Progentec Diagnostics Cuts Lupus Classification Timeline by 80% In Virtual Study

Findings presented at LUPUS 2025 show virtual SLE Classification Program (PROACTIVE^™) classified SLE cases in just over one year versus traditional five-to-seven-year timeline

OKLAHOMA CITY, May 27, 2025 /PRNewswire/ -- Progentec Diagnostics, a leader in advanced diagnostics and digital health solutions for autoimmune conditions, today announced breakthrough findings from its virtual lupus classification study at the LUPUS 2025 conference. The fully digital, technology-enabled program successfully identified systemic lupus erythematosus (SLE) patients in approximately one year—significantly shortening the traditional five-to-seven-year diagnostic journey. The results presented at the meeting have been published in The Journal of Rheumatology May 21 2025, 52 (Suppl 1) 214 (DOI: https://doi.org/10.3899/jrheum.2025-0390.PV217).

"This study showed that participants who ultimately met SLE classification criteria were identified in just over one year—compared to the traditional timeline typically required," said Dr. Timothy Niewold, MD, Director, Barbara Volcker Center for Women and Rheumatic Disease and one of the rheumatology specialists that evaluated study participants. "This virtual model represents a transformative approach to improving early access to care for those living with lupus."

SLE, commonly known as lupus, is a chronic autoimmune disease that can damage multiple organ systems and significantly impact quality of life. Historically, patients face a years-long diagnostic odyssey involving numerous healthcare provider visits, conflicting opinions, and delayed treatment initiation, all leading to poor clinical outcomes and significant resource utilization over time.

The digital study leveraged Progentec's publicly accessible online screening portal Autoimmuneornot.com. (To date, this popular Connective Tissue Disease Screening Questionnaire (CSQ) has had over 206,000 users.) Visitors to the site who were screened and showed possible or probable signs of lupus were offered participation in the PROACTIVE^™ study. Once enrolled, the participants progressed through a comprehensive virtual diagnostic journey including:

• Telehealth consultations with primary care physicians and rheumatology specialists
• At-home mobile phlebotomy services for lupus-associated biomarker testing
• Expert rheumatologist review of medical records and laboratory results
• Final SLE classification based on established ACR 1997 and EULAR/ACR 2019 criteria

Of the participants completing the study, 18% were classified as having SLE, 46% as incomplete SLE, and 36% as not showing any indication of SLE. These results demonstrate the potential for digital health tools and biomarker integration to provide earlier clarity for individuals navigating the often-complex lupus diagnostic journey.

"This time taken to classify these participants was in a study setting and will be accelerated when applied to individual patients," said Dr. Eldon Jupe, PhD, Chief Research & Laboratory Officer and Principal Investigator of the study. "The ability to inform their primary care physician that they have been potentially classified as a lupus patient is a major accomplishment."

This study, funded in part by GSK, reinforces Progentec's ongoing commitment to bringing patient-centered, technology-driven solutions to market. The findings will inform future research and product development aimed at making lupus classification faster, more accurate, and more accessible.

For more information about Progentec's lupus diagnostics and digital health innovations, visit www.progentec.com.

About Progentec Diagnostics, Inc.

Progentec Diagnostics is dedicated to improving health outcomes for individuals with autoimmune diseases through clinically validated biomarker testing (aiSLE^® DX Flare Risk Index and aiSLE® DX Disease Activity Index for Lupus) and digital health technologies (CareMGMT ^™ app). Partnering with researchers, healthcare providers, and patient communities, Progentec works to close diagnostic gaps and bring precision medicine to the forefront of autoimmune care.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company.

Contact:

Heather Iyer

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SOURCE Progentec Diagnostics, Inc.