Progentec Readies Launch of Digital Lupus Research Study

- Participants use LupusCorner® Research, a 21 CFR Part 11-compliant app developed by Progentec

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Apr 21, 2020, 12:32 ET

OKLAHOMA CITY, April 21, 2020 /PRNewswire/ -- Progentec, a leader in next-gen diagnostics and digital technologies for the management of autoimmune diseases, is announcing the launch of the OASIS Study. The purpose of the study is to measure and validate the link between digital signals and systemic lupus erythematosus (SLE).

"OASIS is a 100% remote clinical research study. Participants can sign up online and complete the study without ever visiting a clinician," said Eldon Jupe, Ph.D., the Principal Investigator for the study and the Chief Research Officer at Progentec.

This study will further Progentec's efforts to develop digital biomarkers for the prediction of lupus flares and the measurement of disease activity. These digital biomarkers complement the blood-based biomarkers used in Progentec's aiSLE^(™) DX laboratory tests, which will be available to rheumatologists and other healthcare professionals in 2020.

"Patient reported outcomes and sensor data from smart devices strengthen emerging models of remote patient care, including the use of telemedicine. These solutions empower clinicians by giving them the health data they need to make proactive treatment decisions. More than ever before, we are seeing the important role these technologies will play in improving care delivery and decreasing healthcare costs," said Mohan Purushothaman, Ph.D., CEO of Progentec.

OASIS study participants will use Progentec's LupusCorner^® Research app, a 21 CFR Part-11-compliant data capture tool built using the FDA's open source MyStudies codebase. The app is a powerful tool that allows Progentec to conduct clinical grade studies across multiple therapeutic areas with strong configuration capabilities. It is available on both iOS and Android platforms.

LupusCorner^® Research offers:

Informed eConsent;
Integration of wearable device data from Withings products including their smartwatch, "Steel HR";
Heart rate variability measurements using the device camera and flashlight; and
Scheduled, adaptive surveys

The OASIS study is expected to begin in May 2020 and will involve 550 participants.

The study enhances Progentec's digital capabilities to further partnerships with large research organizations and pharmaceutical companies working on lupus trials.

About Progentec Diagnostics, Inc.

Progentec is committed to improving access and health outcomes for patients in therapeutic areas with a high level of unmet need by combining clinically-validated diagnostic interventions with state-of-the-art digital technologies. Through collaborations with research institutions and health practitioners around the world, Progentec is working to reduce mortality and morbidity while improving care management and service delivery for chronic health conditions.

Forward-Looking Statements:

Statements contained herein that are not historical facts are forward-looking statements that represent management's beliefs and assumptions as of the date of this news release based on currently available information. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it cannot assure that these expectations will prove to be correct. Such statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in any forward-looking statements.

Contact:
Mohan Purushothaman
(973) 885-5242
[email protected]

SOURCE Progentec Diagnostics, Inc.