TEST:

ExoDx™ Prostate (IntelliScore) Test

Methodology: A descriptive research centered on genetic biomarkers associated with the diagnosis of prostate cancer was conducted.The selection of articles comprised the period from 2019 to 2024, using as an inclusion criterion those available in the PubMed database, from the descriptor: Prostate cancer biomarkers being 519 articles, being selected only 15 Results Over the years, several studies have identified genetic tests such as BRCA1 and BRCA2, capable of identifying patients at high risk of developing prostate cancer.These findings culminated in the identification of new genetic biomarkers, categorized as blood and urinary.Urinary markers, such as Select MDX, MIPS, Exodx Prostate and PCA3-PCGm1, improve early diagnosis, reducing the need for invasive prostate biopsies, dispensing rectal touch.Already the blood markers, exemplified by the 4kscore test, associate themselves with algorithms, expanding their potential when employed in conjunction with magnetic resonance imaging and the prostate health index. Conclusion The introduction of genetic biomarkers in the context of prostate cancer represents a significant advance, providing subsidies to improve the detection, diagnosis and risk assessment associated with this neoplasia.Its application in clinical practice emerges as a facilitating tool in decision making regarding the indication of biopsies and rebiopsies, contributing to the reduction of invasive procedures and giving greater accuracy to the diagnostic process.

No abstract available

This retrospective analysis demonstrates that (a) EPI and mpMRI provide complementary, superior clinical benefits. (b) In real-world practice, physicians primarily use the EPI test prior to mpMRI. (c) EPI makes significant clinical impact in the first year of test use and analysis suggests benefits of repeat testing in subsequent years as future shared-biopsy decisions are made.

This analysis demonstrates that EPI testing provides significant clinical impact in the year during which the test is utilized and supports the need for additional EPI testing in subsequent years as future shared decisions regarding diagnostic prostate biopsy are made.

In the 2.5-year follow-up study, many AA men in the SOC control cohort remained undiagnosed. This raises concerns about the potential for these individuals to be missed in the clinic. This data emphasizes the importance of utilizing the EPI test for risk assessment of high-risk prostate cancer in AA men.

In this review, we will critically describe the different types of EVs, the methods for their enrichment and characterization, and their biological role in cancer. Then, we will specially focus on the parameters to be considered for the translation of EV biology to the clinic laboratory, the advances already made in the field of EVs related to cancer diagnosis and treatment, and the issues still pending to be solved before EVs could be used as a routine tool in oncology.

We also briefly discuss a few promising biofluid marker candidates (DNA methylation, micro-RNAs) which are not in clinical application. As no single assay is perfect, we envision that a combination of biomarkers, together with imaging, will become the preferred practice.

Regarding the detection of csPCa, 4K had the highest diagnostic performance among the commercial liquid biomarkers. Based on the optimal thresholds calculated by the present meta-analysis, 4K had the highest sensitivity and PHI had the highest specificity for detecting csPCa. Nevertheless, clinical decision-making requires combination strategies between liquid and imaging biomarkers.

This analysis demonstrates the high negative predictive value of both the OPKO4K score and ExoDX IntelliScore independently while demonstrating that the combination of an OPKO4K score, an ExoDX IntelliScore, and MRI increases predictive capability for biopsy confirmed prostate cancer.

No abstract available

Coverage of novel CaP biomarkers are relatively robust for Medicare plans but sparse for non-Medicare plans, with the majority of non-Medicare plans requiring prior authorization. Non-Medicare eligible men may face significant barriers to obtaining these tests.

"Bio-Techne Corporation...announced that Exosome Diagnostics...has reported interim results from a previously published prospective, randomized study of more than 1,000 patients aimed at evaluating the clinical utility of the ExoDx™ Prostate Test over a 5-year follow-up period. This study adds to the body of published evidence on the ExoDx Prostate Test. The results came out in a peer-reviewed paper published today in Prostate Cancer and Prostatic Diseases."

P=N/A; This follow-up analysis captures subsequent biopsy outcomes and demonstrates that men receiving EPI low-risk scores (<15.6) significantly defer the time to first biopsy and remain at a very low pathologic risk by 2.5-years after the initial study. The EPI test risk stratification identified low-risk patients that were not found with the SOC.

mpMRI outperformed both ExoDx and PSAD for detection of high-grade prostate cancer but with considerable trade-off in sensitivity to ExoDx. Incorporating the ExoDx biomarker with MRI resulted in the best predictive ability, suggesting there may be a synergistic detection effect with combination approach. This data suggests MRI alone may not be sufficient in certain cases and that employing the ExoDx test could provide added benefit for both biopsy decision-making and predictive capability.

