Zhejiang University to Transfer Five Patents for Systemic Inflammation and Sepsis Diagnostic Technologies for RMB 4 Million

Recently, Zhejiang University released a public notice on the transformation of scientific and technological achievements, proposing to transfer via agreement-based pricing.Five Biomarkers for Systemic Inflammation Diagnosis and Related Patents on Their ApplicationsTransfer, with a transfer fee of“RMB 1 million upfront payment” + “RMB 3 million milestone payments,” totaling RMB 4 million. The inventor of this patent is Sir Run Run Shaw Hospital, Zhejiang University School of MedicineMa Yilei and His Team。

There are significant differences in biomarker levels between samples from patients with systemic inflammation and those from healthy individuals. Clinical validation has demonstrated that the use of this biomarker for diagnosis exhibits high sensitivity and specificity. The team has developed a biomarker for diagnosing systemic inflammation and its applications, which includes ADGRE3 mRNA and protein fragments such as ADGRE3. By detecting the transcriptional level of ADGRE3 mRNA or the expression level of ADGRE3 protein in individual samples, systemic inflammation can be accurately diagnosed.

Compared with existing inflammatory markers, ADGRE3 mRNA and ADGRE3 protein demonstrate higher sensitivity and specificity in the diagnosis of systemic inflammation.

The clinical diagnosis of systemic inflammation and related conditions such as sepsis has long faced core challenges, including poor specificity, difficulty in distinguishing types of infection, and delayed prognostic assessment. Traditional inflammatory markers (such as CRP, PCT, and IL-6) cannot effectively differentiate between local and systemic inflammation and are susceptible to interference from non-inflammatory factors, leading to high misdiagnosis rates. Furthermore, these markers exhibit low sensitivity in cases of viral infections and asymptomatic infections, making early and precise identification difficult and thereby delaying timely treatment.

In terms of diagnostic efficacy, existing indicators have many limitations. On the one hand, poor specificity makes clinical differentiation quite difficult. The levels of traditional biomarkers do not differ significantly among healthy individuals, patients with local inflammation, and those with systemic inflammation, making it challenging to rule out interference from local inflammation. Preliminary diagnosis usually requires combining imaging examinations, which undoubtedly increases medical costs and extends the diagnostic cycle.

On the other hand, its ability to differentiate types of infection is limited, making it difficult to accurately distinguish systemic inflammation caused by different pathogens such as bacteria and viruses. It also fails to effectively differentiate sepsis from non-infectious systemic inflammatory response syndrome (e.g., trauma, severe acute pancreatitis), resulting in a lack of targeted treatment strategies.

Furthermore, existing indicators have limited capacity for early warning of progression to critical illness and adverse outcomes, making it difficult to dynamically reflect the evolution of sepsis patients' conditions. Consequently, they fail to provide timely guidance for adjustments in clinical treatment, particularly exhibiting shortcomings in the identification of high-risk patients.

For special populations and conditions, diagnostic pain points are more pronounced. Existing biomarkers struggle to effectively identify and accurately classify groups such as asymptomatic COVID-19 carriers and patients with non-infectious systemic inflammation. Furthermore, the severity stratification of sepsis (e.g., distinguishing between general sepsis and septic shock) lacks support from highly specific biomarkers, which adversely affects clinical decision-making and the rational allocation of medical resources.

These issues have led to clinical diagnosis falling into“High Risk of Missed and Misdiagnosis” and “Insufficient Treatment Specificity”the dual dilemma. Therefore, there is an urgent need for a novel diagnostic approach that combines high sensitivity, strong specificity, and adaptability across multiple scenarios to overcome the core bottleneck in the precise diagnosis of systemic inflammation.

This patent, withADGRE3-Related BiomarkersCentered on this core, it has broken through the limitations of traditional technologies across multiple dimensions—including diagnostic efficacy, scenario adaptability, and clinical application—thereby establishing a more precise and comprehensive systemic inflammation diagnostic system with significant core advantages.

In terms of diagnostic accuracy,ADGRE3 mRNA and protein levels exhibit a markedly significant downward trend in the peripheral blood of patients with systemic inflammation, showing highly significant differences compared to healthy individuals and patients with localized inflammation. Its diagnostic sensitivity and specificity are superior to those of traditional markers such as C-reactive protein (CRP) and procalcitonin (PCT). This biomarker can effectively exclude interference from localized inflammation and, when used alone, can accurately distinguish between systemic and non-systemic inflammation, substantially reducing the risk of misdiagnosis and missed diagnosis.

In terms of scenario adaptability coverage,In patients with systemic inflammation, ADGRE3 can help differentiate bacterial infections from viral infections, and further distinguish between Gram-positive bacterial infections and H1N1 infections, asymptomatic COVID-19 infections and symptomatic COVID-19 infections, as well as acute RSV infection and the convalescent phase.

For patients with sepsis, dynamic monitoring of ADGRE3 levels can be used to assess the severity of inflammation and treatment response, thereby aiding in the evaluation of disease progression trends.

In terms of clinical accessibility,This technology is characterized by its ease of operation and strong compatibility. It primarily utilizes peripheral blood as the detection sample, eliminating the need for specialized sampling procedures. For ADGRE3 mRNA, transcriptional levels can be assessed using qRT-PCR; for protein expression, immunological methods such as flow cytometry or ELISA can be employed. All these assays can be performed using existing clinical equipment.

Meanwhile, this biomarker can be used in combination with traditional bacterial inflammation markers such as procalcitonin (PCT) to further improve the accuracy of differentiating infection types, providing flexible diagnostic solutions for clinical practice and facilitating rapid adoption.

Currently, the market for systemic inflammation diagnostics is dominated by traditional inflammatory marker testing products, while a small number of novel biomarker technologies are entering the translational phase, overall presenting“Traditional Products Dominate the Mainstream, Innovative Technologies Address Shortcomings”landscape.

Acon Biotech (Hangzhou) Co., Ltd.LaunchedFlowflex® Full-Range C-Reactive Protein/Serum Amyloid A Test Reagent,Utilizing fluorescent immunochromatography, this method enables the simultaneous detection of two classic inflammatory markers, CRP and SAA. Results are available within 5 minutes, and it supports various sample types, including serum, plasma, and whole blood, making it widely applicable for initial clinical inflammation screening.

BRAHMS AG, GermanyR&DPCT-Kryptor® Procalcitonin Assay Kit,Based on time-resolved fluorescence immunoassay technology, this FDA-approved automated sepsis testing product evaluates the risk of bacterial infection and the severity of sepsis by measuring procalcitonin (PCT) concentrations. PCT test results are positively correlated with the severity of infection, and the product is widely used in intensive care settings.

Peking University HospitalR&DmCRP Marker Detection Kit,Using modified C-reactive protein as the core biomarker, focusing on early identification and risk assessment of renal inflammatory diseases, has beenRMB 10 millionTransferred to Beijing Dian Medical Laboratory Co., Ltd.