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.
