Personalis, a developer in advanced genomics for precision oncology, and Tempus Labs, a provider in artificial intelligence and precision medicine, announced a strategic collaboration to co-commercialize NeXT Personal Dx, Personalis’ whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer.

NeXT Personal Dx is a leap forward in tumor-informed approaches, setting the new standard in performance of MRD tests with unprecedented sensitivity and high specificity. The test was launched by Personalis in October of this year.

The two companies will work together exclusively in tumor-informed MRD testing for lung cancer, as well as breast cancer and immunotherapy monitoring after clinical validation of NeXT Personal Dx in those indications. The agreement contemplates testing up to tens of thousands of new patients over the next three years. 

“A core part of our ‘Win in MRD’ strategy has been to partner with a top oncology testing company with a leading sales channel to co-commercialize NeXT Personal Dx,” says Chris Hall, president and CEO of Personalis. “With today’s announcement, we have fulfilled that part of our strategy and we are excited about starting the journey together with Tempus to bring our NeXT Personal Dx test to the country’s oncologists and their patients.”

Further reading: Personalis’ MRD Assay Detects ctDNA in Lung Cancer Patients Earlier

As a part of the deal, Tempus will:

  • Provide up to $12 million to Personalis as certain milestones are met, to help fund clinical evidence development for NeXT Personal Dx
  • Integrate NeXT Personal Dx into its testing menu
  • Provide access to oncologists through its sales and marketing efforts

Personalis will:

  • Compensate Tempus for the fair market value of sales, marketing, order requisition, and results delivery services
  • Receive, process, and bill NeXT Personal Dx tests that are ordered, while driving reimbursement
  • Complete clinical validation work for breast cancer and immunotherapy monitoring indications
  • Provide warrants to Tempus to purchase up to approximately 9.2 million shares of Personalis’ common stock over the next 24 months

“We believe that monitoring cancer recurrence is an important emerging development that has the potential to transform the way cancer is managed and Tempus is excited to bring this best-in-class tumor-informed test to oncologists to complement our existing tumor naïve MRD strategy,” says Eric Lefkofsky, founder and CEO of Tempus.