Myriad Genetics, Inc.: Myriad Genetics Launches Prolaris + AI, the First Prostate Cancer Test to Combine Genomics and Digital Pathology Artificial Intelligence (AI)

SALT LAKE CITY, May 26, 2026 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, announces the launch of the Prolaris + AI Test at the end of this month. Prolaris will be the first and only prostate cancer biomarker test to unite clinical-pathological features, an independent molecular score, and independent AI-powered digital pathology technology.^1-4 This combination helps identify if a patient is safe for active surveillance (AS) and how refinement of AS intensity can be personalized.^4-8 This new paradigm in patient care builds upon technology from PATHOMIQ AI, a digital pathology AI platform company. The Prolaris + AI test is the only test where AS metrics on patient results were built on studies with previously diagnosed, untreated patient cohorts.^1-4 The Prolaris + AI test will continue to help doctors identify patients who are safe for single-modal treatment.^9-10

AS is recommended by major clinical guidelines for men with low- and favorable intermediate-risk prostate cancer, but follow-up can vary widely by the limited ability of traditional clinical and pathology tools to predict short-term tumor behavior to help guide surveillance intensity. The Prolaris + AI Test was developed to address this gap by providing the likelihood of a higher Gleason score at next biopsy to help clinicians tailor AS protocols.

"Prostate cancer is projected to be the leading cancer diagnosis in the U.S. this year, with more than 300,000 patients newly diagnosed. The Prolaris + AI Test introduces a valuable tool to use for active surveillance planning. The combination of Prolaris with AI marks meaningful progress in prostate cancer management for both patients and providers," said Brian Donnelly, Chief Commercial Officer, Myriad Genetics.

A New Approach to Integrated Prostate Prognostics

The Prolaris Biopsy Test has already outperformed other biomarker tests in identifying appropriate patients for active surveillance in low and intermediate-risk populations.¹¹ Without requiring additional tissue, the enhanced Prolaris + AI Test provides a single, integrated report that combines long-term prognostic risks from the Prolaris clinical cell-cycle risk (CCR) score and near-term likelihood of a higher Gleason score at the next biopsy, based on a PATHOMIQ AI-derived score. Together, these complementary insights help clinicians confirm active surveillance suitability and personalize surveillance intensity with greater confidence.

New Data Demonstrates a Role For AI in Prostate Cancer Risk Assessment

Prostate cancer is biologically diverse, even within the same tumor. AI-powered digital pathology detects morphometric patterns indicative of cancer aggressiveness in biopsy tissue that is not possible with traditional pathology.

In a recent validation study, an AI model was trained and developed on the prostate biopsy histopathology digital image features of 998 patients and validated in a cohort of 296 patients.⁴ All patients were candidates for AS by both guidelines and Prolaris criteria with diagnostic Gleason scores of 3+3 and 3+4. The validation study demonstrated that the AI-GUR (Artificial Intelligence-Gleason Upgrade Risk) is a statistically significant predictor of Gleason upgrade at first follow-up biopsy, independent of time elapsed since diagnosis and other clinical variables. Notably, AI-GUR provides information not captured by conventional risk stratification tools or cribriform morphology, underscoring its unique value. The predictive power of AI-GUR is robust across biopsy intervals, suggesting it may capture both disease progression and mischaracterization of the initial biopsy.

To learn more about this study, visit the preprint available here.

The new AI metric will be available for all Prolaris Biopsy Tests performed on samples in the U.S. (other than from New York State) starting with tests processed on May 29, 2026. Approval for samples from New York State is expected to come soon.

About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic and precision medicine company committed to advancing health and well-being for all. Myriad Genetics develops and commercializes molecular tests that help patients and providers uncover genetic insights. Our tests assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care, support earlier detection, enable more precise treatment and contribute to lowering healthcare costs. For more information, visit www.myriad.com.

About PATHOMIQ
PATHOMIQ's AI technology extracts hidden insights from complex cancer pathology to support faster and more accurate clinical decisions. By analyzing digital biopsy or surgical specimen images, it predicts patient outcomes and treatment response. This image-based approach can deliver results within one day of receiving the digital images from the patient's biopsy or surgical sample, helping clinicians make timely and informed treatment decisions. For more information, visit www.PATHOMIQ.com.

Myriad Genetics Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the upcoming launch of the Prolaris + AI Test at the end of May 2026, that the new AI metric will be available for all U.S. Prolaris Biopsy tests, outside of New York State, processed starting May 29, 2026, that the addition for New York State is expected to come soon, and other statements regarding future availability of the Prolaris + AI Test. These "forward-looking statements" are management's expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company's filings with the U.S. Securities and Exchange Commission, including the company's Annual Report on Form 10-K filed on February 24, 2026, as well as any updates to those risk factors filed from time to time in the company's Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.

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References:

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