# Urine Diagnostic Tool for the Detection of High-grade Prostate Cancer

> **NIH NIH R44** · LYNX DX, INC. · 2020 · $1,004,315

## Abstract

PROJECT SUMMARY / ABSTRACT
The proposed research applies scientific advancements in cancer biology and biotechnology to reduce the
pain and suffering caused by prostate cancer. The current approach to prostate cancer diagnosis involves
screening with prostate serum antigen (PSA), a low specificity assay with a significant false positive rate. In
current screening practice, men with elevated PSA are referred for transrectal biopsy, which is an invasive
procedure associated with risk of serious complications. However, as a result of limited PSA performance, only
10-15% of the one million biopsies performed annually will detect clinically significant cancer. Better diagnostic
tools would eliminate the need for biopsy in the majority of cases. In Phase I, we show that measuring the
urine levels of two cancer-specific genes, the TMPRSS2:ERG (T2:ERG) fusion and PCA3, serve as a highly
accurate biomarker assay. In our proof-of-concept work we successfully: (i) validated diagnostic performance
for urine levels of T2:ERG, (ii) developed an algorithm combining urine levels of PCA3 and T2:ERG with serum
PSA to generate the MPS risk score, (iii) validated performance of MPS in a 1,225 patient cohort, determined
the model used for the MPS assay, and demonstrated its ability to prevent 28% of biopsies with >98%
accuracy, and (iv) shifted the assay from a limited-throughput proprietary platform to a more cost-effective
qPCR method that enables integration of additional targets.
Current attempts to fill this clinical need perform poorly, are understudied in key populations, and have low
specificity for high-grade cancer. To have maximal impact and continue to work towards commercialization, we
will study MPS in these increasingly pertinent contexts in Phase II. In Aim 1 we characterize performance of
MPS in relation to multi-parametric MRI, an imaging technology that has become prominent in the prostate
cancer diagnostic workflow. The capacity of biomarkers to either replace or work synergistically with mpMRI
has not been sufficiently described. In Aim 2 we identify and validate optimal parameters for MPS testing in
African Americans, a demographic with elevated cancer incidence and mortality. In Aim 3 we integrate
additional biomarkers to better distinguish between low-grade and high-grade cancers. Instead of being
treated, men with low-grade caner are often serially monitored with burdensome procedures including biopsy.
Biomarker genes used now are not specific to high-grade cancer, thus an improved assay including such high-
grade associated genes is needed.
Given the prevalence of prostate cancer resulting in one million prostate biopsies each year, and the potential
for improvement over the currently flawed diagnostic approach, this clinically impactful work has great promise
as a successful commercial opportunity.

## Key facts

- **NIH application ID:** 10081058
- **Project number:** 1R44CA254692-01
- **Recipient organization:** LYNX DX, INC.
- **Principal Investigator:** Yashar Sharifi Niknafs
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,004,315
- **Award type:** 1
- **Project period:** 2020-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10081058

## Citation

> US National Institutes of Health, RePORTER application 10081058, Urine Diagnostic Tool for the Detection of High-grade Prostate Cancer (1R44CA254692-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10081058. Licensed CC0.

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