Hunan Provincial Cancer Hospital Licenses TSH Detection Technology for RMB 10 Million

Recently, the Translational Medicine Center of Hunan Cancer Hospital released a public notice on the transformation of scientific and technological achievements, proposing to transfer“Thyroid-Stimulating Hormone Detection Kit and Immunofluorescence Analyzer Technology”The relevant patent portfolio has been licensed to Hunan Medical Technology Co., Ltd. for use, with a total licensing fee of RMBRMB 10 million.

This technology transfer adopts a "royalty payment" model, under which the partner, Hunan Medical Technology Co., Ltd., will make installment payments to the hospital as agreed, reflecting a market-oriented cooperation mechanism characterized by shared risks and shared benefits. Meanwhile, in accordance with the Implementation Measures for Promoting the Transformation of Scientific and Technological Achievements of Hunan Cancer Hospital and related incentive policies, the achievement completion team—the Shi Feng team—will receive a cash reward of RMB 8 million, representing 80% of the total transfer amount.

The system proposed for translation in this instance is a supporting system designed for the rapid and accurate quantitative detection of thyroid-stimulating hormone (TSH), primarily comprising:

1. Integrated Dual-Chamber Sampling Dropper:Enables simultaneous and precise collection of peripheral blood samples and diluent, simplifying the procedure and ensuring accurate dilution ratios;

2. Thyroid-Stimulating Hormone (TSH) Test Strips:Quantitative testing can be completed within 15–20 minutes using capillary blood, eliminating the need for venous blood sampling and offering convenience and speed.

The combination of the two forms a complete solution from sampling to detection, which is particularly suitable for rapid clinical screening and routine monitoring, thereby improving detection efficiency and result reliability.

The thyroid gland is a vital endocrine organ in the human body, and the thyroid hormones it secretes regulate metabolism throughout the body.

Clinically, precise monitoring of thyroid-stimulating hormone (TSH) levels is essential for guiding the diagnosis and treatment of various thyroid disorders, including hypothyroidism, hyperthyroidism, thyroiditis, thyroid nodules, and thyroid cancer. TSH, a hormone secreted by the pituitary gland, serves as a core indicator for assessing the function of the hypothalamic-pituitary-thyroid axis, as its level changes sensitively reflect subtle abnormalities in thyroid function.

For example, patients with hypothyroidism require lifelong levothyroxine therapy and regular TSH monitoring to adjust dosage; during the treatment of hyperthyroidism, clinical decisions are also guided by TSH and thyroid hormone levels; similarly, postoperative management of thyroid cancer relies on TSH monitoring to formulate TSH suppression therapy strategies.

Currently, mainstream clinical TSH testing relies onVenous blood samples were collected at the hospital and analyzed using chemiluminescent immunoassay.Although this method offers high accuracy, it has significant drawbacks.

The entire process requires patients to make a special trip to the hospital to register, wait in line, and undergo venipuncture for blood collection by professional medical staff. This is not only time-consuming and labor-intensive but also causes inconvenience and psychological burden to patients. The collected blood samples must be sent to the clinical laboratory for a series of processing steps and instrumental analysis. Patients typically need to wait several hours or even longer to obtain their test reports.

This model fails to meet the urgent need for convenient and rapid testing among patients requiring frequent monitoring, such as pregnant women and postoperative patients.

Furthermore, although some testing technologies have adopted capillary blood from fingertip pricks as a substitute for venous blood, thereby simplifying the blood collection process, challenges remain in practical testing operations. Many testing methods require precise dilution of blood samples, and the accuracy of the dilution ratio directly affects the reliability of the final test results.

This critical step typically relies on professional laboratory personnel using traditional single-channel pipettes, a cumbersome process that is inefficient when switching between different liquids (such as blood and diluents), prone to introducing errors, and thus limits its widespread adoption in non-professional settings (e.g., homes and communities).

