8-K: Personalis Expands NeXT Personal Market to Colorectal Cancer Through Extended Tempus AI Partnership

Personalis, Inc. announced an amendment to its agreement with Tempus AI, extending their partnership through 2029 and adding colorectal cancer as a new indication for its NeXT Personal minimal residual disease test, alongside an extended exclusivity period.

Summary

• Personalis, Inc. and Tempus AI, Inc. entered into Amendment No. 4 to their Commercialization and Reference Laboratory Agreement on July 8, 2025.
• The amendment authorizes Tempus to market Personalis's ultra-sensitive tumor-informed minimal residual disease test, NeXT Personal, for colorectal cancer.
• Colorectal cancer is the fourth indication for NeXT Personal under the Tempus Agreement, joining breast cancer, lung cancer, and immuno-oncology monitoring.
• The term of the Tempus Agreement has been extended through November 25, 2029.
• Colorectal cancer has been included as an indication subject to exclusivity in the Tempus Agreement.
• The exclusivity period, during which Personalis will not allow third parties to market NeXT Personal in the Indications and Tempus will not market competing assays, has been extended to December 31, 2028.
• Certain customary standstill restrictions agreed to by Tempus were modified to expire earlier of June 4, 2027, or the expiration/termination of the Exclusivity Period.

Sentiment

Score: 8

Explanation: The document details a significant positive development for Personalis, including the expansion of its flagship product into a new, large indication and the extension of a key commercial partnership with exclusivity, indicating strong future revenue potential and market positioning.

Positives

• Expansion of NeXT Personal's market reach into the significant colorectal cancer indication.
• Extension of the Commercialization and Reference Laboratory Agreement with Tempus AI through November 25, 2029, indicating a strengthened long-term partnership.
• Extension of the exclusivity period for NeXT Personal across all indications (breast, lung, immuno-oncology, and colorectal cancer) until December 31, 2028, providing a competitive advantage.

Future Outlook

The extension of the agreement term and exclusivity period, coupled with the expansion into colorectal cancer, indicates a strong commitment to the NeXT Personal platform and a long-term strategic partnership with Tempus AI, aiming for broader market penetration and sustained revenue generation from the test.

Management Comments

• The report was signed by Aaron Tachibana, Chief Financial Officer and Chief Operating Officer of Personalis, Inc.

Industry Context

The expansion of NeXT Personal into colorectal cancer aligns with the growing trend in precision oncology and the increasing adoption of minimal residual disease (MRD) testing for recurrence monitoring and treatment optimization. Partnerships like this between diagnostic developers and large commercialization entities such as Tempus AI are crucial for accelerating market access and leveraging established sales channels in the highly competitive oncology diagnostics landscape. Colorectal cancer represents a significant market opportunity for MRD testing.

Stakeholder Impact

• Shareholders: Potential for increased revenue and market share due to expanded indications and extended partnership, which could positively impact stock value.
• Customers (Oncologists, Patients): Access to NeXT Personal for colorectal cancer monitoring, potentially improving patient management and outcomes.
• Employees: Continued stability and potential growth opportunities within the company due to strengthened product commercialization.

Next Steps

• Tempus AI will commence marketing NeXT Personal for colorectal cancer.
• Personalis and Tempus AI will continue to operate under the extended terms of the Commercialization and Reference Laboratory Agreement until November 25, 2029.

Key Dates

Recommendation

Keywords

Personalis, Tempus AI, NeXT Personal, minimal residual disease, MRD, colorectal cancer, breast cancer, lung cancer, immuno-oncology, commercialization agreement, exclusivity, oncology diagnostics, genomic testing