OPKO Health has been granted a patent for improved methods of predicting the presence of prostate cancer in a tissue biopsy. The patent involves a method of determining kallikrein levels in a blood sample, using immunoassays to measure levels of specific antigens. A linear regression model is then used to determine the probability of detecting prostate cancer in a biopsy. A biopsy is indicated if the probability is 7.5% or higher. 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 September 2023 was 51%. Grant share is based on the ratio of number of grants to total number of patents.

Method for determining kallikrein levels in blood for prostate cancer detection

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

A recently granted patent (Publication Number: US11761962B2) describes a method for determining kallikrein levels in a blood sample. The method involves several steps, including measuring levels of total prostate specific antigen (tPSA), free prostate specific antigen (fPSA), intact prostate specific antigen (iPSA), and human kallikrein 2 (hK2) in the blood sample using immunoassays.

In step (i), a blood sample is obtained from a subject with a tPSA level of less than or equal to 25 ng/mL. This sample is then subjected to immunoassays to measure the levels of fPSA, iPSA, and hK2. The immunoassay for iPSA involves contacting iPSA in the blood sample with a capture antibody specific for iPSA and nicked PSA, and then combining the capture-antibody-iPSA complex with a tracer antibody that binds specifically to iPSA. The complex is then detected.

In step (iv), the blood sample is also subjected to an immunoassay to measure the level of hK2. This involves contacting PSA in the blood sample with PSA blocking antibodies, and then contacting hK2 with a capture antibody to produce a capture-antibody-hK2 complex. The complex is then detected using a second tracer antibody and a PSA blocking antibody.

Finally, in step (v), a linear regression model is used to determine the probability that a prostate tissue biopsy for the subject would contain any detectable prostate cancer or detectable high-grade prostate cancer. The model takes into account various factors such as age, tPSA, fPSA, iPSA, hK2, digital rectal examination results, and prior biopsy history.

The patent also includes additional claims related to the method, such as determining the probability of detecting high-grade prostate cancer with a Gleason score of greater than or equal to 7.0, using specific capture antibodies and tracers, and using blood plasma samples.

Overall, this patent describes a comprehensive method for determining kallikrein levels in a blood sample and using a linear regression model to assess the probability of detecting prostate cancer. This method has the potential to improve the accuracy of prostate cancer diagnosis and guide decisions regarding the need for a prostate tissue biopsy.

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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.