VENTANA® PTEN (SP218) RxDx Assay

IVD For in vitro diagnostic use.
VENTANA<sup>®</sup> PTEN (SP218) RxDx Assay
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IHC stain of PTEN loss status greater than or equal to 90 percentage of viable malignant cells and no specific cytoplasmic staining

Driving diagnostic certainty for life-changing decisions in prostate cancer

The VENTANA® PTEN (SP218) RxDx Assay is the first and only immunohistochemistry (IHC) assay approved to identify metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer patients, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC) patients, who are eligible for combination treatment with TRUQAP® (capivasertib).1 TRUQAP is the first and only PTEN loss biology targeted treatment for these patients.2

Prostate cancer is the leading cancer diagnosis among men in the United States, other than skin cancers.3,4 Nearly all patients with prostate cancer in Stages 1-3 are expected to survive five years or more, while patients with Stage 4 prostate cancer have a five-year survival rate of about 38%.5 US incidence rates in 2025 were 245,000, an increase of 6.5% since 2022, with over 36,000 dying from the disease.6

Benefits at a glance

Benefits at a glance

The first FDA-approved IHC companion diagnostic test designed specifically to connect PTEN-deficient mAPMN/S prostate cancer patients with targeted therapy.1

Ready-to-use, clinically validated test designed to enable timely, reproducible results, backed by deep medical and scientific rigor and stringent development protocols.

PTEN is a tumor suppressor protein. Reduced or absent PTEN protein expression has been identified by immunohistochemical (IHC) analyses in several cancers, including prostate adenocarcinoma. Loss of expression of PTEN protein, also referred to as PTEN loss or PTEN deficiency, is associated with advanced-stage disease, faster disease progression, and reduced benefit from current standard-of-care treatments.7

Designed for use on a BenchMark instrument, the assay utilizes the OptiView DAB IHC Detection Kit to help achieve consistent and reliable results. This automation streamlines laboratory workflows and supports accurate assessments.

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    References 

    1. U.S. Food and Drug Administration. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) [Internet; cited 2026 May 20]. Available from: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools. 
    2. ESMO Daily Reporter. Is targeted therapy for PTEN-deficient metastatic hormone-sensitive prostate cancer on the horizon? [Internet; cited 2026 May 20]. Available from: https://dailyreporter.esmo.org/esmo-congress-2025/genitourinary-cancers/is-targeted-therapy-for-pten-deficient-metastatic-hormone-sensitive-prostate-cancer-on-the-horizon.
    3. National Cancer Institute. Cancer Stat Facts: Common Cancer Sites [Internet; cited 2026 May 20]. National Institutes of Health. Available from: https://seer.cancer.gov/statfacts/html/common.html. 
    4. National Cancer Institute. Prostate cancer—Health professional version [Internet; cited 2026 May 20]. U.S. Department of Health and Human Services, National Institutes of Health. Available from: https://www.cancer.gov/types/prostate . 
    5. National Cancer Institute. SEER*Explorer: Recent trends in SEER relative survival rates, 2004-2022* [Internet; cited 2026 May 20]. Surveillance, Epidemiology, and End Results Program. Available from: https://seer.cancer.gov/statistics-network/explorer/application.html?site=66&data_type=4&graph_type=2&compareBy=stage&chk_stage_106=106&relative_survival_interval=5&hdn_sex=2&race=1&age_range=1&advopt_precision=1&advopt_show_ci=on. 
    6. Cancer Tomorrow. Estimated number of new cases from 2022 to 2025 in U.S., Incidence, Males, age [0-85+], Prostate [Internet; cited 2026 May 20]. International Agency for Research on Cancer, World Health Organization. Available from: https://gco.iarc.fr/tomorrow/en/dataviz/tables?populations=840&cancers=27&years=2025&sexes=1.
    7. Fizazi K, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026;37(1):53-68.