Mologic Receives CE Mark Approval for PERiPLEX Diagnostic

Mologic has announced it has received CE mark approval for PERiPLEX®, a rapid point-of-care test for the detection of infection in patients on Peritoneal Dialysis (PD). The Company also announced the commercial launch of the test, which has been developed to be used at home by patients or their carers to enable warning of infection within 10 minutes. 

There are over 200,000 patients being treated with PD globally, and it is widely accepted as the preferred method for managing severe chronic kidney disease (CKD) or end stage renal disease (ESRD). It is a type of dialysis that uses the peritoneum in a patient's abdomen as the membrane through which fluid and dissolved substances are exchanged with the blood. It is used to remove toxins and excess fluid, and correct electrolyte problems in those with kidney failure. However, PD is known to have a high rate of associated infections, which can lead to peritonitis. 

Using current methods, diagnosis of infection can take more than 24 hours, which risks damage to the peritoneal membrane, or the formation of scar tissue can prevent the long-term use of PD. PERiPLEX detects two critical biomarkers of infection in PD waste fluid using a lateral flow immunoassay system, and provides results within 10 minutes. A positive result can give PD patients warning of an infection, prompting them to contact their healthcare provider to initiate antibiotic therapy. Earlier identification of infection would enable pre-emptive use of available antibiotics, resulting in improved management of infection and prevention of infection-related damage to the peritoneal membrane.

Mark Davis, co-founder and CEO at Mologic commented: “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). 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.