PIF Binding Analysis for Immune Dysregulation Diagnosis
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Solution Overview
Problem
Current diagnostic methods for recurrent pregnancy loss (RPL) and endometriosis lack reliable biomarkers, leading to delayed diagnosis and ineffective treatment due to the invasive nature of existing methods and the absence of laboratory markers.
Innovation Solution
A method involving the analysis of PIF binding to immune cells, where PIF or its fragments are exposed to samples from subjects to assess binding affinity, using solid supports like chips or columns, and quantifying immune cell interactions via flow cytometry to identify immune dysregulation associated with RPL or endometriosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If laparoscopy is used as the gold standard for endometriosis diagnosis, then diagnostic accuracy is improved, but patient invasiveness and diagnostic latency increase
Solution Approach 1:
The patent introduces PIF binding analysis as an intermediary diagnostic method between non-invasive blood sampling and invasive laparoscopy. By measuring PIF binding to immune cells in blood samples, the patent provides a diagnostic tool that reflects endometriosis-related immune dysregulation without requiring surgical intervention, thus reducing patient invasiveness while maintaining diagnostic relevance
Solution Approach 2:
The patent enables preliminary diagnosis of endometriosis through PIF binding analysis before definitive laparoscopic confirmation is performed. By identifying immune dysregulation patterns in blood samples, clinicians can prioritize cases for surgical diagnosis and reduce unnecessary invasive procedures, thereby reducing overall patient invasiveness in the diagnostic process
2Reliability
If laparoscopy is used for definitive endometriosis diagnosis, then diagnostic reliability is improved, but diagnostic latency increases
Solution Approach 1:
The patent performs preliminary screening for endometriosis-related immune dysregulation using PIF binding analysis on blood samples before definitive laparoscopic diagnosis. This preliminary action identifies high-risk patients who would benefit from timely surgical confirmation, reducing the overall diagnostic latency by prioritizing cases that need invasive confirmation
Solution Approach 2:
The patent establishes a feedback mechanism where PIF binding patterns provide information about immune dysregulation status, allowing clinicians to adjust diagnostic timing and prioritize cases. Patients with abnormal PIF binding profiles can be expedited to laparoscopic diagnosis, reducing their diagnostic latency while maintaining overall diagnostic reliability
3Device complexity
If no laboratory biomarker is available for endometriosis, then diagnostic simplicity is maintained, but diagnostic capability deteriorates
Solution Approach 1:
The patent introduces PIF binding analysis as a laboratory biomarker intermediary that bridges the gap between simple blood sampling and complex surgical diagnosis. By measuring PIF binding to immune cells, the patent creates a quantifiable laboratory test that provides diagnostic information about endometriosis-related immune dysregulation without requiring surgical intervention
Solution Approach 2:
The patent replaces the mechanical/surgical approach of laparoscopy with a biochemical assay approach. By using PIF binding analysis to detect immune dysregulation patterns in blood samples, the patent substitutes a laboratory-based biochemical method for the mechanical surgical procedure, maintaining diagnostic capability while reducing invasiveness
4Loss of time
If traditional diagnostic methods are used for RPL, then treatment initiation is delayed, but treatment effectiveness may be improved through thorough evaluation
Solution Approach 1:
The patent performs preliminary identification of immune dysregulation in RPL patients using PIF binding analysis before initiating treatment. By detecting abnormal PIF binding patterns that indicate immune-mediated pregnancy loss, clinicians can start targeted immunomodulatory treatments sooner rather than waiting for exhaustive traditional workups, reducing treatment initiation time while maintaining treatment reliability through targeted therapy
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach allows for the early identification of immune dysregulation in subjects, potentially leading to timely and targeted treatment for RPL and endometriosis by quantifying significant changes in PIF binding to specific immune cells, thereby improving diagnostic accuracy and patient outcomes.
Implementation Method 1
The embryo-derived factor preimplantation factor (PIF-1) may cause immune tolerance of pregnancy by creating maternal recognition of pregnancy shortly after fertilization
Data Source
AI summary
Embodiments are directed to methods of examining preimplantation factor (PIF) binding to a subject's circulating immune cells as a marker for immune dysregulation. Some embodiments are directed to methods of detecting a level of immune dysregulation sufficient to cause recurrent pregnancy loss (RPL), methods of detecting a level of immune dysfunction sufficient to cause endometriosis, and methods of detecting a level of immune dysfunction comprising administering an effective amount of PIF or an analog thereof, and examining its binding to circulating immune cells. Within those methods, an about twenty percent change in PIF binding to a subject's circulating immune cells indicates a level of immune dysfunction.