UC San Diego Health Launches First US Blood Test for Testicular Cancer, Setting New Standard for Lab Diagnostics
The CAP- and CLIA-validated microRNA-371a-3P assay promises earlier detection, fewer CT scans, and more precise treatment decisions for a high-risk patient population.
According to a press release, UC San Diego Health has become the first health system in the United States to offer a clinically validated blood test for testicular cancer. This advance could potentially redefine diagnostic workflows, reduce reliance on imaging, and sharpen treatment decisions for a patient population that often faces both overtreatment and missed recurrences.
The assay, more than a decade in development, measures microRNA-371a-3P, a biomarker shown to detect the presence of testicular cancer cells with about 90% accuracy. Until now, clinicians and clinical laboratories have had limited tools to determine which patients require surgery, chemotherapy, or simply surveillance, especially when imaging is inconclusive.
“This CAP and CLIA clinical validation process and test implementation allows us to translate years of research findings into clinical decisions that can genuinely help patients,” said Sarah Murray, PhD, director of medical genetics and genomics at the UC San Diego Center for Advanced Laboratory Medicine and the laboratory leader who oversaw the test’s validation. “The rigorous standards we’ve met ensure that this test is reproducible, reliable and has analytic validity.”
Diagnostic Gap Labs Have Long Aimed to Close
Testicular cancer strikes roughly 10,000 people annually, primarily men between 18 and 45, yet existing serum markers fail to capture the majority of cases. As a result, laboratories and oncologists have historically struggled with staging uncertainty, unnecessary chemotherapy, and delayed recognition of recurrence. About one-third of patients experience relapses after orchiectomy despite normal CT imaging.
The press release explained that the biomarker’s sensitivity and specificity offer a clearer, earlier signal of active cancer biology—information that can materially change treatment plans.
Further, the test can be used across the care continuum. Before surgery, it can help confirm whether an abnormal testis is malignant and guide surgical decision-making. Post-operatively, it can help determine which patients truly need systemic therapy or further intervention. During surveillance, it may detect recurrence earlier than imaging, allowing less intensive and more precisely timed treatment.
For laboratories, one of the most consequential implications is the potential to reduce the reliance on repeated CT scans, as they carry radiation exposure, cost burdens, and logistical challenges. A validated blood-based alternative, if adopted more widely, could shift surveillance algorithms across health systems.
A Model for Translational Collaboration
The test is currently available for patients at UC San Diego Health and will open to external referrals later this year, allowing outside clinicians and pathology departments to submit samples. It is fully CAP-accredited and CLIA-certified, positioning it for broader adoption by cancer centers seeking higher-resolution molecular insight without expanding imaging capacity.
Diane Simeone, MD, director of the Moores Cancer Center at UC San Diego Health noted that international patient inquiries have already begun and emphasized the test’s potential to recalibrate global standards for testicular cancer management.
“This breakthrough represents the kind of investment in innovation that can save lives while improving quality of life for cancer survivors,” said Diane Simeone, MD, director of the Moores Cancer Center at UC San Diego Health. (Photo credit: UC San Diego Health)
For the urology and oncology teams, the test represents years of translational research. For laboratories, it represents a milestone in bringing microRNA-based diagnostics into routine clinical use.
Integrating Results into Multidisciplinary Care
Each test result will feed into UC San Diego Health’s molecular tumor board, a multidisciplinary group that meets every two weeks to review every patient case and interpret biomarker findings in the context of clinical, imaging, and pathological data. For laboratory professionals, this embedded oversight ensures that results are used appropriately and helps refine test performance insights over time.
For labs nationwide, the launch signals a turning point: a real-world, regulated microRNA test with immediate clinical impact—and a template for how laboratory medicine can lead in closing long-standing diagnostic gaps.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
—Janette Wider
