Exclusive arrangement will expand market access to Personalis’ ultra-sensitive MRD test
Personalis, Inc., a leader in advanced genomics for precision oncology (Nasdaq: PSNL), and Tempus Labs, Inc., a leader in artificial intelligence and precision medicine, today 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,” said 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.”
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
- 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,” said Eric Lefkofsky, Founder and CEO of Tempus.
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect MRD and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.
Personalis Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to potential testing volume, the attributes, advantages or clinical validity of the NeXT Personal Dx test, or the expected benefits of Personalis’ collaboration with Tempus. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity of the NeXT Personal Dx test, Personalis’ achievement of milestones set forth in the collaboration and co-commercialization agreement with Tempus, the success of Tempus’ sales and marketing efforts, and the adoption and use of the NeXT Personal Dx test by oncologists. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (SEC) on February 23, 2023, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 7, 2023. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.