verschiedener Bindegewebserkrankungen, bei denen sich die Symptome überschneiden, was die differentialdiagnostische Abgrenzung erschwert. Die Verbesserung der Plattform zielt darauf ab, klarere diagnostische Informationen bereitzustellen, um möglicherweise wiederholte Tests zu reduzieren und die Behandlungsergebnisse für die Patienten zu verbessern.
- Enhanced diagnostic capabilities with seven new biomarkers for SLE and RA detection
- Potential reduction in healthcare costs by minimizing repeat testing
- Improved ability to identify seronegative RA cases
- Pending regulatory approval from New York State Department of Health
- Current version may require updates, potentially affecting existing testing procedures
Insights
The validation and regulatory submission of 7 new biomarkers for Exagen's AVISE CTD platform represents a significant advancement in autoimmune diagnostics. The platform's enhancement with 3 T Cell biomarkers for lupus and 4 biomarkers for rheumatoid arthritis could substantially improve diagnostic accuracy and reduce time to diagnosis.
The expanded test panel addresses a critical market need, as early and accurate diagnosis of autoimmune conditions can significantly impact patient outcomes and healthcare costs. The T Cell Lupus profile offers enhanced sensitivity compared to conventional markers, while the RA profile improvements could help identify seronegative RA cases that are typically challenging to diagnose.
This development could strengthen Exagen's market position in the
Significant enhancements will equip clinicians with even more diagnostic clarity in the treatment of patients with autoimmune disease
CARLSBAD, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Exagen Inc., a leading provider of autoimmune testing, today announced the validation and regulatory submission for approval of new Systemic Lupus Erythematosus (SLE) and rheumatoid arthritis (RA) biomarkers, to be incorporated into the AVISE CTD platform. Collectively, these new biomarkers will further improve the clinical utility of AVISE CTD, providing clinicians with the information they need to definitively diagnose patients and shorten their autoimmune diagnostic journeys.
Since 2012, AVISE CTD has delivered diagnostic clarity where overlapping clinical symptoms and ambiguous disease states make it difficult to arrive at a differential diagnosis of a connective tissue disease (CTD). A lack of diagnostic clarity may lead to serial and repeat testing, increased morbidity, worsening mortality rates and growing healthcare costs.
“The AVISE CTD enhancements are a direct result of our continuing commitment to develop and deliver testing solutions that address the challenges of clinicians searching for answers for suspected autoimmune patients,” said John Aballi, CEO, Exagen. “These coming enhancements exemplify how Exagen is raising the bar for autoimmune diagnostic testing while also empowering clinicians to deliver better patient care.”
The seven new biomarkers for AVISE CTD are as follows:
- A new T Cell Lupus profile will include three new T Cell biomarkers (TC4d, TIgG, TIgM).
These provide enhanced sensitivity for SLE as compared to conventional SLE biomarkers and serve as a complement to the AVISE Lupus profile also included in the test.
- The RA profile will be enhanced with the addition of four biomarkers (anti-CarP and anti-RA33 biomarkers IgA, IgG, IgM).
Providers are given more data to confidently identify patients with RA and substantiate a seronegative RA diagnosis.
The AVISE CTD test that rheumatologists have come to know and trust is composed of multiple biomarker assays that assist in the clinical diagnosis of the most common CTDs, which included:
- SLE
- RA
- Sjögren's Disease
- Mixed Connective Tissue Disease (MCTD)
- Antiphospholipid Syndrome
- Myositis
- Systemic Sclerosis
- Graves’ Disease
- Hashimoto’s Thyroiditis
“The addition of these biomarkers to the AVISE CTD test is an important milestone for those of us working with suspected autoimmune patients,” said Vasileios Kyttaris, MD, PhD, FACR. “We as clinicians now have an even clearer window into each individual patient’s health, which in turn may lead to a more definitive diagnosis.”
Availability of the AVISE CTD test enhancements are pending conditional approval by the New York State Department of Health. Learn more about AVISE CTD and its ability to provide unique diagnostic clarity.
About Exagen Inc.
Exagen Inc. (Nasdaq: XGN) is a leading provider of autoimmune diagnostics, committed to transforming care for patients with chronic and debilitating autoimmune conditions. Based in San Diego County, Calif., Exagen’s mission is to provide clarity in autoimmune disease decision making and improve clinical outcomes through its innovative testing portfolio. The company’s flagship product, AVISE® CTD, enables clinicians to more effectively diagnose complex autoimmune conditions such as lupus, rheumatoid arthritis, and Sjögren’s disease earlier and with greater accuracy. Exagen’s laboratory specializes in the testing of rheumatic diseases, delivering precise and timely results, supported by a full suite of AVISE-branded tests for disease diagnosis, prognosis, and monitoring. With a focus on research, innovation, education, and patient-centered care, Exagen is dedicated to addressing the ongoing challenges of autoimmune disease management. For more information, visit Exagen.com or follow @ExagenInc on X.
Forward Looking Statements
Exagen cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Exagen's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Exagen that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Exagen’s business, including, without limitation Exagen’s goals, strategies and ambitions; potential future financial and business performance; the potential for Exagen’s research to lead to positive impacts to patients; the potential for Exagen’s research to lead to new or improved testing products; the potential utility and effectiveness of Exagen’s services and testing solutions; the potential value of updates being made to AVISE® CTD; potential shareholder value and growth and 2024 guidance. The inclusion of forward-looking statements should not be regarded as a representation by Exagen that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Exagen’s business, including, without limitation: delays in reimbursement and coverage decisions from Medicare and third-party payors and in interactions with regulatory authorities, and delays in ongoing and planned clinical trials involving its tests; changes in laws and regulations related to Exagen’s regulatory requirements; Exagen’s commercial success depends upon attaining and maintaining significant market acceptance of its testing products among rheumatologists, patients, third-party payors and others in the medical community; Exagen’s ability to successfully execute on its business strategies; third-party payors not providing coverage and adequate reimbursement for Exagen’s testing products, including Exagen’s ability to collect on funds due; Exagen’s ability to obtain and maintain intellectual property protection for its testing products; regulatory developments affecting Exagen’s business; and other risks described in Exagen’s prior press releases and Exagen’s filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in Exagen’s Annual Report on Form 10-K for the year ended December 31, 2023 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Exagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Ryan Douglas
Exagen Inc.
ir@exagen.com
760.560.1525
FAQ
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