Monitoring Response to Systemic Therapy in Non-Small-Cell Lung Cancer (RUO)

Measuring cfDNA in plasma of patients undergoing anti-cancer treatment with checkpoint inhibitors, targeted treatments, chemotherapies, and combination regimens.

 A working prototype of the OmniVerita™ system.

A working prototype of the OmniVerita™ system.

OmniVerita™ system (RUO) is is the first clinical application of the Verita™ platform that is currently being developed by Biological Dynamics. 

This system consists of a disposable microfluidic cartridge, a fully automated benchtop analyzer (OmniVerita™, pictured on the left), and a growing portfolio of treatment response monitoring OncoState™ assays.

The system uses a small sample size (< 0.2 mL) and the results are available in less than 1 hour. Each cartridge incorporates 8 independent arrays and can accommodate up to eight samples per run. The analyzer applies thermal, fluidic, optical, and electrical effects, as well as software to isolate, detect and quantify cfDNA.

OncoState™ IO assay

The OncoState™ IO assay (RUO) measures concentration of cell-free DNA >300bp (cfDNA) in plasma of patients with advanced Non-Small Cell Lung Cancer (NSCLC) who are undergoing treatments with latest immuno-oncology regimens (See Fig. 1 below).  

 
 Figure 1. Timeline of a patient with stage IV Non-Small Cell Lung Cancer. The red portions indicate elevation in plasma cfDNA levels (as measured by OncoState™IO) and correlate with lack of treatment response.

Figure 1. Timeline of a patient with stage IV Non-Small Cell Lung Cancer. The red portions indicate elevation in plasma cfDNA levels (as measured by OncoState™IO) and correlate with lack of treatment response.

According to American Cancer Society, lung cancer is the leading cause of cancer death among both men and women worldwide. In 2018, an estimated 234,030 new cases of lung cancer will be diagnosed in the the United States. Non-Small Cell Lung Cancer (NSCLC) comprises 85% of all lung cancers.

The introduction of immunotherapy in 2015 marked a critical paradigm shift in the treatment of lung cancer. Immune checkpoint inhibitors, pembrolizumab (Keytruda), nivolumab (Opdivo), and atezolizumab (Tecentriq) continue to offer new hope to the vast majority of NSCLC patients (>80% in the Western world) who do not respond to standard chemotherapy or whose tumors do not have targetable mutations.

 

Why hmw cfDNA is important

The assay isolates and quantifies cell-free dsDNA directly from plasma of lung cancer patients undergoing systemic therapies. Studies have suggested that the change in concentration of the serially measured dsDNA correlates with treatment response in cancers.