Hematology test developer PixCell announced on Thursday the results of a clinical evaluation by researchers at the South London and Maudsley NHS Foundation Trust, a U.K. mental health hospital and research institution, demonstrating that PixCell’s HemoScreen is suitable for complete blood count (CBC) analysis in point-of-care settings.
HemoScreen, which is FDA-cleared and CE-marked, is a portable platform that offers readings of 20 standard blood count parameters within five minutes utilizing one finger-prick of blood.
The use of finger-pricking for accurate sampling was especially important in the study: the cohort of 226 patients were being treated with clozapine for the management of schizophrenia. Therapeutics such as clozapine have serious side effects that necessitate regular blood counts, and the current protocol for CBC testing for clozapine thus requires weekly blood draws. The psychiatric patient population has a high rate of needle anxiety; the requirement of weekly blood draws has a significant negative effect on clozapine treatment enrollment and adherence.
For this reason, the South London and Maudsley NHS Foundation Trust was performing the evaluation program to find a point-of-care CBC analyzer which was comparable to central lab-based analysis in diagnostic quality, was easy for medical staff in clozapine clinics to administer, and allowed finger-prick sampling.
The study, which is being published in the Journal of Psychiatric Research, concluded that HemoScreen is a suitable finger-prick diagnostic for this patient population, with the potential to substantially enhance treatment enrollment and adherence.
“HemoScreen offers a portable, quick, and accurate alternative to the current venous blood non-portable methods of clozapine monitoring, and from a single drop of either capillary or venous blood,” the researchers stated in their article. “This device is therefore suitable for all clinical settings associated with clozapine treatment; clinics, wards, and community-based services, and with a simple blood sample collection method, improves upon a previously evaluated non-portable device.”