The COVID-19 pandemic accelerated major shifts to telehealth and increased use of At Home Testing. The ExoDx Prostate (EPI) At Home Collection Kit was successfully developed and employed to help men (>50 years old) with elevated PSAs (2 – 10 ng/ml) considering initial or repeat diagnostic biopsy but with pandemic-related fears of visiting offices/hospitals or wanting to avoid long distance travel from rural areas. As COVID becomes manageable and clinical practices have opened, some pandemic-adopted approaches remain relevant: the ExoDx™ Prostate, (EPI) At Home Collection Kit is one such approach.

EV PSMA immuno-capture provides a robust approach to expanding the panel of PCa biomarkers that can be incorporated into clinical grade PCa urine EV assays, supporting the translation of pre-clinical discovery into clinical practice.

"Bio-Techne Corporation...announced that a newly finalized local coverage determination (LCD) from National Government Services, Inc., a Medicare Administrative Contractor, includes coverage for the ExoDx™ Prostate Test from Exosome Diagnostics, a Bio-Techne brand. The updated policy now covers an annual ExoDx Prostate Test for men who already had a negative biopsy but are thought to be at high risk for prostate cancer and are considering a repeat biopsy. The coverage will go into effect March 1, 2023."

Another potential direction that has emerged to aid in the CaP diagnosis include multi-parametric magnetic resonance imaging (mpMRI) and bi-parametric magnetic resonance imaging (bpMRI), which in conjunction with clinically validated biomarkers may provide a better approach to predict clinically significant CaP at diagnosis. In this review, we discuss some of the adjunctive biomarker tests along with newer imaging modalities that are currently available to help clinicians decide which patients are at risk of having high-grade CaP on prostate biopsy with the emphasis on clinical utility of the tests across African American (AA) and Caucasian (CA) men.

ExoDx was historically validated in an imaging naïve cohort.3 Prior retrospective evaluation of double negative MRI + ExoDx virtually excludes csPCa.2 Within our data, there was no identified ExoDx score useful for delineating prostate cancer vs no prostate cancer.

In a preliminary direct comparison, the EPI biomarker assay provides superior sensitivity and negative predictive value for assessing the risk of clinically significant cancer prior to biopsy.

The ExoDx Prostate (EPI) At Home Collection Kit was successfully developed and employed to help men (>50 years old) with elevated PSAs (2 – 10 ng/ml) with pandemic-related fears of office/hospital visits considering initial or repeat prostate biopsy or wanting to avoid long distance travel from rural areas. The ExoDx At Home Kits provides an easy non-invasive, non-DRE urine test for genomic risk assessment of aggressive cancer. At Home testing is poised to be increasingly utilized (cancer biomarkers, benign urology diseases) and become an integral part of urology telehealth.

The current interim analysis provides longer term evidence that men with low-risk EPI scores are at much-reduced risk of having higher grade prostate cancer including clinically significant ≥GG3.

P=N/A; N=750; Recruiting; Sponsor:Exosome Diagnostics, Inc.

Serum, urine, and tissue-based biomarkers are increasingly being incorporated into the clinical care paradigm, but there is still a limited understanding of how to use them most effectively. In the current article, we review test characteristics and clinical performance data for both serum &lsqb;4 K score, prostate health index (phi)] and urine &lsqb;SelectMDx, ExoDx Prostate Intelliscore, MyProstateScore (MPS), and PCa antigen 3 (PCA3)] biomarkers to aid decisions regarding initial or repeat biopsies as well as tissue-based biomarkers (Confirm MDx, Decipher, Oncotype Dx, and Polaris) aimed at risk stratifying patients and identifying those patients most likely to benefit from treatment versus surveillance or monotherapy versus multi-modal therapy.

"Bio-Techne Corporation...announced that Exosome Diagnostics...will have a major scientific presence at the annual American Urological Association Conference (AUA) taking place May 13-16 in New Orleans, LA. Exosome Diagnostics will have two poster presentations, including a podium presentation, six in-booth scientific presentations...Additional presentations include results of the ExoDx™ Prostate test clinical utility study as well as a 2.5 year follow-up and interim analysis of subjects who participated in the study and will conclude with the combined performance of the ExoDx Prostate test and MRI in the early detection of prostate cancer."

