Novel prostate cancer biomarker test launches on US market

Quest Diagnostics has partnered with Envision Sciences to commercially launch a novel prostate cancer biomarker test to help in identifying patients with more aggressive forms of the disease, Quest Diagnostics and the University of South Australia announced in separate news releases.^1,2

The investigative team plans to begin clinicaltrials of the biomarker test in Australia following positive outcomes with its use in the United States.

"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 vice president and general manager of Quest Diagnostics’ oncology franchise, Kristie Dolan, in a news release.¹ "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."

The novel test was developed and validated using the biomarkers Appl1, Sortilin, and Syndecan-1 that were studied by investigators at the University of South Australia, Adelaide. Data on the biomarkers were previously published in Pathology,³ which assessed 302 radical prostatectomy samples from 114 men with prostate cancer. Findings showed that the biomarker panel resulted in 22% of the tissue specimens analyzed being upgraded and 20% of the specimens being downgrading compared with grading assignments given by standard grading mechanisms from hematoxylin and eosin-stained (H&E) tissue evaluations.

Further data on the technology⁴ showed that the biomarker panel of Appl1, Sortilin, and Syndecan-1 showed greater efficacy in predicting clinical and biochemical recurrence compared with standard grading mechanisms. Compared with H&E-stained slides (C-statistic = .59), the slides that were immunohistochemistry-labelled for Appl1, Sortilin, and Syndecan-1 were more predictive of biochemical recurrence (C-statistic = .63). Further, the biomarker panel (C-statistic = .71) showed greater value in predicting clinical recurrence compared with H&E (C-statistic = .66).

“The biomarkers are remarkably sensitive and specific in accurately visualizing the progress of the cancer and confirming its grade. This discovery has led to the commercial development of a test designed to determine how advanced and aggressive the cancer is and whether immediate treatment is needed,” said Douglas A. Brooks in a secondary news release.² Brooks, a co-author of the 2 studies, is a research professor in molecular medicine at the University of South Australia.

The novel test in now available in the United States through Quest Diagnostics’ subspecialty pathology business AmeriPath. The investigative team plans to begin clinicaltrials of the biomarker test in Australia following positive outcomes with its use in the United States.

References

1. Quest Diagnostics launches novel prostate cancer test aimed at improving diagnosis and grading. News release. Quest Diagnostics. July 13, 2023. Accessed August 10, 2023. https://www.prnewswire.com/news-releases/quest-diagnostics-launches-novel-prostate-cancer-test-aimed-at-improving-diagnosis-and-grading-301876656.html

2. New prostate cancer biomarkers provide hope to millions of men. News release. University of South Australia. July 19, 2023. Accessed August 10, 2023. https://www.newswise.com/articles/new-prostate-cancer-biomarkers-provide-hope-to-millions-of-men?ta=home

3. Martini C, Logan JM, Sorvina A, et al. Aberrant protein expression of Appl1, Sortilin and Syndecan-1 during the biological progression of prostate cancer. Pathology. Published online August 20, 2022. Accessed August 10, 2023. doi:10.1016/j.pathol.2022.08.001

4. Logan JM, Hopkins AM, Martini C, et al. Prediction of prostate cancer biochemical and clinical recurrence is improved by IHC-assisted grading using Appl1, Sortilin and Syndecan-1. Cancers (Basel). Published June 16, 2023. Accessed August 10, 2023. doi:10.3390/cancers15123215