However, ctDNA testing is known to sometimes give false-negative results (meaning the mutation is present but not detected by the ctDNA testing). For this reason, the FDA recommends a tissue biopsy if the liquid biopsy is negative (doesn’t detect a sensitizing mutation). In addition, a ...
In this group, which did test positive for T790M by tissue, the ORR was 64% and the median PFS was 15.2 months. “When we studied the tumor results on patients who were T790M-negative in the blood we could differentiate those who do better or worse on osimertinib, meaning that a biopsy...
To determine if our recommendation approach produces meaningful results we adopted a hybrid validation strategy. Recommendations were initially evaluated by domain experts, followed by targeted experimental validation of a few promising genes. The in silico evaluation demonstrated that majority (86%) of su...
Results Of the 143 patients evaluated, 41 (28 [68%] women) had tumor next-generation sequencing after acquired resistance to osimertinib. Among 13 patients (32%) with maintained T790M at the time of resistance, EGFR C797S was seen in 9 patients (22%). Among 28 individuals (68%) with lo...
Table 1. Acceptable Proficiency Testing Results of FDA Companion Diagnostics vs LDT for BRAF, EGFR, and KRAS View LargeDownload GeneFDA Companion Diagnositcs, No. (%)Laboratory-Developed Tests, No. (%)χ2 TestP Value BRAF All 300 (93.0) 2224 (96.6)a 9.1800 .002b Wild type 88 (100) 61...
Results Silencing of HHLA2 resulted in the inhibition of PC cell proliferation, migration and invasion, potentially through the suppression of the EGFR/MAPK/ERK and mTOR/AKT signaling pathway. Additionally, silencing HHLA2 led to the inhibition of M2-type polarization of tumor associated macrophages ...
The FDA has accepted a NDA for afatinib to treat patients with locally advanced or metastatic NSCLC who have tested positive for an EGFR mutation that has been identified through a companion diagnostic test. The FDA has accepted a new drug application (NDA) for afatinib to treat patients with ...
To evaluate the accuracy of the results of the PNA test, we compared plasma EGFR mutations with tumor sequencing in 40 paired donor-matched plasma and tumor tissue specimens. EGFR mutations were detected in the plasma samples of six (15.0%) patients, including four deletions in exon 19 and tw...
be a key barrier. For the majority of patients tested for EGFR mutations, results were available within 10 business days. However approximately one test result out of every four globally (24%*) was received later, meaning treatment decisions were possibly delayed or not informed by mutation ...
In addition, deterministic sensitivity analyses were performed to test the robustness of the results and to assess strategies that could improve cost-effectiveness, such as cost-sharing (2 first cycles free of charge) and risk-sharing (reimbursement of nonresponders’ cost). Model Structure In the...