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Exagen Inc. Achieves Key Milestone with 1,000,000th Patient Tested by AVISE® CTD

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Exagen Inc. has announced a significant milestone with the completion of its 1,000,000th AVISE CTD test, highlighting the test's widespread adoption in the rheumatologic community. The AVISE CTD test, launched in 2012, provides clinicians with important information for accurately diagnosing autoimmune and connective tissue diseases (CTD), offering superior accuracy compared to traditional screening methods.

The test's unique biomarkers enable confident and quick diagnosis of various CTDs, addressing the challenge of increasing autoimmune disease incidence. The milestone is supported by extensive peer-reviewed literature validating the test's clinical validity and utility in patient care.

Exagen Inc. ha annunciato un traguardo significativo con il completamento del suo 1.000.000° test AVISE CTD, evidenziando l'ampia adozione del test nella comunità reumatologica. Il test AVISE CTD, lanciato nel 2012, fornisce ai clinici informazioni importanti per diagnosticare con precisione le malattie autoimmuni e del tessuto connettivo (CTD), offrendo una maggiore accuratezza rispetto ai metodi di screening tradizionali.

I biomarcatori unici del test consentono una diagnosi rapida e sicura di vari CTD, affrontando così la sfida dell'aumento dell'incidenza delle malattie autoimmuni. Il traguardo è supportato da una vasta letteratura sottoposta a revisione paritaria che valida la validità clinica e l'utilità del test nella cura dei pazienti.

Exagen Inc. ha anunciado un hito significativo con la finalización de su 1,000,000 ° prueba AVISE CTD, destacando la amplia adopción de la prueba en la comunidad reumatológica. La prueba AVISE CTD, lanzada en 2012, proporciona a los clínicos información importante para diagnosticar con precisión enfermedades autoinmunes y del tejido conectivo (CTD), ofreciendo una mayor precisión en comparación con los métodos de detección tradicionales.

Los biomarcadores únicos de la prueba permiten un diagnóstico rápido y seguro de varios CTD, abordando el desafío del aumento de la incidencia de enfermedades autoinmunes. El hito está respaldado por una extensa literatura revisada por pares que valida la validez clínica y la utilidad de la prueba en el cuidado de los pacientes.

Exagen Inc.1,000,000번째 AVISE CTD 테스트 완료를 발표하며, 이는 류머티즘 커뮤니티에서의 테스트의 광범위한 채택을 강조합니다. 2012년 출시된 AVISE CTD 테스트는 임상의에게 자가면역 질환 및 결합 조직 질환(CTD)을 정확하게 진단하는 데 중요한 정보를 제공하며, 전통적인 선별 방법에 비해 높은 정확도를 자랑합니다.

테스트의 독특한 바이오마커는 다양한 CTD에 대한 신뢰할 수 있고 빠른 진단을 가능하게 하여 자가면역 질환의 증가하는 발생률이라는 과제를 해결합니다. 이 이정표는 테스트의 임상적 유효성과 환자 치료에서의 효용성을 검증하는 방대한 동료 검토 문헌에 의해 뒷받침됩니다.

Exagen Inc. a annoncé une étape significative avec l'achèvement de son 1 000 000e test AVISE CTD, soulignant l'adoption généralisée de ce test au sein de la communauté rhumatologique. Lancé en 2012, le test AVISE CTD fournit aux cliniciens des informations importantes pour diagnostiquer avec précision les maladies auto-immunes et du tissu conjonctif (CTD), offrant une précision supérieure par rapport aux méthodes de dépistage traditionnelles.

Les biomarqueurs uniques du test permettent un diagnostic rapide et fiable de plusieurs CTD, répondant ainsi au défi de l'augmentation de l'incidence des maladies auto-immunes. Ce jalon est soutenu par une vaste littérature examinée par des pairs, validant la validité clinique et l'utilité du test dans les soins aux patients.

