The Puerto Rico Health Insurance Administration (ASES) has signed an agreement with miR Scientific to evaluate the economic and health benefits of using the miR Sentinel PCC4 Assay, also called the miR Sentinel Prostate Test, to alleviate the burden of prostate cancer in the U.S. territory.
Prostate cancer is the most common form of cancer and the most common cause of cancer death among men in Puerto Rico, prompting ASES to consider new ways of combatting the disease.
“The prevalence and economic burden of prostate cancer in Puerto Rico are debilitating and the Puerto Rico government is keen on deploying the most innovative solutions in the fight against prostate cancer,” Jorge Galva, executive director of ASES, said in a press release.
Current methods of prostate cancer detection rely on blood tests, which screen for the protein prostate-specific antigen (PSA), or on digital rectal exams. Following these initial tests, an invasive process — a biopsy of the prostate — is often taken to confirm the diagnosis.
The miR Sentinel Prostate Test is an investigative, non-invasive technique reported to be able to not only detect prostate cancer, but also to classify the severity of the tumor.
This is done by collecting a urine sample from the patient, the contents of which are subsequently analyzed in a laboratory. Urine contains structures called exosomes, which are small, membrane-bound vesicles that cells use to release various biomolecules like DNA, proteins, and RNA.
Among these molecules are small non-coding RNAs (sncRNAs), short strands of RNA that function to regulate gene expression in cells. Using computer algorithms, miR is able to analyze the sncRNA content in urinary exosomes to evaluate prostate cancer.
This analysis delivers results that include a Yes/No diagnosis of prostate cancer, as well as an assessment of high, intermediate, low, or no risk. According to miR, the high level of sensitivity offered by the Sentinel test has led to an 80% reduction in unnecessary biopsies.
The Sentinel test, also referred to as a liquid biopsy, is currently being evaluated in an observational clinical trial (NCT04100811), in which 2,000 participants undergoing a biopsy procedure for suspected prostate cancer will also submit urine samples to be analyzed by the test. Researchers will compare the biopsy results, as well as PSA blood test results, to the Sentinel results to determine the test’s efficacy.
The miR Sentinel Prostate Test has been designated a breakthrough therapy by the U.S. Food and Drug Administration (FDA). Should trial results be positive, miR expects the test to be commercially available in the U.S. in early 2021, and in select European and Asian markets in late 2021.
“The breakthrough Sentinel PCC4 Assay developed by miR Scientific is non-invasive and can very accurately detect prostate cancer and as well as classify the risk category of the disease based only on a single urine specimen and without the need for invasive biopsies,” Galva said. “This will allow us to manage the disease much better, allocate resources more efficiently, and focus on high-risk patients who are in need of definitive treatment quickly.”
In Puerto Rico, ASES agreed to evaluate the test’s economic and commercial utility, and will allow San Juan Bautista School of Medicine to appoint a principal investigator for this evaluation.
“We are fortunate and proud to commit to the long-term success of Puerto Rico’s emergence as a center of excellence for population health,” said Sam Salman, chairman and CEO of miR. “We are confident that our proactive and multifaceted collaborations in Puerto Rico will measurably improve outcomes in the war against cancer, and in doing so, contribute to the emergence of Puerto Rico as a leading center for medical innovation.”
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