Mologic’s infection test for dialysis patients bags CE mark

Mologic's test is designed to catch peritoneal infection early so patients can avoid further complications. (Lindstrom et al CC-BY 4.0)

U.K.-based Mologic has earned a CE mark for a point-of-care test that screens peritoneal dialysis patients for infection. The test, designed for at-home use, rapidly warns patients and caregivers of infection.

Unlike hemodialysis, which uses an external filter to clean the blood, peritoneal dialysis uses the peritoneum—the membrane that lines the inside of the abdomen—as a natural filter. Hemodialysis may be performed at a dialysis center, hospital or at home, but it requires patients to be connected to a dialysis machine for hours at a time, multiple times a week. Patients on peritoneal dialysis may be treated while they go about their daily activities, or at night, while they sleep.

Both types of dialysis require an access point. Peritoneal dialysis patients will have a catheter surgically placed in the chest or abdomen ahead of treatment. Patients with catheters in their abdomen are more prone to peritonitis, a serious infection that requires antibiotic treatment. Quick treatment is crucial in warding off further problems, including damage to the peritoneal membrane.

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

RELATED: Physician payment reform has made home dialysis less popular: Study

Current tests can take longer than 24 hours to diagnose infection, while Mologic’s Periplex test returns results in 10 minutes, the company said in a statement. It detects two infection biomarkers in waste fluid from peritoneal dialysis. If given a positive result, a patient may then promptly seek care.

The company also announced the test's commercial launch in the statement.

“PERiPLEX is the first of a pipeline of products from Mologic to receive CE mark approval. We are developing similar diagnostic tests for a range of disease areas, including sepsis, urinary tract infections and chronic obstructive pulmonary disease (COPD),” said CEO Mark Davis in the statement. “Each of these tests use lateral flow immunoassay technology to detect a host inflammatory response, for rapid, point-of-care diagnosis and, importantly, to enable earlier treatment for patients.”