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WO-2026096699-A2 - BIOSENSORS FOR HORMONE MEASUREMENT

WO2026096699A2WO 2026096699 A2WO2026096699 A2WO 2026096699A2WO-2026096699-A2

Abstract

A biosensor for detecting a hormone is provided. The biosensor for detecting a hormone can include a core component and a biological molecule (such as a receptor for the hormone or an antibody against the hormone) immobilized on the biosensor. Also provided are methods for detecting or quantitating a hormone in a sample using the biosensor provided herein. The biosensor can be a bio-layer interferometry (BLI) biosensor, and the signals generated by binding of a hormone to the biosensor can be indicative of spectral shift, which can be measured using BLI. Additional signals such as UV absorbance of the hormone or signals of a detectable label may be measured. The biosensor can detect the presence or amount of the hormone in a sample accurately without interference by the presence of biotin, hemolysis, or lipid in a sample.

Inventors

  • BHARILL, Shashank

Assignees

  • SARTORIUS BIOANALYTICAL INSTRUMENTS, INC.

Dates

Publication Date
20260507
Application Date
20251030
Priority Date
20241030

Claims (15)

  1. 1. A method of detecting the presence or amount of a hormone in a sample, the method comprising: contacting the sample with a biosensor, the biosensor comprising a core component and a biological molecule immobilized thereon such that the hormone in the sample binds to the biological molecule, wherein the biological molecule is a receptor for the hormone or an antibody against the hormone; and detecting optical signals generated by binding of the hormone to the biosensor thereby detecting the presence or amount of the hormone in the sample.
  2. 2. The method of claim 1, wherein the signals are indicative of spectral shift measured using bio-layer interferometry (BLI).
  3. 3. The method of claim 2, wherein a positive spectral shift indicates binding of the hormone to the biosensor.
  4. 4. The method of claim 1, further comprising: detecting UV absorbance of the hormone bound to the biosensor.
  5. 5. The method of claim 1, further comprising: contacting the biosensor-bound hormone with a targeting molecule attached to a detectable label after contacting the sample with the biosensor such that the targeting molecule binds the biosensor-bound hormone; and 34 WBD (US) 4936-9869-2469vl Patent Application BA2408-WO S116321 1090WO (116321.00030) detecting signals of the detectable label attached to the targeting molecule bound to the biosensor-bound hormone.
  6. 6. The method of claim 5, wherein the detectable label is a fluorescent label.
  7. 7. The method of claim 5, wherein the detectable label is a horseradish peroxidase (HRP) label, and the method further comprises contacting the HRP-labeled targeting molecule bound to the biosensor with an HRP substrate to generate the signals of the detectable label.
  8. 8. The method of claim 1, wherein the hormone is a steroid hormone.
  9. 9. The method of claim 8, wherein the steroid hormone is progesterone or estradiol.
  10. 10. The method of claim 1, wherein the optical signals comprise light reflected from an interface internal to the biosensor and light reflected from an end of the biosensor.
  11. 11. A biosensor for detecting the presence or amount of a hormone in a sample, the biosensor comprising: a core component; and a biological molecule immobilized on the core component, wherein the biological molecule is a receptor for the hormone or an antibody against the hormone, and wherein the biosensor is configured to detect optical signals generated by binding of the hormone to the biosensor thereby to detect the presence or amount of the hormone in the sample. 35 WBD (US) 4936-9869-2469vl Patent Application BA2408-WO S116321 1090WO (116321.00030)
  12. 12. The biosensor of claim 11, wherein the biosensor is a bio-layer interferometry (BLT) biosensor.
  13. 13. The biosensor of claim 11, wherein the hormone is a steroid hormone.
  14. 14. The biosensor of claim 13, wherein the steroid hormone is progesterone or estradiol.
  15. 15. The biosensor of claim 11, wherein the optical signals comprise light reflected from an interface internal to the biosensor and light reflected from an end of the biosensor. 36 WBD (US) 4936-9869-2469vl

