OPKO Health has patented a method for predicting prostate cancer in tissue biopsies by measuring levels of intact prostate specific antigen (iPSA) using a 4D4 antibody in an immunoassay. The method involves comparing levels to a set of standards for accurate diagnosis. GlobalData’s report on OPKO Health gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on OPKO Health, Peptide pharmacophores was a key innovation area identified from patents. OPKO Health's grant share as of February 2024 was 55%. Grant share is based on the ratio of number of grants to total number of patents.

Improved method for predicting prostate cancer using immunoassay

Source: United States Patent and Trademark Office (USPTO). Credit: OPKO Health Inc

A recently granted patent (Publication Number: US11921115B2) outlines a method for quantifying levels of a prostate antigen, specifically intact prostate specific antigen (iPSA), in a sample using an immunoassay. The method involves utilizing a tracer antibody, the 4D4 antibody, to measure the iPSA levels in the sample. The immunoassay includes contacting iPSA with a capture antibody specific for iPSA, producing a capture-antibody-iPSA complex, and detecting this complex bound to the 4D4 antibody. The patent specifies a set of prostate antigen standards with known levels of iPSA, ranging from 0.025 ng/mL to 15 ng/mL, to determine the quantity of the prostate antigen in the sample. The target population for this method is described as men with varying age ranges, from 55 to 75 years, with the median age falling between 60 to 70 years.

Additionally, the patent includes details about a prostate antigen detection kit designed for quantifying iPSA levels in a sample. The kit comprises the set of prostate antigen standards, the tracer antibody (4D4 antibody), a buffer with a specific pH range, and instructions for quantifying the levels of the prostate antigen. The method also allows for the determination of a second prostate antigen, human kallikrein 2 (hK2), in the sample using a similar immunoassay approach with specific antibodies and standards. The patent emphasizes the importance of the limit of quantification, ensuring accurate detection and quantification of the prostate antigens with a coefficient of variation of less than 25%. Overall, the patent provides a detailed and structured method for accurately measuring and quantifying levels of prostate antigens in samples, catering to different age groups within the male population.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies across the world’s largest industries.