Foresight Diagnostics Official Response to Meritless Lawsuit Filed by Roche

On October 2, 2024, Foresight Diagnostics founders Dr. Maximilian Diehn, Dr. Arash Ash Alizadeh, and Dr. David Kurtz filed answers in the U.S. District Court for the Northern District of California to the lawsuits filed by Roche Molecular Systems (RMS) and Roche Sequencing Systems (RSS) against Stanford University, three Stanford oncologists who are Foresight Diagnostics co-founders, and Foresight Diagnostics.  

We believe that the lawsuits are a meritless and ultimately futile attempt to disrupt market adoption of the Foresight CLARITY™ minimal residual disease (MRD) offering, which has the potential to help patients fight cancer worldwide. Unfortunately, misguided litigation such as this stifles innovation. We remain confident in our ultra-sensitive MRD technologies and look forward to our continued partnership with leading researchers and customers to enable clinically-actionable decisions at the moments that matter most in the patient journey.  

As outlined in the full filing by Foresight’s founders, Roche’s allegations fail for many reasons, including the following: 

  • Roche’s claim that PhasED-Seq™ is based on CAPP-Seq trade secrets ignores the fundamental differences between CAPP-Seq and PhasED-Seq™.
  • Roche’s alleged trade secrets were neither secret nor owned by Roche. Stanford is the owner of the CAPP-Seq know-how which Roche points to as its own trade secrets, and Stanford publicly disclosed this know-how years ago, in the form of publicly available patent fillings and scientific publications.
  • Stanford properly owns the PhasED-Seq™ technology at issue and Foresight is the exclusive licensee.
  • Roche has known for many years that Foresight, through Stanford, has had exclusive rights to PhasED-Seq™. All of Roche’s claims fail since the statute of limitations has elapsed.

In 2011, Drs. Diehn and Alizadeh developed the CAPP-Seq cancer diagnostic technology. CAPP-Seq is a multi-purpose circulating tumor DNA (ctDNA) assay that was highly sensitive for its time and is capable of identifying cancer-related single nucleotide variants, insertions/deletions, genetic fusions, and copy number variants. In April 2015, Roche acquired Capp Medical, a startup that Drs. Diehn and Alizadeh co-founded to commercialize the CAPP-Seq technology. 

Years later and as part of their academic research at Stanford, Drs. Diehn and Alizadeh, together with their colleague and former graduate student, Dr. Kurtz, invented a new and different technology called PhasED-Seq™ that tracks a different class of cancer-specific mutations called phased variants and is over 100 times more sensitive than CAPP-Seq. Roche is now suing Stanford University, Drs. Diehn, Alizadeh and Kurtz, and Foresight Diagnostics in connection with the Stanford patents licensed to Foresight, alleging trade secret theft and other unsupported allegations.

Below is a previously-issued company statement following Roche’s filing of the lawsuit in July 2024:

Boulder, CO, July 3, 2024 – Foresight Diagnostics, Inc. (Foresight) a leading diagnostics company specializing in the development of ultra-sensitive minimal residual disease (MRD) detection, today shared the following statement regarding the lawsuits filed by Roche Molecular Systems (RMS) and Roche Sequencing Systems (RSS) against Stanford University, three renowned Stanford oncologists who are Foresight founders, and the company regarding Stanford patents licensed exclusively to Foresight. 

We believe that these claims are meritless. Stanford University (Stanford) owns the patents in dispute, and Foresight’s founders created the industry-leading technology at issue using Stanford time and resources, under agreements with Stanford. Indeed, Roche has known that Foresight, through Stanford, has had exclusive rights to this intellectual property for many years. RMS acquired prior, different technology in 2015 known as CAPP-Seq. Now, recognizing the strength of Foresight’s new and independently developed PhasED-Seq™ technology, Roche has brought litigation as a negotiating tactic to try and force a result to which it is not entitled.

Dr. Jake Chabon, PhD, Foresight’s CEO and co-founder, said, “Dr. Diehn, Dr. Alizadeh and Dr. Kurtz are distinguished leaders in oncology. We are confident that they abided by the terms of their agreements with both Stanford and with Roche and that Roche has no trade secrets in intellectual property owned by Stanford. Foresight intends to vigorously defend this litigation and demonstrate that Roche’s allegations are baseless. Foresight is committed to developing innovative solutions proprietary to Foresight that are intended to improve the lives for cancer patients worldwide. We will continue advancing our ultra-sensitive MRD technologies and partnering with leading researchers and customers to move the field forward for the patients who are waiting for us to succeed.”

Media inquiries may be directed to foresight@argotpartners.com.