The critical importance of sensitivity and how inivata’s technology is expanding the reach of liquid biopsy into new clinical and pharmaceutical applications.

Antony Newton, VP Business Development, talks about the critical importance of sensitivity and how Inivata’s technology is expanding the reach of liquid biopsy into new clinical and pharmaceutical applications.

Having joined Inivata recently, I have been working with the team on how our technology can be applied in areas that make a significant difference to cancer research, and in particular pharmaceutical development.  With a commercially available product in InVisionFirst-Lung, Inivata has a clinically proven assay providing a strong base for a biopharma partnering business and we are actively advancing aspects of the technology.

InVision’s sensitivity is well suited to MRD detection

One of the key metrics of a liquid biopsy is sensitivity. This is a function of ability of the assay to analyze small amounts of tumor DNA within a large pool of normal DNA and how well the technology can develop a strong measurable signal. Inivata’s InVision liquid biopsy platform is based on pioneering research from the Cancer Research UK Institute, University of Cambridge and uses a barcoded PCR amplicon approach. This very efficiently maintains DNA quantity through the preparation process (compared to traditional hybrid capture approaches) while the PCR element of the process allows for the amplification of small amounts of signal to be measured by high throughput DNA sequencing. Inivata has been looking at applications where this high sensitivity might provide a particular benefit and has focused on detecting the small amounts of DNA circulating in patients who have had surgery or undergone treatment but may have some of the disease remaining. This is often termed detection of Minimal Residual Disease or MRD.

Developing a standardized process to make personalized assays for MRD

Inivata is currently comparing and optimizing the best approaches for detection of MRD. One approach being optimized currently is analyzing the patient’s tumor tissue to identify a set of mutations that can be used to develop a personalized assay for each patient. It is important that the mutations selected are not likely to change upon treatment or the development of resistance in the tumor. A personalized assay of this type will allow a patient to be assessed soon after initial surgery, or during treatment, and could provide a dynamic measure of treatment effectiveness. Such approaches may allow much earlier identification of potential relapse and changes to treatment or options for new clinical trials.

Assisting with clinical trials

MRD assays can be used in the recruitment of patients for clinical trials. One setting for this would be to monitor patients after surgery, and then only recruit those patients who show early signs of recurrent disease by MRD assay. This population would provide an enriched group for testing of new therapies. The elimination of patients with no residual disease would spare them unnecessary treatment. Additional benefits of Inivata’s approach is a very fast turnaround time, so that patients and their physicians can receive results and learn of eligibility for trials within a few days.

Future directions

In addition to MRD detection, Inivata is using the power of high sensitivity to profile tumors where no tissue is available, which is often the case in lung cancer and certain other tumors. Another novel approach beyond this is to use a variant of the assay to profile for prediction of response to immunotherapies and to monitor early response. In the future, the company vision is that different variants of the assay powered by the Inivata technology platform can be used throughout the continuum of diagnosis, treatment and clinical trial. On a personal note, it is very exciting to be working with a group of motivated and dedicated scientists on both sides of the Atlantic, bringing important advances to the medical community.

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