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miR Sentinel™
Prostate Cancer Test
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WhymiR Sentinel

Detect and classify prostate cancer accurately with the miR Sentinel™ Prostate Cancer Test: a breakthrough, pain-free, comprehensive, simple urine test

Replacing Prostate Screening Tests: The Standard of Care that Doesn’t Meet your Standards

In addition to being extremely invasive and potentially leading to infection, urinary dysfunction, and overtreatment, the PSA test and biopsy combination has just a 44% Sensitivity level—making it highly inaccurate and necessary to repeat often.

Although elevated PSA levels can be an indicator of the presence of prostate cancer, many other factors not related to cancer can return an elevated PSA test.

The positive predictive value of elevated PSA for prostate cancer is less than 30%.
Medical literature shows that 7 out of 10 prostate biopsies are deemed unnecessary.
The false negative rate of 12-core biopsy is more than 30%.

How Does It Work

Molecular Diagnostic Prostate Cancer Testing

Unlike other available blood and urine tests, the miR Sentinel Prostate Cancer Test characterizes the entire prostate, allowing for more accurate results. If cancer is present, the results classify a patient’s condition into categories describing the risk level of developing aggressive disease.

The prostate naturally releases molecules into urine, including several different kinds of genetic material that vary depending on the presence and severity of prostate cancer.   We extract and measure these fragments, known as small non-coding RNAs, using gene expression technology and a proprietary algorithm.The miR Sentinel Prostate Cancer Test is a standalone test –it does not rely on PSA or biopsy material.

The miR Approach

Accurate Classification Guides Clinical Pathways

miR’s unique sncRNA extraction and interrogation techniques coupled with an advanced proprietary algorithm will allow physicians to confidently diagnose and classify prostate cancers with just one urine sample, reducing unnecessary prostate cancer diagnostic procedures and treatments.

Multiple peer-reviewed journals and validation studies have shown the extraordinary sensitivity and specificity of miR’s molecular diagnostic prostate cancer testing and monitoring technology.

The Current Standard of Care

Prostate Serum Antigen:

PSA prostate cancer screening testing assesses the level of PSA in a man’s blood. Approximately 70% of elevated PSAs are not associated with Prostate Cancer (false positive).

The risk of prostate cancer increases as PSA level increases, but there is no PSA level below which the risk of prostate cancer can be ruled out. Since elevated PSA is not solely associated with prostate cancer, too many men experience a false positive PSA result when the test is used for detecting prostate cancer.

As a result, men may undergo unnecessary, painful, and potentially harmful biopsy due to an elevated PSA level that frequently suggests cancer is present when it is not (false positive). On the other hand, a low PSA score does not necessarily confirm that cancer is not present, leading to the potential to miss cancer at screening (false negative).

Biopsy:

A prostate cancer biopsy is performed by a urologist and involves inserting multiple needles into a man’s prostate, either through the rectal wall or through the perineum, to collect a series of tissue samples. A positive core needle biopsy definitively detects a man with Prostate Cancer and can determine if his cancer is progressing.

A standard prostate cancer biopsy can miss up to 30% of cancer (false negative), which is why providers often recommend two or more biopsies plus imaging to be confident of a diagnosis.

DRE:

A DRE is a procedure in which a doctor puts a gloved, lubricated finger into a man’s rectum to feel the prostate gland.  The invasiveness and feelings of discomfort and dread associated with this experience cause many men to avoid this type of screening.

Biopsy:

A core needle biopsy is performed by a urologist and involves inserting multiple needles into a man’s prostate to collect a series of tissue samples.  The nature of this invasive procedure is associated with painful and dangerous risks.

Dangerous

Around 40% of biopsies lead to side effects such as infection, urinary bleeding, or rectal bleeding—with the complication rate rising as high as 57% in men with 24-sample biopsies. Over 9% of men end up in the Emergency Room after having a biopsy.

Harvard Health Publishing - Harvard Medical School
The Prevention and Treatment of the More Common Complications Related to Prostate Biopsy Update (AUA Task force 2016)

Expensive

The average cost for an uncomplicated biopsy without side effects is about $1700. Around 40-50% of biopsies lead to side effects such as infection and urinary or rectal bleeding, and over 9% of men end up in the Emergency Room after having a biopsy. These complications, in addition to being dangerous, can drive costs up to around $5800 per event.

Harvard Health Publishing - Harvard Medical School
The Prevention and Treatment of the More Common Complications Related to Prostate Biopsy Update (AUA Task force 2016)

Wasteful

The inaccuracy of Prostate Cancer screening using PSA levels causes significant waste in our medical system. Up to 70% of elevated PSAs are not associated with prostate cancer, but still lead to prostate biopsies and their related complications, costs, and inefficiencies. If doctors and patients had more reliable information which provided confidence in screening for prostate cancer, many of these biopsies could be avoided, saving time, money, and stress.

