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Personalis Expects Accelerated Clinical Growth Under Tempus Marketing Deal


NEW YORK – Sequencing firm Personalis last week continued its pivot from primarily a biopharma and population sequencing business to a clinical cancer testing company, inking a commercialization partnership for its minimal residual disease (MRD) test with Tempus and laying off 20 percent of its workforce.

The firm took its first steps in this direction in October with the early-access launch of NeXT Personal Dx, a patient-personalized MRD assay system informed by whole-genome sequencing of tumor tissue.

The launch came just a few days after investigators from the TRACERx study presented updated data showing that NeXT Personal could detect pre-treatment ctDNA in significantly more lung cancer patients than technologies used previously in the cohort now jockeying for commercial dominance.

Personalis CEO Chris Hall said this week that the company could have built a commercial team on its own, but the Tempus partnership has significant advantages.

"I spent my life building sales and marketing forces to commercialize these products, and there's nothing in this agreement that says that we can't continue to build any sort of group that we want to build on our own, but [this deal] allows us to do a couple of things. First of all, it validates what we are doing with a major player. That's really important," Hall said.

"Secondly, it provides access to a few hundred reps on the ground out of the gate," he added. "To build that infrastructure and to get that up and running takes time and money and capital and effort, so this allows us to move that much faster."

As an established clinical testing firm, Tempus also has a logistical advantage with EMR integration and robust systems for sample collection and requisition. "When you're doing that as a startup, you've got to start from square one doing that in every single sales situation you're in, [but] they already know that world and they've already walked through that journey … so, doing that with a partner, I think, is a great way to get these products off the ground," said Hall.

Not having to build out a larger marketing force right away means that Personalis can keep its own focus on building evidence for Medicare reimbursement, which it is already doing for its initial lung cancer indication, as well as additional use cases in early breast cancer and in immunotherapy response monitoring.

"We'll start in a smallish way, but when we get Medicare reimbursement, we'll be able to hit the gas very fast," Hall said.

Not having to build out its own sales force and test requisition infrastructure is especially valuable in light of the workforce cuts that the firm has made this year, initially laying off about 100 individuals in January, and continuing last week with an approval to let go an additional 65.

Hall described the layoffs as part of the company's shift toward becoming a "commercial engine" — necessary to ensure enough cash to see Personalis through the sometimes-lengthy process of getting Medicare reimbursement. "We have the cash now to get into 2026, so that gives us plenty of time," he said.

The workforce reduction has also been about efficiency, he added, again reflecting Personalis' commercial pivot. "We found a lot of ways to consolidate groups … reigning in a larger organization and slimming down into something that was much more streamlined and efficient," Hall said.

The company had been considering potential partnerships from the beginning of Hall's tenure as CEO, and he said that Tempus was an obvious choice as a precision oncology pioneer with dedication to the type of comprehensive approaches that have been Personalis' hallmark.

For Tempus, the partnership gives it a piece of the MRD market, the attractiveness of which is evidenced by the swath of intellectual property litigation that has spread in recent years.

The companies' deal doesn't involve any technology licensing, so it would be unaffected by the outcome of Personalis' own ongoing lawsuit against MRD startup Foresight Diagnostics.

Over the next year, Hall said Personalis will be focusing in-house on evidence development, including academic collaborations in breast cancer, ongoing analysis from the TRACERx lung cancer study, and immunotherapy monitoring cohorts being analyzed.

The company believes it should be able to cement Medicare coverage for one of these indications by the end of 2024, with the others following later.