Tempus - Lab

Precision oncology genomic testing company Personalis announced Tuesday that it is partnering with AI-driven precision medicine company Tempus to co-commercialize its molecular residual disease (MRD) test in lung and breast cancer. The test, NeXT Personal Dx is Personalis’  tumor informed whole-genome liquid biopsy laboratory developed test (LDT) the company launched a month ago to address the growing MRD and cancer recurrence testing market.

“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.”

The two companies anticipate they will test up to tens of thousands of patients with the test over the next three years for lung cancer patients, as well as breast cancer, and immunotherapy once clinical validation has been completed for those indications.

Under the terms of the deal, Tempus will provide up to $12 million to Personalis based on meeting certain milestones; will integrate NeXT Personal Dx into its current testing menu; and will provide access to the test to oncologists via its sales and marketing channel. Personalis will compensate Tempus for the fair market value of sales, marketing, order requisition and results delivery; process and bill for the tests that are ordered while working to secure reimbursement from payers; and complete validation for breast cancer testing and immunotherapy indications.

In addition, Personalis will provide warrant to Tempus for the potential purchase of up to 9.2 million shares of Personalis’ common stock over the next two years.

Commenting on the deal with Personalis, Eric Lefkofsky, CEO of Tempus noted that the company see the monitoring of cancer recurrence as an “important” emerging area within cancer testing that has the potential to significantly change how cancer patients are treated and managed. The NeXT Personal Dx becomes the first tumor-informed MRD and cancer recurrence test offered by Tempus, which Lefkofsky noted will “complement our existing tumor naïve MRD strategy.”

Personalis launched an early access program for NeXT Personal Dx on October 26. Features of the test include:

  • Analytical sensitivity that can detect down to ~1 PPM (parts per million) or 1×10-6 tumor fraction and >99.9% analytical specificity
  • Using a tumor-informed approach the test selects up to 1,800 variants to design a highly sensitive and specific personalized tumor signature for each patient
  • Employs the company’s proprietary NeXT SENSE technology for signal enhancement and noise suppression that, when combined with together with the personalized tumor signature, provides ultra-sensitive detection.

At the time of the launch, Personalis also released results at the European Society for Medical Oncology (ESMO) Congress of the TRACERx study that investigated the use of NeXT Personal Dx in early-stage lung cancer for MRD and recurrence detection. The company, and its collaborators in the TRACERDx study Cancer Research U.K.’s Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute, presented data that showed the test could identify cancer recurrence between six to 11 months earlier than traditional imaging technology currently used.

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