A new model was generated by combining the EPI score and MRI result (training (N=116) and test (N=29), resulting in an increased AUC (0.88) compared to either EPI (0.68) or MRI alone (0.75). Conclusions : The combination of MRI and EPI is better than either alone and suggests that this combined approach is more clinically useful when conducted before the Bx decision.

P=N/A; N=350 --> 150 | Trial completion date: Jul 2022 --> Sep 2021 | Recruiting --> Terminated | Trial primary completion date: Jul 2022 --> Sep 2021; project reprioritization

The use of urinary biomarkers hasimproved of clinically significant prostate cancerdiagnosis. Their use reduces the number of unnecessarybiopsies and avoids overtreatment of indolentprostate cancer.

P=N/A | "This is the first clinical study reporting on the performance of EPI-CE. We demonstrate that EPI-CE provides information beyond standard clinical parameters and provides a better risk assessment prior to MRI, of patients suspected of prostate cancer, than the commonly used multiparametric risk calculators."

"Liquid biomarkers can be useful tools for aiding in risk stratification prior to prostate biopsy. Use of such tests should be individualized based on a thorough knowledge of supporting evidence and the goals of the patient and physician. Further study should prioritize evaluation of such biomarkers in men with African ancestry."

"Bio-Techne Corporation...announced an important publication in World Journal of Urology, entitled Pre–diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post–prostatectomy pathology outcome...The significance of this study is that in men with an EPI score below the cut-point of 15.6, the ExoDx Prostate test could prevent low-risk men from proceeding to radical prostatectomy."

P=N/A | "The EPI urine biomarker outperformed the multivariate risk calculators in a homogenous risk group of pre-biopsy men. The EPI score was associated with low-risk pathology post-RP, with potential implications on informing AS decisions."

"EPI is a noninvasive, easy-to-use, urine exosome-RNA assay that has been validated across 3 independent prospective multicenter clinical trials with 1212 subjects. The test can discriminate high-grade (≥GG2) from low-grade (GG1) cancer and benign disease. EPI effectively guides the biopsy-decision process independent of PSA and other standard-of-care factors."

P=N/A; Trial completion date: Jul 2021 --> Jul 2022 | Trial primary completion date: Jul 2021 --> Jul 2022

P=N/A; Recruiting --> Completed | N=300 --> 120

"In this article, we will review several of those more recent diagnostic markers (4Kscore®, [-2]proPSA and Prostate Health Index, SelectMDx®, ConfirmMDx®, Progensa® Prostate Cancer Antigen 3, Mi-Prostate Score, ExoDx™ Prostate Test, the Stockholm3 test and ERSPC risk calculators) and prognostic markers (OncotypeDX® Genomic Prostate Score, Prolaris®, Decipher® and ProMark®). We will also address some new liquid biopsy approaches - circulating tumour cells and cell-free DNA - with a potential role in metastatic castration-resistant prostate cancer and will briefly give some future perspectives, mostly outlooking epigenetic markers."

"Published data were used to compute the number of unnecessary biopsies avoided and number of GG ≥2 cancers missed if the biomarker had been used clinically to select for prostate biopsy. The evidence review is preceded by a primer on these and other clinically-relevant summary statistics."

The current study provides initial evidence that the EPI test, validated for pre-Bx HGPCa risk stratification, may have value for assessing RP pathologic upgrading in GG1 cancer. The EPI urine liquid biomarker test assay might more appropriately assess tumor heterogeneity and thus have a role in AS decision-making in newly diagnosed GG1 prostate cancer.

In combination with traditional factors like age and baseline PSA, the stepwise addition of OPKO4K combined with ExoDx test significantly improves decision for the need of prostate biopsy. Incorporation of both tests prior to MRI provides outstanding discrimination between men with a low versus high probability of positive prostate biopsy. Utilizing MRI with combination of biomarkers has high predictive capability in men with elevated PSA.

Learning objectives Understand the basics of exosomes and exosome-based diagnostic tools; Learn why an exosome-based liquid-biomarker approach offers an ideal platform for the early risk assessment and potentially earlier detection of prostate cancer; Compare the performance of various biomarkers and how they fit into clinical practice; Determine which patients would most benefit from the ExoDx Prostate (EPI-CE) test as risk assessment tool.

Gene expression patterns were compared with exosomal gene signatures extracted from human ovarian patient plasma and found to express similar patterns. These results support the diagnostic potential of using exosomal genetic signatures to detect early metastatic development and to facilitate longitudinal tracking of tumor progression.

"This study highlights the potential for developing broadly applicable CaP diagnostic biomarker panels for aggressive prostate cancer using our novel gene expression assay platform."