Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer

• The new VENTANA® PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with TRUQAP.
• In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments.¹
• The FDA approval reinforces Roche’s leadership in companion diagnostics and its ongoing commitment to expanding personalized healthcare to improve patient outcomes.

INDIANAPOLIS, June 12, 2026 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANA® PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive U.S. Food and Drug Administration (FDA) approval for determining PTEN protein loss, also known as PTEN deficiency, in tumors of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca’s targeted therapy TRUQAP® (capivasertib).

PTEN is a tumor-suppressor protein, and loss of PTEN is commonly observed in a variety of cancers.² Roche’s test enables patients with PTEN-deficient prostate cancer to access a combination treatment with TRUQAP. TRUQAP provides a new, first-line treatment option for patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC).³

Metastatic hormone-sensitive metastatic prostate cancer (mHSPC) is an aggressive form of prostate cancer for which targeted combination treatments were previously not available. The average length of survival after new, metastatic-prostate-cancer diagnosis is about five to six years.⁴ About 25% of patients with mHSPC have PTEN-deficient tumors as evaluated by IHC.¹

Foundation Medicine, an independent affiliate of the Roche Group, is one laboratory using the VENTANA® PTEN (SP218) RxDx Assay companion diagnostic kit to help healthcare providers identify patients with PTEN protein loss.
 

About the VENTANA® PTEN (SP218) RxDx Assay

The VENTANA® PTEN (SP218) RxDx Assay is a qualitative immunohistochemical assay intended to be used in the assessment of PTEN protein in prostate adenocarcinoma. The OptiView DAB IHC Detection Kit is used for staining on a BenchMark ULTRA instrument. The assay is indicated as an aid in identifying patients with prostate adenocarcinoma who may be eligible for treatment with TRUQAP in combination with abiraterone acetate in accordance with the approved therapeutic product labeling.

The approval of the VENTANA® PTEN (SP218) RxDx Assay is based on the results of the CAPItello- 281 clinical study where it was used as the enrollment assay to identify patients whose tumors exhibited PTEN loss. The clinical cutoff for PTEN loss status is ≥90% of viable malignant cells with no specific cytoplasmic staining. PTEN-loss status is based on the pathologist’s observation of an absence or presence of PTEN expression within prostate adenocarcinoma.⁵ Patients who received combination therapy with TRUQAP experienced a reduction in disease progression.¹

About Roche

Roche is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. 

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. 

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

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