MicroBioSensor currently has three products in development based on its underlying MicroBioSensor™ technology.
Our lead product, QuickCheck, is an early warning system for life-threatening peritonitis. The QuickCheck device enables medical staff to be alerted if high leukocyte or microbial cell levels are indicated by a colour change in any of three windows. These results are available immediately at the end of an overnight dialysis session.
QuickCheck also provides sensitivity data for vancomycin, the front line antibiotic most most commonly prescribed for infective peritonitis. It is therefore able to flag an emerging infection at an early stage and confirm infective peritonitis without further delay: something no other product on the market can do. It also provides guidance on the correct choice of antibiotic to treat the infection.
The QuickCheck device will begin final clinical assessment in Q1-Q2 2020, ahead of self-certified CE Marking in July 2020. Additionally, a fully functioning companion TCU has been developed suitable for limited use by trained staff in hospitals, and which will also be CE Marked in July 2020.
A version of QuickCheck for use at home will enter clinical assessment for self-use by patients in Q3 2020, ahead of CE Marking (via our Notified Body) for approval in Q3 2021. This device will be adapted for higher volume use in patients’ homes, by making it smaller, simpler and quieter.
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 Q1 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 is scheduled for 2020, and the product will enter full clinical assessment in 2021.