Advancements in Computational Digital Pathology for EGFR and pd-l1


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Annually Inova Health Care System treats more than two million individuals through their integrated network. With the increasing need for fast and accurate results for its cancer patients, the Inova Laboratories Healthcare System’s reference laboratory, has acquired a Rapid Molecular Testing System, called BioCartis Idyllatm which is a real-time PCR bases molecular testing system. This system is user friendly and will help improve the turnaround time for diagnosis and treatment of cancer patients. Most of the existing molecular testing for Next-Generation Sequencing (NGS) platforms such as whole genome sequencing, Exon sequencing and Disease diagnosis panel takes approximately fourteen days or longer to obtain results. This is due to the need for high volume batched samples, specimen procurement, transportation and complex interpretation. While there have been great expansion of knowledge on molecular changes occurring in the cancer development, clinical utility of molecular tests for the diagnosis and especially for the treatment of cancers have been limited. The FDA has approved some treatments targeted for specific molecular changes such as EGFR mutation and KRAS mutation in lung cancers and BRAF mutation in melanomas. Molecular testing aids the pathologist to check for certain changes in a gene or chromosome that may cause or affect the chance of developing a specific disease or disorder, in this case lung cancer. Another area of rapid progress is the advancement of immune targeted therapy aimed at PD-L1. Initially applied to lung cancers and some GI cancers, and has been approved by FDA- for multiple cancer types recently. To be able to apply these advanced therapeutics there is a growing need for more efficient targeted biomarker testing, including fast TAT (turnaround time), user friendliness, remarkable accuracy, specificity and sensitivity which are equivalent to the NGS test results The objective of this project is to determine the use of rapid molecular tests for tumor mutations and the application of AI-based digital scoring methods of IHC (immunohistochemistry) test for PD-L1 for Keytruda® (Pembrolizumab).