Chicago, Illinois, USA: The future of cancer treatment is not just about developing new medicines. It is about ensuring the right patient receives the right treatment at the right time.
This week, that future moved one step closer to reality.
Roche, the pharma company announced that the U.S. Food and Drug Administration has approved the VENTANA PTEN (SP218) RxDx Assay, the first companion diagnostic test designed to assess PTEN protein loss in people living with prostate cancer.
This is more than a regulatory milestone.
It is a breakthrough that gives physicians a powerful new tool to identify patients who may benefit from a targeted treatment approach using AstraZeneca’s TRUQAP (capivasertib). For years, doctors have known that PTEN plays a critical role in controlling tumor growth. When this tumor-suppressing protein is lost, cancer often becomes more aggressive, progresses faster, and responds less effectively to standard therapies.
Yet despite its importance, identifying PTEN-deficient patients and matching them with targeted therapies remained a challenge.
Today, that challenge has a solution.
The newly approved VENTANA PTEN assay enables pathologists to determine whether a prostate tumor lacks PTEN protein expression. This information can help identify patients who may be eligible for treatment with TRUQAP in combination with abiraterone acetate.
The significance of this advancement becomes even clearer when looking at the numbers.
Prostate cancer remains one of the most commonly diagnosed cancers among men in the United States. Among patients with metastatic hormone-sensitive prostate cancer, approximately 25% have PTEN-deficient tumors. These patients often face a more aggressive disease course and fewer effective treatment options.
The average survival following a diagnosis of newly metastatic prostate cancer is estimated at around five to six years. For these patients and their families, every improvement in treatment selection can make a meaningful difference.
The FDA approval was supported by findings from the CAPItello-281 clinical trial.
In the study, Roche’s assay was used to identify patients with PTEN-deficient tumors before enrollment.
The results demonstrated that patients receiving the TRUQAP combination therapy experienced a statistically significant and clinically meaningful reduction in disease progression. This achievement reflects a broader transformation taking place across oncology.
Cancer treatment is rapidly evolving from a one-size-fits-all approach to precision medicine, where therapies are guided by the unique biological characteristics of each patient's disease. Companion diagnostics are becoming the bridge between scientific discovery and personalized care.
By helping clinicians identify the patients most likely to benefit from a therapy, these tests improve treatment decisions and maximize clinical outcomes.
The approval also highlights the growing collaboration between diagnostics and therapeutics.
Foundation Medicine, an independent affiliate of Roche, is among the laboratories utilizing the VENTANA PTEN assay to support healthcare providers in identifying eligible patients.
Together, diagnostics and targeted therapies are creating a more precise and effective cancer care ecosystem.
As healthcare leaders, our mission extends beyond innovation itself.
It is about translating scientific breakthroughs into real-world benefits for patients.
The approval of the VENTANA PTEN (SP218) RxDx Assay represents exactly that kind of progress; turning molecular insights into actionable treatment opportunities. For thousands of men facing advanced prostate cancer, this approval brings new hope, greater precision, and the possibility of better outcomes.
About Roche
Roche is one of the world's leading healthcare companies, operating across pharmaceuticals and diagnostics. Founded in 1896 in Basel, Switzerland, the company serves patients in more than 150 countries. Through innovations in oncology, neuroscience, infectious diseases, cardiovascular care, and personalized medicine, Roche continues to advance its mission of improving lives through science, technology, and precision healthcare.
Reference:
https://www.roche.com/media/releases/med-cor-2026-06-12
https://www.towardshealthcare.com/insights/cancer-diagnostics-market-sizing
https://www.towardshealthcare.com/insights/tumor-fluid-biopsy-market-sizing
https://www.towardshealthcare.com/insights/cancer-supportive-care-drugs-market-sizing
https://www.towardshealthcare.com/insights/cancer-biopsy-market-sizing