LynxDx is working to commercialize a prostate cancer urine diagnostic assay that is able to confidently prevent many unnecessary prostate biopsies. The test, called the MyProstateScore (MPS) is performed in a regulatory-compliant commercial laboratory.
MESSAGE FOR PATIENTS & CLINICIANS
WE ARE THE BEST
MPS IS THE MOST VALIDATED & BEST PERFORMING PROSTATE CANCER DIAGNOSTIC TEST
The work proposed in this application will fill critical holes in the field’s understanding of the utility of MPS within clinical practice. This work will serve to help drive adoption, expand the utility of the test into additional markets, and further its ability to improve clinical care as explained below.
MEASURES LEVELS OF TWO CANCER SPECIFIC GENES IN URINE
Long non-coding RNA with highly PCa specific expression
FDA approved test for risk stratification in patients with prior negative biopsy
TMPRSS2: ERG FUSION
Highly PCa specific gene fusion discovered by our group*
Most specific and validated tissue biomarker of prostate cancer
# of samples in
MPS RISK SCORE
WHAT IT IS
LynxDx provides the service of receiving urine, performing the MPS assay, and reporting results to clinicians for their interpretation. The end to end process is as follows:
Physician offices are supplied with collection kits that contain urine collection tubes filled with RNA preservation media, requisition form, instructions, and a prepaid envelope to send urine samples to the LynxDx laboratory for processing
Patient urine is obtained, transferred to the collection tube, and shipped to the LynxDx laboratory. Specimen is stable at room temperature for up to 5 days and up to 14 days if refrigerated.
Samples are received, accessioned and processed at LynxDx laboratory. RNA quantification is performed.
Clinical report is generated and faxed back to the ordering physician
Interpretation and clinical decision making based on the result is left to the clinician and patient.
Patient or insurance is billed for service
WE ARE ON A MISSION TO IMPROVE PATIENT CARE
LynxDx is a cancer diagnostics company with the mission to improve patient care by bringing important novel technologies into the market. LynxDx has IP generated by key discoveries made by its cofounders. With robust validation studies backing our technology, we are well positioned to disrupt the market.
HOW IT WORKS
The diagnostic performance of PCA3 and T2:ERG has been extensively validated in multiple studies comprised of thousands of patient samples [8–11]. While the two biomarkers had been separately validated [8,12], a study by Tomlins et al. in 2016 established and validated the MPS risk score algorithm in 1,225 samples . Additionally, a separate independent validation study was performed by Sanda et al. in 2017 on 561 samples  which corroborated the performance of MPS as a superb diagnostic tool for preventing unnecessary biopsies. These studies revealed that MPS is able to rule out 28% of biopsies with a sensitivity of 98% and negative predictive value (NPV) of 98%. With these performance numbers, MPS confers an unparalleled level of confidence for ruling out biopsies in patients suspected of having prostate cancer. In light of the fact that nearly all prostate biopsies (~85%) will not detect high-grade prostate cancer, usage of MPS to rule out unnecessary biopsies can have a significant positive impact on patient care.