Therefore, existing technologies suffer from drawbacks in practical applications, including cumbersome workflows, long waiting times, high requirements for specialized operation, and difficulty in balancing immediacy with accuracy.

It is precisely the numerous inconveniences and limitations inherent in current clinical testing—including reliance on venous blood collection, prolonged turnaround times for reports, complex sample pre-processing workflows, and stringent requirements for specialized operation—that have driven the development of next-generation testing technologies.

The integrated solution provided by this patent portfolio offers core advantages and advanced features by fundamentally revolutionizing the traditional model of thyroid-stimulating hormone (TSH) testing, through“Precision Sampling” and “Rapid Quantitative Detection”The seamless synergy of the two technologies establishes a complete, convenient, and reliable diagnostic closed loop.

This protocol first revolutionizes the sample collection process.

Conventional testing relies on venous blood sampling, with samples undergoing precise dilution by professionals in a laboratory setting. This process is complex and difficult to replicate in home or community settings. The utility model provided hereinDual-Chamber Sampling Dropper, through its originalIntegrated Dual-Lumen, Dual-Balloon Design, ingeniously resolving this challenge.

This dropper featuresIndependentSample Aspiration ChamberandDiluent Aspiration Chamber, respectively connected to an elastically contractile fluid reservoir.

Users can easily collect fingertip capillary blood and draw a quantitative amount of diluent by sequentially or simultaneously squeezing and releasing the reservoir bulb. Most critically, precise graduations are marked on the outer walls of both lumens, enabling users to intuitively and accurately control the volumes of aspirated blood and diluent, thereby ensuring the high accuracy of the dilution ratio required for subsequent testing.

This design simplifies the specialized dilution procedures, originally requiring a laboratory setting, into a straightforward, one-step manual operation. It significantly lowers the operational threshold and reduces reliance on technical expertise, marking a crucial first step toward high-quality testing.

Following precise sampling and dilution, another core component of this protocol—Thyroid-Stimulating Hormone (TSH) Test Stripbegins to play a key role. This test strip utilizes advancedFluorescent Microsphere Immunochromatography Technology, its detection principle isTSH antibodies labeled with fluorescent microspheres are pre-coated on a specific area (antibody pad) of the test strip.

When the test sample (i.e., diluted capillary blood) is applied to the test strip, it flows forward along the chromatographic membrane. The TSH antigen in the sample first binds to these fluorescently labeled antibodies, forming a complex.

This complex continues to migrate to the test line (T line), where it is captured and concentrated by a second TSH antibody immobilized at that location, forming a fluorescent signal band readable by an instrument. The intensity of the fluorescent signal is proportional to the concentration of TSH in the sample. A control line (C line) is also provided on the test strip to ensure the validity of each test procedure.

The advancement of this method lies in the fact that it usesFluorescent MicrospheresIt is a polymeric nanoparticle containing rare earth elements. Each microsphere can carry tens of thousands of fluorescent molecules, functioning as a high-brightness “signal amplifier.” Therefore, even when the TSH concentration in blood samples is very low, it can be sensitively detected and generate strong fluorescent signals, thereby enabling high-precision quantitative analysis of trace peripheral blood samples. Its detection sensitivity and accuracy have been experimentally verified to be highly consistent with the results obtained from large-scale chemiluminescence instruments used in hospitals.

In summary, the advancement of this patent portfolio lies not in the improvement of a single device, but in a systematic innovation. It transforms sample pre-processing (precise dilution), which previously required professional operation, into simple steps that can be independently performed by users. Meanwhile, it innovates laboratory testing (TSH quantification), which traditionally relied on large instruments and entailed long waiting times, into rapid, quantitative readouts based on cutting-edge immunochromatographic technology.

The combination of the two enablesWithin 15 to 20 minutes，Using Only a Single Drop of Capillary Blood, making it possible to obtain professional-grade quantitative TSH results comparable to venous blood testing.