Description

Patent Application BA2408-WO S116321 1090WO (116321.00030) BIOSENSORS FOR HORMONE MEASUREMENT Background [0001] The present disclosure relates to apparatus and methods for detecting and/or quantitating a hormone in a sample. [0002] Measurement of hormones such as progesterone and estradiol provides important information regarding the subject’s health status that can be used for monitoring health (including pregnancy) or diagnosis, treatment, or prevention of a variety of diseases or conditions. However, accurate and efficient measurement of hormones in samples (such as blood, plasma, serum, or urine samples) is often challenging. Competitive immunoassays are commonly used in laboratories to measure hormone levels in biological samples. Because biotinylated antibodies competes with nanoprobes to bind to an analyte (e.g., a hormone), these immunoassays are sensitive to biotin in the samples, which often impacts the accuracy of the assays. Given that the majority of patients (reportedly about 64% of women) take dietary supplement/multivitamin that contains high levels of biotin, hormone measurements in biological samples using competitive immunoassays are often inaccurate. To improve accuracy, patients are usually requested to abstain from taking dietary supplements at least 3 days prior to the hormone measurement, making these time sensitive tests difficult to take and unsuitable for immediate testing. In addition, competitive immunoassays are sensitive to hemolysis and lipemia, rendering the hormone measurement inaccurate. [0003] Other assays for hormone measurements also have limitations. For example, electrochemiluminescence immunoassay (ECLIA) is also rendered inaccurate by the presence of biotin, hemolysis, or lipemia in the sample. Liquid chromatography-tandem mass spectrometry WBD (US) 4936-9869-2469vl Patent Application BA2408-WO S116321 1090WO (116321.00030) (LC/MS-MS) is time consuming, with turnaround time of about 8-12 days. Lateral flow assay/test only provides qualitative results without accurate measurement. Summary [0004] In view of the foregoing, there is a need for methods that efficiently, accurately, and rapidly detect the presence or amount of a hormone (such as a steroid hormone, such as progesterone or estradiol), including methods for efficient, accurate, and rapid hormone testing for pharmaceutical quality control. This disclosure is directed generally to systems and methods to address these shortcomings of the art and provide other additional or alternative advantages. The disclosure herein provides embodiments of biosensors, and methods using the biosensors, for detecting a hormone (such as a steroid hormone, e.g., progesterone and estradiol). The biosensor for detecting a hormone includes a core component and a receptor for the hormone or an antibody against the hormone immobilized on the core component. The biosensor can be a bio-layer interferometry (BLI) biosensor, and the optical signals generated by binding of a hormone to the biosensor can be indicative of spectral shift, which can be measured using BLI. The systems and methods provided herein can provide in vitro diagnostics, by providing tests on biological samples taken from the human body and detecting diseases or other conditions, monitoring the subject’s overall health to help cure, treat, or prevent diseases, and identifying patients who are likely to benefit from specific treatments or therapies. [0005] In certain aspects of the present disclosure, a method for detecting the presence or amount of a hormone in a sample is provided. The method includes contacting the sample with a biosensor, and detecting optical signals generated by binding of the hormone to the biosensor, thereby detecting the presence or amount of a hormone. The biosensor includes a core component and a biological molecule, which is a receptor for the hormone or an antibody against the hormone, 2 WBD (US) 4936-9869-2469vl Patent Application BA2408-WO S116321 1090WO (116321.00030) immobilized on the biosensor (e.g., the core component) such that the hormone in the sample binds to the hormone receptor/antibody of the biosensor. [0006] In embodiments, contacting the sample with the biosensor includes contacting the sample with a biosensor having a biotinylated hormone receptor/antibody bound to streptavidin bound to the biosensor (e.g., streptavidin-coated biosensor). The biotinylated hormone receptor/antibody is immobilized on the biosensor via streptavidin-biotin interaction. [0007] In embodiments, contacting the sample with the biosensor includes contacting the sample with a biosensor having the hormone receptor/antibody bound to the biosensor via then- terminus of the hormone receptor/antibody. The hormone receptor/antibody is immobilized on the biosensor via standard N-(3-(dimethylamino)propyl)-N’ -ethylcarbodiimide (EDC)-catalyzed amide bond formation to create a covalent bond between a reactive amine on the hormone receptor/antibody and the