Llame al: 1-940-MIR-SENTINEL (1-940-647-7368)
miR Sentinel™
Prueba de Cáncer de Próstata
Más información

Por quémiR Sentinel

Detecta y clasifica el cáncer de próstata con precisión con la prueba miR Sentinel™: innovadora, sin dolor, completa, sencilla, realizada con una simple muestra de orina.

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

Un Método Molecular para la Detección y Clasificación del Cáncer de Próstata

La prueba miR Sentinel™ puede complementar valiosamente las herramientas actuales para la detección del cáncer de próstata, ofreciendo una estratificación dinámica del riesgo.

No Invasiva

La prueba miR Sentinel™ requiere solo una muestra de orina, sin contacto.

Accurate

Detects and risk-classifies prostate cancer with high sensitivity, giving patients and providers confidence in the information used to plan management and treatment.

Simple

A one-step non-DRE urine test that helps answer your two most important questions: Is there molecular evidence of prostate cancer? If so, how severe is the risk of aggressive disease.

Precisa

The first single test to detect the presence of molecular evidence of aggressive 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 molecular evidence of aggressive 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 presents No Molecular Evidence of Prostate Cancer.

Low-Risk

This result indicates that the patient presents Molecular Evidence of Low-Risk for Aggressive Prostate Cancer

Elevated Risk

This result indicates that the patient presents Molecular Evidence of Elevated-Risk for Aggressive Prostate Cancer

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
Cómo se recibe el resultado de la prueba miR Sentinel™?

El resultado será enviado de forma segura al médico que solicitó la prueba, ya sea mediante fax seguro o correo electrónico.

Dónde está disponible de forma comercial la prueba miR Sentinel™?

Estará disponible comercialmente en la mayoría de los estados de EE. UU. y en Puerto Rico a principios de 2025. Actualmente, no está disponible en Nueva York.

Cómo puedo solicitar un kit de recolección?

El kit de recolección de MiRNA Scientific puede ser solicitado por un proveedor de salud mediante vía telefónica, llamando a Servicio al Cliente: 1 (940) 647-7368.

Cuáles son las opciones de pago para la prueba miR Sentinel™?

MiRNA Scientific se encuentra trabajando con aseguradoras de salud y Medicare en EE. UU. y Puerto Rico, sin embargo, es posible que la prueba no esté cubierta. Presentaremos una reclamación por usted, y someteremos cualquier proceso apelativo, si aplica. De ser necesario, los pacientes pueden solicitar participación al programa de asistencia miR Access, y proceder con el pago de cualquier saldo restante mediante tarjeta de crédito.

La prueba miR Sentinel™ está disponible en establecimientos?

Actualmente, solo está disponible a través de un proveedor de salud. Hable con su médico sobre las opciones de prueba disponibles.

Support

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

SUPPORT CENTER