Louisville Bioscience, Inc. (LBIdx™) has made a significant breakthrough in the analysis of blood plasma using Differential Scanning Calorimetry for Clinical Monitoring and Diagnostic applications.
LBIdx™ is pursuing parallel development of their Plasma Thermogram™ (pT™) technology platform as Laboratory Developed Tests (LDTs) for the monitoring of Cancer and Autoimmune patients.
Cancer Monitoring & Screening
New minimally invasive tools are imperative for improved therapeutic monitoring and early detection of cancer remission and relapse. Current methods for cancer detection and monitoring include surgical biopsy, serological testing, ultrasound and imaging (X-ray, MRI, CT scan, PET). All have limitations and drawbacks for early detection of disease relapse. Most notably is the need for a non-invasive monitoring tool for high-risk patients. LBIdx™ clinical and commercial partners have stated a simple blood assay like the pT™, capable of discriminating between early stages and more advanced stages of carcinoma, will be highly beneficial.
LBIdx™’s first pT™ test will be for the monitoring of melanoma patients currently under treatment and/or being watched for remission or relapse during a 5-year window. The Melanoma pT™ will be released as a Laboratory Developed Test (LDT).
The cancer remission pT™ pipeline includes early, positive clinical results for ovarian, cervical and lung cancers.
Autoimmune Monitoring & Differentiation
According to the American Autoimmune and Related Diseases Association, “Approximately 50 million Americans, suffer from autoimmune diseases.” LBIdx’s™ Autoimmune Plasma Thermogram™ (pT™) test will be for the inflammatory monitoring and differentiation of five generally well-known autoimmune diseases which are often difficult to monitor, diagnose and differentiate: Lupus, Rheumatoid Arthritis, Multiple Sclerosis, Polymyositis and Scleroderma.
CLIA Lab Focus
LBIdx™ is establishing a CLIA lab to drive near-term adoption of the Plasma Thermogram™ (pT™) Laboratory Developed Tests (LDTs) and support ongoing clinical needs in this area.
The Plasma Thermogram™ (pT™)
Clinical Diagnostic & Life Science Applications
The Plasma Thermogram™ (pT™) assay is a robust physical test with high assay reproducibility. It is inexpensive, non-invasive, requires only a single drop of blood, and can be performed in less than an hour.
Measurement of plasma proteins is a powerful clinical tool for detecting, monitoring and diagnosing diseases and associated pathophysiological processes. Administration of numerous FDA-approved plasma/serum assays is standard medical practice and has profoundly impacted the world of medical diagnosis.