Exagen's New Lupus and RA Biomarkers: A Game Changer in Autoimmune Diagnostics

Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, has secured conditional approval from the New York State Department of Health for new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays. The company plans to launch these innovative tests commercially in January 2025, further enhancing its AVISE CTD platform and solidifying its position in the autoimmune diagnostics market. Additionally, Exagen announced select preliminary financial results for the full year 2024, highlighting record revenue and improvements in adjusted EBITDA and cash burn.

The new biomarkers, which include a T-Cell Lupus profile (TC4d, TIgG, TIgM) and an enhanced RA profile (anti-CarP and anti-RA33 biomarkers IgA, IgG, IgM), will significantly improve the clinical utility of AVISE CTD. These biomarkers provide enhanced sensitivity for SLE and RA, respectively, enabling clinicians to more confidently identify patients with these conditions. The T-Cell Lupus profile complements the existing AVISE Lupus profile, offering a more comprehensive diagnosis, particularly in clinically ambiguous cases. The enhanced RA profile addresses the challenge of seronegative RA diagnosis, where traditional markers often fail to detect the disease.



The conditional approval of these new biomarkers by the New York State Department of Health enables Exagen to launch them commercially in January 2025. This timely approval allows Exagen to capitalize on the growing demand for autoimmune diagnostics and the need for more accurate and efficient diagnostic tools. The company's commitment to continuous innovation and improvement in autoimmune diagnostic testing sets it apart from competitors and strengthens its position in the specialized diagnostics sector.

Exagen's preliminary unaudited select financial results for the full year 2024 indicate strong operational execution with record-setting metrics. Notable highlights include:

* Record full-year 2024 revenue of $55.3-$55.8 million
* AVISE CTD trailing 12-month average selling price (ASP) of $408-$412, representing a $72-$76 improvement YoY
* Significant adjusted EBITDA improvement of 37-43% compared to 2023
* Net neutral cash usage in the fourth quarter of 2024, with a cash balance of $22.2 million



The combination of NY State approval for new lupus and RA biomarkers and strong financial metrics creates multiple growth catalysts for Exagen in 2025. The improved reimbursement metrics and ASP growth indicate strong payer acceptance and market demand, further validating the company's potential for market share and revenue growth. With autoimmune diseases affecting over 24 million Americans and diagnostic challenges persisting, Exagen's enhanced testing capabilities address a substantial unmet need while strengthening its competitive moat in the specialized diagnostics sector.

In conclusion, Exagen's new lupus and RA biomarkers, along with its strong financial performance, position the company to capture immediate market share in the autoimmune testing market. The company's commitment to innovation, improved reimbursement metrics, and strong payer acceptance create multiple growth catalysts for 2025. As autoimmune diseases continue to impact a significant number of Americans, Exagen's enhanced testing capabilities address a substantial unmet need, solidifying its competitive position in the specialized diagnostics sector.