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Study Probes Lupus Digital Diagnostics

Woman with phone and laptop

(FirmBee, Pixabay)

21 Apr. 2020. A company creating diagnostics for autoimmune disorders is beginning a study next month to measure links between its blood-based and digital indicators for lupus. The study, conducted by Progentec Diagnostics Inc. in Oklahoma City, is being done with telemedicine, using the company’s smartphone apps.

Systemic lupus erythematosus — or SLE, the full name of the disorder — is an autoimmune disease, where the immune system is tricked into attacking healthy tissue and cells, in this case leading to inflammation in the joints, skin, and other organs including heart, lungs, and kidneys. The disorder is more common in women than men, mainly affecting individuals between the ages of 10 and 50, as well as people of African, Hispanic, and Asian heritage. Lupus Foundation of America estimates more than 1.5 million Americans have the disease, with 5 million worldwide.

Progentec Diagnostics designs tests for diagnosing and managing autoimmune diseases that measure protein biomarkers in blood, as well as capture reports by patients with their smartphones. The company is developing tests for lupus with its aiSLE DX blood-based biomarker technology that detects the disease in its early stages, measures disease activity, and predicts flares, a return or increased intensity of symptoms, scheduled for availability later this year.

Progentec also offers an online community and smartphone app for lupus patients called Lupus Corner, available as a free download from the App Store or Google Play. The app, says the company, provides tools for patients to track the progress of their disease, get information about lupus from experts, and take part in community forums with other lupus patients. Progentec says the Lupus Corner app is built using FDA’s MyStudies open-source code platform to meet federal security and auditing requirements.

In addition, the app makes it possible to capture data provided by patients for studies of lupus. The new study, called Oasis, aims to enroll 550 individuals with lupus, who will use the Lupus Corner app to record their experiences with the disease in weekly surveys of flares and symptoms. Some 200 participants will also be asked to record data on heart rate, sleep, and physical activity with a smartwatch supplied by the company.

“Oasis is a 100 percent remote clinical research study,” says Progentec research director and project leader Eldon Jupe in a company statement released through PR Newswire. “Participants can sign up online and complete the study without ever visiting a clinician.”

Results from the study, scheduled to begin in May, are expected to help Progentec refine its digital lupus indicators that the company says supplement its blood-based biomarkers. “Patient reported outcomes and sensor data from smart devices,” says Mohan Purushothaman, Progentec’s CEO, “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.”

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