MicroBioSensor currently has three products in development based on its underlying MicroBioSensor™ technology.
Our lead product, QuickCheck, is a point of care diagnostic for patients on peritoneal dialysis therapy. QuickCheck enables medical staff to instantly measure white blood cell levels in a patient’s dialysis effluent. For most patients, most of the time, QuickCheck will simply reassure that all is well and that their white blood cell (leukocyte) levels are within normal bounds.
But if a patient is in the early stages of a potentially life-threatening peritonitis episode, their leukocyte levels will be raised significantly and QuickCheck will confirm this before any such changes are visible by eye. By flagging an emerging infection at an earlier stage than is currently possible, QuickCheck will allow healthcare professionals to make an informed decision on appropriate actions in a more timely manner, helping prevent serious complications and keeping more patients on their preferred therapy for longer.
The QuickCheck device is currently undergoing clinical assessment and a self-certified CE Mark filing is planned in late 2021.
A version of QuickCheck for use at home will enter clinical assessment for self-use by patients in 2022, ahead of CE Marking (via our Notified Body) for approval in 2023.
The STAR system has been developed to test urine samples from UTI patients for antibiotic resistance against five commonly used antibiotics.
A key component is the development of an optical reader for assessing the output of the device, which enables a readout within five hours, and appreciably reduces the size of the companion instrument. The STAR cassette has been designed to provide an automatic diluting function, to enable the device to be used by untrained workers in a care home pharmacy or GP clinic setting.
The cassette and optical reader designs are being finalised and tested by our design and prototyping partners Smallfry (Coventry), and Datalink Electronics (Loughborough).
A clinical assessment is underway to finalise the sample processing protocol ahead of a CE Mark clinical study scheduled for 2021.
PERIFAST: Peritoneal Fluid Antimicrobial Sensitivity Test
PERIFAST is a powerful in-clinic product, providing rapid antimicrobial sensitivity testing for patients arriving at hospital with peritonitis (either PD peritonitis or SBP). PERIFAST will be positioned alongside QuickCheck as an essential test for all patients arriving at clinic with suspected peritonitis.
The system is based around the STAR optical reader and cassette which will be adapted for use with a higher number of antibiotics. This R&D programme is ongoing, and the product will enter full clinical assessment in 2022.