Exagen Inc. hat einen bedeutenden Meilenstein mit dem Abschluss des 1.000.000. AVISE CTD-Tests bekannt gegeben, was die weitreichende Akzeptanz des Tests in der rheumatologischen Gemeinschaft hervorhebt. Der 2012 eingeführte AVISE CTD-Test liefert Kliniken wichtige Informationen, um autoimmune und Bindegewebserkrankungen (CTD) genau zu diagnostizieren, und bietet eine höhere Genauigkeit im Vergleich zu traditionellen Screening-Methoden.

Die einzigartigen Biomarker des Tests ermöglichen eine sichere und schnelle Diagnose verschiedener CTD und nehmen damit die Herausforderung des zunehmenden Auftretens von Autoimmunerkrankungen an. Der Meilenstein wird von umfangreicher peer-reviewter Literatur unterstützt, die die klinische Gültigkeit und Nützlichkeit des Tests in der Patientenversorgung bestätigt.

Positive
  • Reached significant milestone of 1,000,000 AVISE CTD tests completed
  • Demonstrated strong market adoption since 2012 launch
  • Backed by extensive peer-reviewed literature supporting clinical validity
Negative
  • None.

Insights

The milestone of 1 million AVISE CTD tests is more symbolic than financially impactful in the immediate term. While it demonstrates market penetration and physician adoption since the test's 2012 launch, the announcement lacks specific revenue figures or growth metrics that would signal material financial impact. The test's clinical utility in autoimmune disease diagnosis is well-documented through peer-reviewed literature, but without context about test pricing, reimbursement rates, or market share gains, the news primarily serves as a marketing milestone rather than a significant financial catalyst.

The growing incidence of autoimmune conditions suggests a expanding market opportunity, but investors would need data on conversion rates, competitive positioning and revenue per test to properly assess the business impact. The company's $75M market cap suggests room for growth if AVISE CTD can capture more market share, but this milestone alone doesn't provide enough financial substance to move the needle significantly.

The milestone demonstrates AVISE CTD’s value and adoption within the rheumatologic community, clearly demonstrating superior laboratory testing for improved patient care

CARLSBAD, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Exagen Inc., a leading provider of autoimmune testing, today announced the completion of its 1,000,000th AVISE CTD test, marking a significant milestone that underscores the company’s dedication to supporting patients and clinicians managing connective tissue diseases (CTD) and other autoimmune conditions.

AVISE CTD provides clinicians with critical information to accurately diagnose autoimmune and connective tissue diseases. Traditional screening methods often lack accuracy, resulting in repeat testing and delayed diagnosis. With significant increases in autoimmune incidence in recent years, AVISE CTD provides unique biomarkers that empower clinicians to confidently and quickly diagnose various CTDs.

“Aiding in the care of our 1,000,000th patient is a huge milestone for our organization and demonstrates the value and utility that AVISE CTD provides in the care of patients with suspected autoimmune disease. We are very proud of reaching this level of adoption and look forward to continuing to support the rheumatologic community with future innovations,” said John Aballi, President and CEO of Exagen.

Since launching AVISE CTD in 2012, Exagen has produced an extensive body of peer-reviewed literature supporting the test’s clinical validity and utility. These publications and the 1,000,000th completed test demonstrate the importance of AVISE CTD in patient care.

Learn more about AVISE CTD and its unique ability to provide 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.

Investors:
Ryan Douglas
Exagen Inc.
ir@exagen.com
760.560.1525


FAQ

What milestone did Exagen (XGN) achieve with its AVISE CTD test in December 2024?

Exagen reached its 1,000,000th AVISE CTD test completion, marking a significant milestone in autoimmune testing.

When was the AVISE CTD test first launched by Exagen (XGN)?

The AVISE CTD test was launched by Exagen in 2012.

What medical conditions does Exagen's (XGN) AVISE CTD test diagnose?

The AVISE CTD test diagnoses autoimmune and connective tissue diseases (CTD) through unique biomarkers.

How does Exagen's (XGN) AVISE CTD test compare to traditional screening methods?

AVISE CTD provides superior accuracy compared to traditional screening methods, which often require repeat testing and result in delayed diagnosis.

Exagen Inc.

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