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Lymphocyte numbers are crucial in health and disease but enumeration is rarely applied in molecular pathology. By combining digital PCR technology with rearrangement of T cell receptor and B cell receptor sequences, D4BST provides absolute lymphocyte quantification in minute amounts of DNA. Elementary handling and automated reporting facilitates high throughput analysis. The approach of D4BST is new and innovative and has been succesfully patented.

Non-Small Cell Lung Cancer (NSCLC), with an incidence of 800.000 new cases each year, is the second most common cancer and a leading cause of cancer mortality worldwide. Immune checkpoint inhibitors (ICI) have caused a revolution in the treatment of lung cancer as well as many other cancer types, that were difficult or even impossible to treat. ICI therapy is aimed at the PD-L1 feedback loop and enables the patient’s own immune system to “attack” the tumor. Hence, inhibition of the PD-L1 feedback loop without the presence of T cells and B cells turns out ineffective whereas tertiary lymphocyte structures that are correlated with accumulation of T- and B cells correlate with a good response. D4BST assesses the immune status by quantifying B cells, Switched B cells and T cells that jointly materialise the immune response. Fulfilling the need for immunophenotyping in a wide range of cancer samples, D4BST accurately differentiates responders from non-responders before treatment starts. This will reduce costs of ineffective treatment and release patients from preventable side effects. Moreover, effective therapy is beneficial for the society at large and contributes to sustainable pharma.

Currently we are running validation experiments as academic partner of the Pulmonology department but after clinical validation, co-development of D4BST by D4Diagnostics and pharma as biomarker in lung cancer is most likely as contacts with pharma (Genentech, Roche) have already bared interest in both the IP and the biomarker.