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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
La prueba miR Sentinel™ puede complementar valiosamente las herramientas actuales para la detección del cáncer de próstata, ofreciendo una estratificación dinámica del riesgo.
Inaccurate
Invasive
Painful
Expensive
Dangerous
Wasteful
A diferencia de otras pruebas de sangre u orina disponibles, la prueba miR Sentinel™ analiza toda la próstata, lo que permite obtener resultados más precisos. Si hay evidencia molecular de cáncer agresivo, los resultados clasifican la condición del paciente en categorías que describen el riesgo del tumor.
La próstata libera naturalmente moléculas en la orina, incluyendo distintos tipos de material genético que varían según la presencia y gravedad del cáncer de próstata. Extraemos y medimos fragmentos conocidos como pequeños ARN no codificantes (sncRNA) mediante tecnología de expresión génica y un algoritmo de evaluación. La prueba miR Sentinel™ no es dependiente de imágenes, PSA, ni material de biopsia.
El paciente no presenta evidencia molecular de cáncer de próstata.
El paciente presenta evidencia molecular de bajo riesgo para cáncer de próstata agresivo.
El paciente presenta evidencia molecular de riesgo elevado para cáncer de próstata agresivo.
All in all, the current standard of care is invasive, inaccurate, expensive, overly complicated due to the multitude of steps required for proper diagnosis.
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Más informaciónEl resultado será enviado de forma segura al médico que solicitó la prueba, ya sea mediante fax seguro o correo electrónico.
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.
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.
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.
Actualmente, solo está disponible a través de un proveedor de salud. Hable con su médico sobre las opciones de prueba disponibles.
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