Quest Diagnostics has launched a novel prostate cancer biomarker test through its subspecialty pathology business, AmeriPath, in collaboration with Envision Sciences. The new, tissue-based test service is intended to address the pressing clinical need for tests to help identify and differentiate potentially aggressive cases of prostate cancer in men.
Quest developed and validated the laboratory test under an intellectual property license agreement with Envision for use of Envision's proprietary biomarker and immunohistochemistry technology, which includes Envision's unique staining technology and novel biomarkers (named EV1, EV2 and EV3). Recently published data shows that 22% of tissue specimens examined with a panel based on the three Envision biomarkers and technology were upgraded, and 20% were downgraded, as compared to the conventional assessment of pathologic evaluation based on haematoxylin and eosin-stained tissue alone.
Prostate cancer is one of the most prevalent and deadly cancers affecting men. A recent Quest Diagnostics Health Trends study showed that, more than two years after the COVID-19 pandemic began, diagnoses of prostate and breast cancer continue to lag behind pre-pandemic levels, suggesting more people are living with undiagnosed cancers now than prior to the pandemic. Although it is one of the most common cancers globally, existing prostate cancer testing methods, particularly for early, lower grade stages, have limited accuracy across pathologists.
"Our goal for this innovative prostate biomarker test is to improve the accuracy of grading prostate cancer biopsies. We expect this service to help fill a clinical gap affecting millions of men for staging, diagnosis and treatment for prostate cancer," said Kristie Dolan, Vice President and General Manager, Quest Diagnostics Oncology Franchise. "Through our relationship with Envision, we are excited to broaden access to this innovative technology. With Quest's national scale and industry-leading prostate cancer portfolio, we will be able to reach a larger number of patients and provide them with diagnostic insights to inform their treatment decisions."
Envision Sciences is an Australian-based clinical diagnostics company developing a pipeline of biomarker-based cancer diagnostic and prognostic tests in tissue and blood. The test is now available in the US.