IRVING, Texas — July 14, 2026
Caris Life Sciences has expanded its precision oncology portfolio with the launch of in-house PTEN immunohistochemistry (IHC) testing, enabling oncologists to identify patients with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer who may benefit from newly approved biomarker-guided therapy. The announcement follows the recent U.S. Food and Drug Administration (FDA) approval of capivasertib in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic prostate cancer, marking a major advancement in personalized cancer treatment. By integrating PTEN IHC testing into its extensive molecular diagnostics portfolio, Caris Life Sciences aims to provide clinicians with faster, more comprehensive biomarker insights that support precision treatment decisions. The new testing capability reflects the growing shift toward molecularly guided oncology, where therapy selection is increasingly based on tumor biology rather than clinical characteristics alone. As prostate cancer remains one of the most commonly diagnosed cancers among men, this innovation has the potential to improve treatment selection and clinical outcomes for thousands of patients worldwide.
PTEN Testing Enables Biomarker-Guided Treatment Selection
The newly introduced PTEN IHC assay is designed to detect PTEN protein loss, a key molecular alteration associated with activation of the PI3K/AKT signaling pathway, one of the most important biological drivers of prostate cancer progression. Approximately one in four patients with mAPMN/S prostate cancer exhibit PTEN-deficient tumors, which are associated with more aggressive disease progression and poorer clinical outcomes. Until recently, treatment decisions for metastatic hormone-sensitive prostate cancer relied primarily on clinical features rather than molecular biomarkers. With the FDA approval of capivasertib-based therapy, identifying PTEN deficiency has become increasingly important for selecting patients who are most likely to benefit from targeted treatment. By offering in-house PTEN IHC testing, Caris enables physicians to obtain timely biomarker results that support evidence-based therapeutic decisions while expanding access to precision oncology testing across clinical practice.
Comprehensive Molecular Profiling Strengthens Precision Oncology
The addition of PTEN IHC testing further expands Caris Life Sciences’ comprehensive portfolio of molecular diagnostic solutions, complementing its advanced next-generation sequencing (NGS) and multi-platform genomic profiling technologies. Conducted within the company’s CAP-accredited and CLIA-certified laboratories, the assay is designed to deliver rapid turnaround times while maintaining high analytical quality. Caris combines IHC testing, whole genome sequencing, whole exome sequencing, and whole transcriptome sequencing to provide clinicians with a more complete understanding of tumor biology. This integrated molecular profiling strategy enables oncologists to identify actionable biomarkers, match patients with targeted therapies, guide clinical trial enrollment, and support personalized treatment planning across multiple cancer types. As precision medicine continues evolving, comprehensive biomarker analysis is becoming increasingly essential for optimizing cancer care and improving long-term patient outcomes.
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Caris Advances AI-Driven Precision Cancer Diagnostics
The introduction of PTEN IHC testing reinforces Caris Life Sciences’ position as a leader in AI-powered precision medicine and advanced cancer diagnostics. By combining artificial intelligence, machine learning, and one of the world’s largest clinico-genomic databases, Caris continues developing innovative diagnostic technologies that improve early detection, diagnosis, treatment selection, disease monitoring, and pharmaceutical research. The company’s expanding portfolio includes comprehensive molecular profiling platforms such as MI Cancer Seek®, Caris Assure®, Caris MI Clarity™, Caris Chromoseq™, and Caris Detect™, supporting precision oncology across multiple disease settings. As biomarker-driven therapies become increasingly central to modern cancer treatment, Caris Life Sciences continues advancing personalized healthcare by delivering clinically actionable molecular insights that help physicians select the most effective therapies while improving outcomes for patients with advanced cancers.
Source: Caris Life Sciences press release