This not only significantly improves testing efficiency and alleviates the burden on medical institutions, but more importantly, provides patients with thyroid diseases—particularly those with hypothyroidism, hyperthyroidism, and postoperative patients requiring frequent monitoring—with unprecedented, convenient, and reliable home-based monitoring capabilities, truly achieving a paradigm shift from “hospital-centric testing” to “patient-proximate monitoring.”

Currently, for the vast markets of endocrine metabolism, cardiovascular diseases, and early tumor screening, which also rely on blood marker monitoring and have a huge demand for "point-of-care testing," the R&D team and related companies have begun to lay out the next generation of pipelines under research.

Wantai BioHand in HandNational Engineering Research Center for Diagnostic Reagents and Vaccines for Infectious Diseases, Xiamen University(NIDVD), with innovation at its core, has deeply cultivated the field of precision diagnosis and treatment for thyroid diseases. By breaking through the core technological barriers of thyroid function test reagents, it has launched a new generation of thyroid function testing solutions, which can provide efficient and precise clinical support for thyroid disease screening, diagnosis, and treatment monitoring.

Meanwhile, this TSH assay reagent, together with assay reagents for total triiodothyronine (TT3), total thyroxine (TT4), free triiodothyronine (FT3), and free thyroxine (FT4), as well as assay reagents for thyroid peroxidase antibody (TPOAb), thyroglobulin antibody (TgAb), and thyrotropin receptor antibody (TRAb), and the calcitonin (CT) assay reagent, collectively constitute the “Wantai Chemiluminescent Thyroid Function 10-Panel” solution for thyroid disease management. The related achievements are supported by product instructions for use and clinical evaluation reports. As a mature technology and product portfolio already launched to provide clinical support, it facilitates precise diagnosis and treatment of thyroid diseases and tumor marker detection.

Shenzhen Lifotronic Technology Co., Ltd.In the field of thyroid function testing, we have launched a Free Thyroxine (FT4) Assay Kit (Electrochemiluminescence Method). As the company’s next-generation product, it employs a double-antibody sandwich electrochemiluminescence method to detect FT4 (free thyroxine), which is closely associated with the assessment of thyroid function and aids in the diagnosis of hypothyroidism or hyperthyroidism. This assay effectively enhances the sensitivity, precision, and specificity of the reagent. The product has obtained market access approval in China and is a mature offering that has completed registration and is ready for commercial promotion.

Hotgen BiotechIn the field of supporting systems for rapid and accurate quantitative detection of thyroid-stimulating hormone (TSH), significant achievements were made in September 2025, with the newly obtained medical device registration certificate for the TSH Assay Kit (Magnetic Particle Chemiluminescence Immunoassay) issued by the Hebei Provincial Medical Products Administration. This kit belongs to the company’s series of small-molecule sandwich assay reagents for thyroid function, marking the official approval and market launch of the related products.

This TSH assay kit overcomes the technical bottlenecks of traditional competitive methods for detecting small-molecule hormones. In terms of compatible testing efficiency, the kit is designed to work with Hotgen Biotech’s C-series fully automated chemiluminescence immunoassay analyzers. It requires no complex sample pretreatment and supports direct loading from primary tubes, delivering results in just 18 minutes. This fully automated process minimizes manual errors and enhances efficiency, making it suitable for applications such as neonatal thyroid function screening, diagnosis of subclinical thyroid disorders, and monitoring of patients with severe hyperthyroidism.

The TSH assay kit and its accompanying small-molecule sandwich immunoassay system for thyroid function testing have completed domestic market access in China and are currently in the commercial launch phase. They provide “rapid and accurate” thyroid function testing support for clinical practice, facilitating precise diagnosis and treatment of thyroid diseases.

In summary, by integrating precise sampling with rapid quantitative detection, this technical solution offers a new approach to resolving the trade-off between convenience and accuracy in thyroid function testing.