Quest Diagnostics 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. Physicians in the United States, with the exception of New York, may order the test starting today.

Envision Sciences is an Australian-based clinical diagnostics company developing a pipeline of biomarker-based cancer diagnostic and prognostic tests in tissue and blood.

Developing Quest’s New Test

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 staining technology and novel biomarkers (named EV1, EV2 and EV3). Recently published data in Pathology 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 hematoxylin and eosin-stained tissue alone. (1)

Prostate cancer is one of the most prevalent and deadly cancers affecting men. According to the American Cancer Society, about one out of every eight men will be diagnosed with prostate cancer during his lifetime. (2) 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. (3)

“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,” says 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.”

Quest Diagnostic specialty pathology businesses, AmeriPath and Dermpath Diagnostics businesses, provide subspecialty expertise based largely from serving community cancer centers, according to the company.

“Envision Sciences welcomes this relationship with Quest Diagnostics. We believe this collaboration aligns us with the world leader in prostate cancer testing,” says Envision CEO Peter Pursey. “Our patented technology provides a novel approach to visualizing prostate cancer tissue and improving accuracy in grading the cancer by pathologists. We expect the test to enhance current prostate cancer histology practice and improve the information available to clinicians, enabling them to better align cancer grades with treatment options.”


1 Martini, C., Logan, J. M., Sorvina, A., Gordon, C., Beck, A. R., S-Y. Ung, B., Caruso, M. C., Moore, C., Hocking, A., Johnson, I. R. D., Li, K. L., Karageorgos, L., Hopkins, A. M., Esterman, A. J., Huzzell, C., Brooks, R. D., Lazniewska, J., Hickey, S. M., Bader, C., … Brooks, D. A. (2022). Aberrant protein expression of APPL1, Sortilin and syndecan-1 during the biological progression of prostate cancer. Pathology, 55(1), 40–51. 

2 Key Statistics for Prostate Cancer | Prostate Cancer Facts 

3 Can Prostate Cancer Be Found Early?