BEYOND STATE OF THE ART
Large numbers of protein biomarkers are currently measured clinically in tissue sections by single-plex immunohistochemistry using multiple separate slides. Pathologists’ have to visually inspect the tissue sections to analyse the pattern of cells, which is time consuming and limited by the capabilities of the human eye to the use of 2 or perhaps 3 biomarkers.
There are currently two automated methods capable of measuring multiple biomarkers, but not the pattern, in a single section. These competing systems generate x,y coordinate data for cells positive for one or more biomarkers and have software for counting the number of cells positive for each biomarker. These systems stain the tissue sections with incumbent molecular fluorophore-biomarker conjugates that require sequential deposition, washing and separate visualisation using multiple light sources and are prone to photobleaching within a couple of minutes when irradiated. Neither system can analyse the pattern of cells and there is evidence that the order of staining the tissue sections influences the resulting images.
Chromition’s approach involves the use of exceptionally bright and stable Luminsphere™-antibody conjugates, that enables the single staining, single washing and simultaneous visualisation of multiple biomarkers and automated analysis. Significant commercial innovation emerges from combining Luminspheres™ technology with automated multispectral pattern analysis.
IMPACTS
The technology will transform the way clinical pathology is practised, by enabling high-throughput automated objective pattern analysis of the 100 million immunohistochemistry tissue sections globally each year. This in turn facilitates faster and more effective prognosis and diagnosis, better outcomes for patients, reduced treatment costs and improved treatment outcomes for patients. Being able to identify clinically useful patterns will improve the patient pathway by allowing patient selection for immunotherapy, avoiding unnecessary morbidity in likely non-responders. This will allow resources to be efficiently directed toward effective patient care.
The platform will be a key facilitator for the adoption of precision medicine within oncology. Also, it is less invasive to the patient requiring only a single tissue section; offers the patient earlier, more efficient and effective diagnosis of cancer; more detailed picture of disease status and progression; enables proactive management of health conditions through personalised treatment selection and improved treatment outcomes for patients.
