US2023274836A1PendingUtilityA1

Method of calculating diagnostic score for prostate cancer and use thereof

Assignee: UROTECH CO LTDPriority: Sep 8, 2020Filed: Feb 28, 2023Published: Aug 31, 2023
Est. expirySep 8, 2040(~14.1 yrs left)· nominal 20-yr term from priority
G16H 50/30G16H 50/20G16H 50/70G16H 40/63G16H 10/40G16B 15/30G16B 25/20G16H 10/60C12Q 1/6886C12Q 2600/178C12Q 1/68G16B 30/10C12Q 2563/107
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Claims

Abstract

The present specification provides a method of calculating a diagnostic score for prostate cancer by combining at least two values. The method comprises preparing a sample, obtaining a first value, obtaining a second value, and calculating a diagnostic score. The sample is a urine sample from a subject, and the first value corresponds to an amount of a hsa-miR-3659 or hsa-miR-3679-5p derived from extracellular vesicles in the sample, and the second value corresponds to a miRNA derived from the extracellular vesicles in the sample. Both the first and second values include information on whether the subject has developed prostate cancer, and the second value corresponds to a normalization factor specialized for the first value. The diagnostic score for prostate cancer calculated according to the method is characterized by being capable of diagnosing prostate cancer. The present specification provides a use of the diagnostic score for prostate cancer.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for identifying and treating prostate cancer in a subject, the method comprising:
 determining a first value related to the amount of a first target in a subject urinary sample,   wherein the first target is hsa-miR-3659 or hsa-miR-3679 derived from extracellular vesicles in the sample,   wherein the first value is informative of presence of prostate cancer of the subject and of noise caused by an endogenous factor that is independent from the presence of prostate cancer of the subject;   determining a second value related to the amount of a second target in the subject sample,   wherein the second target is a second miRNA derived from extracellular vesicles in the sample,   wherein the second value is informative of the presence of prostate cancer,   wherein the second value is related to the endogenous factor and is correlated with the noise caused by the endogenous factor;   comparing a ratio of the first value and the second value to a predetermined value,   thereby determining the presence of prostate cancer; and   if the comparing result indicates that prostate cancer is present in the subject, performing a biopsy on the subject.   
     
     
         2 . The method of  claim 1 , wherein the endogenous factor includes:
 a first condition related to the sample; and   a second condition related to the subject.   
     
     
         3 . The method of  claim 2 , wherein the first condition is at least one selected from an amount of the sample, a sample collection time, a method of collecting the sample, a sample storage duration, a sample storage temperature, and a method of dividing the sample. 
     
     
         4 . The method of  claim 2 , wherein the second condition is at least one selected from the gender of the subject, the age of the subject, the race of the subject, the bodyweight of the subject, the kidney function of the subject, the hydration state of the subject. 
     
     
         5 . The method of  claim 1 , wherein the determining the first value further comprises:
 synthesizing a first cDNA of the first target in the sample;   amplifying the first cDNA by polymerase chain reaction using a first primer,   wherein the first primer has a sequence selected from SEQ ID NOs. 1 to 2; and   determining the first value from a result of the amplifying of the first cDNA.   
     
     
         6 . The method of  claim 1 , wherein determining the second value further comprises:
 synthesizing a second cDNA of the second target in the sample;   amplifying the second cDNA by polymerase chain reaction using a second primer,   wherein the second primer has a sequence including a homologous sequence to the second target or a complementary sequence to the second target; and   determining the second value from a result of the amplifying of the second cDNA.   
     
     
         7 . The method of  claim 6 , wherein the second target is hsv2-miR-H9-5p or hsa-miR-1913, and wherein the second primer has a sequence selected from SEQ ID NO: 3 and SEQ ID NO: 5.

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