All in all, the current standard of care is invasive, inaccurate, expensive, overly complicated due to the multitude of steps and time required for proper diagnosis.

Make Change

A Molecular Method for Prostate Cancer Detection and Classification

The miR Sentinel™ Prostate Cancer Test can add a valuable option to augment the currently available toolset in prostate cancer detection, offering dynamic risk stratification of prostate cancer.

Non-Invasive

The miR Sentinel™ Prostate Cancer Test requires only a single, contact-free urine specimen.

Accurate

The miR Sentinel™ Prostate Cancer Test is undergoing validation studies to deliver accurate results.

Simple

miR Sentinel™ Prostate Cancer Test answers these questions with clarity when you need it most, with a simple urine test

Comprehensive

The first single test to detect the presence of prostate cancer and classify it, if it is present

THE CURRENT STANDARD OF CARE

Invasive
Inaccurate
Expensive
Complicated

Inaccurate

Invasive

Painful

Expensive

Dangerous

Wasteful

How does it work?

Unlike other available blood and urine tests, the miR Sentinel Prostate Cancer Test characterizes the entire prostate, allowing for more accurate results. If cancer is present, the results classify a patient’s condition into categories describing the risk classification of the tumor.

The prostate naturally releases molecules into urine, including several different kinds of genetic material that vary depending on the presence and severity of prostate cancer.   We extract and measure these fragments, known as small non-coding RNAs, using gene expression technology and a proprietary algorithm. The miR Sentinel Prostate Cancer Test is a standalone test – it does not rely on imaging, PSA, or biopsy material.

No Molecular Evidence of Prostate Cancer

This result indicates that the patient finding shows No Molecular Evidence of Prostate Cancer.

Low-Risk

This result indicates that the patient presents Molecular Evidence of Low-Risk Prostate Cancer, which is consistent with the NCCN Very Low and Low Risk Groups

Moderate Risk

This result indicates that the patient presents Molecular Evidence of Moderate-Risk Prostate Cancer, which is consistent with the NCCN Favorable Intermediate Risk Group

Elevated Risk

This result indicates that the patient presents Molecular Evidence of Elevated-Risk Prostate Cancer, which is consistent with the NCCN Unfavorable Intermediate, High, and Very High Risk Groups

Current Standards Are Failing Patients, Physicians, Health Systems, And Payors.

Inaccurate
Invasive
Dangerous
Expensive
Wasteful

ThemiR Standard

ofCare

All in all, the current standard of care is invasive, inaccurate, expensive, overly complicated due to the multitude of steps required for proper diagnosis.

The miR Sentinel Prostate Cancer Test has been validated to be over 90% accurate. What does this mean for you?

The miR Sentinel Prostate Cancer Test has been validated to be over 90% accurate. What does this mean for you?

ASK YOUR PROVIDER

Learn more about accessing the miR Sentinel™ Prostate Cancer Test

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FAQ
How are the miR Sentinel™ Prostate Cancer Test results received?

The report will be securely delivered to the provider who ordered the test, either via secure fax or our online provider portal through CareEvolve.

Where is the miR Sentinel™ Prostate Cancer Test commercially available?

The miR Sentinel™ Prostate Cancer Test is commercially available in most US states as well as Puerto Rico. The Test is not currently available in New York, California, Pennsylvania, Maryland, Rhode Island and Washington, D.C. We are working to bring miR Sentinel™ to all 50 U.S. states, all territories and global markets including Canada, Israel and Singapore.

How can I place a Collection Kit order?

miR Scientific Collection Kits can be ordered by a healthcare provider over the phone, by contacting miR Scientific’s customer service team at 1-855-55CALLMIR.

What are the payment options for the miR Sentinel™ Prostate Cancer Test?

miR Scientific is currently exploring insurance coverage and Medicare reimbursement with several carriers in the US and Puerto Rico but is currently an out-of-network provider. Patients will have the option of paying with credit card or we can assist with submitting out-of-network claims to their carrier. We plan to offer a patient assistance program called miR Access™ to support access to the test for those in need.

Is the miR Sentinel™ Prostate Cancer Test available in stores?

miR's Sentinel™ Prostate Cancer Test is currently only available through a health care provider. Please speak with your physician about possible testing options.

FAQ CENTER

Support

We're here to help! Visit our support center for FAQs and options to connect with a miR Sentinel expert directly.

SUPPORT CENTER