Test Bulletin
Effective: Wednesday, December 15, 2010
ACL Laboratories offers New Test Order Code for Referred Fungal Identification
Test Order Code: FUNGID
ACL Laboratories announces a new test order code: FUNGID -- Referred Fungal Identification for the submission of fungal isolates for Identification and/or Sensitivity testing. Previously, a single test order code: REFID -- Referred Culture existed for the submission of both bacterial and fungal isolates. The REFID test order code will now be used for bacterial isolates only with the new code being used for fungal isolates.
ACL Laboratories offers EGFR Gene Mutation Analysis
ACL Laboratories is pleased to offer EGFRGene Mutation Analysis for predicting response toEGFR-targeted therapy. Testing can beperformed on formalin-fixed, paraffin embedded tumor tissue. Primary resected tumor material is the preferred specimen to ensure adequate analysis.
The development of novel therapeutic agents targeting the epidermal growth factor
receptor, e.g. small molecular inhibitors ofEGFR tyrosine kinases and anti-EGFRmonoclonal antibodies, has made EGFR apromising target for anti-cancer therapies. Anti-EGFR agents have improved outcomesfor a subset of patients with colorectalcarcinoma or non-small cell lung carcinoma. The EGFR test offered by ACL Laboratories enables detection of 29 somatic mutations in EGFR gene. (Exon 18- G719S/A/C),Exon 19- 19 deletion plus, L858R, T790M, L858R, L861Q,,S768I and Exon 20 - 3 insertions.
Deregulation of EGFR signaling is common in non-small cell lung cancers (NSCLC) and this finding led to development of tyrosine kinase inhibitors (TKIs) that are highly effective in a subset of NSCLC. Mutation of EGFR and copy of number gains (CNGs) of EGFR and HER2 have been reported to predict for TKI response.
Biopsy material may be acceptable for thosepatients where primary tumor material isunavailable or who have received pre-surgery chemo-radiation therapy, if sufficient tumor material is present. Blocks selected for analysis must contain foci of tumor with a minimum of 50% tumor nuclei. ACL Laboratories Molecular PathologyDepartment performs real-time PCR based on DxS Scorpions technology.
BRAF Gene Mutation Analysis
ACL Laboratories is pleased to offer BRAFGene Mutation Analysis for predicting response toEGFR-targeted therapy. Testing can beperformed on formalin-fixed, paraffin embedded tumor tissue. Primary resected tumor material is the preferred specimen to ensure adequate analysis. Biopsy material may be acceptable for thosepatients where primary tumor material isunavailable or who have received pre-surgery chemo radiation therapy, if sufficient tumor material is present. Blocks selected for analysis must contain foci of tumor with a minimum of 50% tumor nuclei.
The development of novel therapeutic agents targeting the epidermal growth factorreceptor, e.g. small molecular inhibitors ofEGFR tyrosine kinases and anti-EGFRmonoclonal antibodies, has made EGFR apromising target for anti-cancer therapies. Anti-EGFR agents have improved outcomesfor a subset of patients with colorectalcarcinoma or non-small cell lung carcinoma. BRAFGene Mutation Analysis acts downstream of EGFR inintracellular signaling and activatingmutations in BRAFpredict lack of response to EGFR-targeted therapies.
BRAF mutation patients appear to not respond to anti EGFR medications. This mutation may identify up to 15% of the non-responder group in colorectal cancer alone.
ACL Laboratories Molecular PathologyDepartment performs PCR amplificationfollowed by Pyrosequencing analysis for tumors with mutation and wild type BRAFthat may respond to anti-EGFR therapy. This assay analyzes Mutations on Exon 11(codon 464-469) and Exon 15 (codon 595-600) of the BRAF gene.