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CARLSBAD, Calif. - Exagen Inc . (NASDAQ: NASDAQ:XGN), a provider specializing in autoimmune diagnostics, has announced the validation and regulatory submission for approval of new biomarkers aimed at improving the diagnosis of Systemic Lupus Erythematosus (SLE) and rheumatoid arthritis (RA). These biomarkers are set to enhance the company's AVISE CTD test platform, which assists clinicians in diagnosing connective tissue diseases (CTD).
The newly introduced biomarkers are expected to provide greater diagnostic clarity for SLE and RA, conditions that often present with overlapping symptoms, making accurate diagnosis challenging. The AVISE CTD platform, which has been aiding rheumatologists since 2012, will now include a T Cell Lupus profile with three new T Cell biomarkers (TC4d, TIgG, TIgM), offering enhanced sensitivity for SLE. Additionally, the RA profile will be expanded with four biomarkers (anti-CarP and anti-RA33 biomarkers IgA, IgG, IgM), which are designed to help identify patients with RA more confidently, including those with seronegative RA.
John Aballi, CEO of Exagen, emphasized that the enhancements are part of the company's commitment to developing solutions for clinicians who face difficulties in diagnosing suspected autoimmune patients. Vasileios Kyttaris, MD, PhD, FACR, also highlighted the importance of these biomarkers in providing a clearer window into patient health, which may lead to more definitive diagnoses.
The AVISE CTD test, trusted by rheumatologists, covers several CTDs, including SLE, Sjögren's Disease, Mixed Connective Tissue Disease (MCTD), Antiphospholipid Syndrome, Myositis, Systemic Sclerosis, Graves' Disease, and Hashimoto's Thyroiditis. The addition of the new biomarkers represents a significant milestone for Exagen and those working with suspected autoimmune patients.
The availability of these enhancements is pending conditional approval by the New York State Department of Health. Exagen, headquartered in San Diego County, California, is dedicated to providing clarity in autoimmune disease decision-making and improving clinical outcomes through its innovative testing portfolio.
This announcement is based on a press release statement from Exagen Inc. and reflects the company's ongoing efforts to advance in the field of autoimmune diagnostics.
"In other recent news, Exagen Inc. reported its third quarter financial results for 2024, showcasing strategic progress and growth. The company's total revenue reached $12.5 million for the quarter, despite a one-time adjustment of $1.2 million. Year-to-date revenue rose to $42 million, marking an 8% increase from the previous year, largely driven by a 45% surge in average selling price. The adjusted EBITDA loss showed a substantial improvement, with a more than 70% reduction compared to the same period in 2023.
Exagen Inc. ended the quarter with $22 million in cash and cash equivalents. The company is projecting full-year 2024 revenue to fall between $55 million and $56 million. Despite a decrease in the gross margin for Q3 to 55.8% from 57.4% in 2023 and the impact of hurricanes on operations, the company is optimistic about achieving cash flow positivity by the end of 2025.
In other developments, the company is planning for the launch of new proprietary biomarkers and has taken significant steps to improve operational efficiency. These recent developments are part of Exagen's strategic growth plan and its path to profitability."
InvestingPro Insights
Exagen Inc.'s (NASDAQ: XGN) recent announcement of new biomarkers for its AVISE CTD test platform aligns with the company's focus on innovation in autoimmune diagnostics. This development could potentially impact Exagen's financial performance and market position.
According to InvestingPro data, Exagen's revenue for the last twelve months as of Q3 2023 stood at $55.75 million, with a revenue growth of 8.0% over the same period. This growth trajectory could be further supported by the introduction of these new biomarkers, which may enhance the company's product offering and market appeal.
InvestingPro Tips highlight that Exagen operates with a moderate level of debt and has liquid assets exceeding short-term obligations. These factors could provide the company with financial flexibility to invest in research and development initiatives like the recently announced biomarkers.
However, it's important to note that Exagen is not currently profitable, with a negative operating income of $15.4 million for the last twelve months as of Q3 2023. This aligns with another InvestingPro Tip indicating that analysts do not anticipate the company to be profitable this year.
Despite the current lack of profitability, Exagen has shown a strong market performance. The company's stock has seen a significant price uptick of 56.25% over the last six months, and a 61.76% return over the past year, as reported by InvestingPro. This positive market sentiment could be attributed to investor confidence in Exagen's growth potential and innovative product pipeline.
For investors seeking a more comprehensive analysis, InvestingPro offers additional insights with 7 more tips available for Exagen Inc., providing a deeper understanding of the company's financial health and market position.
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