LYNX DX

MyProstateScore

(MPS)

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.

MYPROSTATESCORE

MEASURES LEVELS OF TWO CANCER SPECIFIC GENES IN URINE

PCA3

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

MPS PERFORMANCE

98%

Negative
predictive value

98%

Sensitivity

27%

Biopsies
prevented

1,700

# of samples in
performance
studies

TECHNOLOGY

URINE

PCA3

T2:ERG

BLOOD

PSA

MPS RISK SCORE

WHAT IT IS

PRODUCT

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

PERFORMANCE

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 [10]. Additionally, a separate independent validation study was performed by Sanda et al. in 2017 on 561 samples [11] 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.