Foresight Diagnostics, a provider in cancer diagnostics and cancer relapse testing, announced that the U.S. Patent and Trademark Office (USPTO) granted the company patent No.11,447,833 for the detection of minimal residual disease (MRD) using its personalized phased variant detection platform.

“We are pleased that the USPTO has recognized the novel nature of our proprietary technology and are excited about the impact we believe this technology will have on the lives of cancer patients,” says Jake Chabon, PhD, CEO of Foresight Diagnostics. 

This granted patent covers Foresight’s PhasED-Seq technology and the workflow behind the Foresight Solid Tumor Recurrence Test, an assay used to detect minimum residual disease (MRD) from the plasma of cancer patients using DNA sequencing. The test is custom designed for each patient to track phased variants identified from tumor tissue samples using whole genome sequencing. The test enables improved sensitivity for MRD detection, providing a limit of detection below one part per million. 

“Ultra-sensitive MRD tests are essential to detect residual disease and recurrence following completion of curative intent therapies,” says Ash Alizadeh, MD, PhD, co-founder and chief medical advisor at Foresight. “PhasED-Seq has been used in more than 20 different clinical studies, and can predict cancer relapse when tumor burden is low and patients are more likely to favorably respond to anti-tumor therapy. Sensitivity for MRD detection is important for all types of cancer and is particularly critical for cancers that shed relatively small amounts of circulating tumor DNA (ctDNA) into the bloodstream such as lung and breast cancer.” 

PhasED-Seq lowers the error profile of mutation detection in sequencing data by requiring the concordant detection of two separate non-reference events in an individual DNA molecule. 

“Issuance of this patent by the USPTO is an important milestone in our quest to bring Foresight’s best-in-class MRD testing to cancer patients,” says Chabon. “The increased sensitivity of the PhasED-Seq MRD testing platform has the potential to dramatically improve patient outcomes, both in terms of identifying candidates for new therapeutic regimens as well as relieving patient anxiety around cancer relapse. We’ve seen significant commercial interest in our MRD testing platform from both academic and industry partners and are already planning discussions with the FDA to identify the most expedient regulatory pathway to bring this test to patients. We’re excited to see how oncologists and drug developers can use PhasED-Seq to enhance cancer care.”