Breast cancer (BCa) is a heterogeneous disease, a spectrum of subtypes with distinct biological features that lead to differences in treatment response and clinical outcomes. The diagnosis of BCa still suffers from imprecise diagnostics often relying on a single technology, and consequently failing to deliver accurate data for selecting the most effective treatment.
Diagnosis of BCa typically involves pathological examination of a patient specimen (e.g. biopsy, resected tumor) using histological and immunohistochemical analyses. Although this provides critical data about cellular morphology, the information is largely qualitative, and the number of biomarkers is minimal. On the other hand, multigene assays provide crucial quantitative data on numerous genes involved in cancer, but they lack insights into cellular morphology and the spatial relationships of gene expression. These limitations can lead to inadequate or inappropriate treatment causing significant burden to patients, families, and society.
Our main objectives are both technical and strategic. From the technical standpoint, we aim to improve assay performance and accuracy by optimizing protocols for tissue preparation, RNA-FISH and -sequencing, scale up the number of biomarkers from 8 to 25+, and automate aspects of the workflow. Strategically, we strive to complete a large-scale retrospective validation of Multiplex8+, engage with KOLs and other stakeholders to facilitate fundraising and validation projects (e.g. companion diagnostics), revamp our commercialization and branding strategy, and establish an ISO 15189-accredited lab to offer Multiplex8+ as a laboratory service.
