IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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TRENDS & PERSPECTIVES Companion-Diagnostic Products Enter the Mainstream Within the past 18 months, four new companion-diagnostic products have been approved by FDA and have hit the market, ofering confrmation that personalized medicine is making its way into the mainstream slowly but surely. Lung cancer, breast cancer, and melanoma are the target diseases of the most recent crop of companiondiagnostic products to achieve commercialization. Te following four remarkable new products were recently approved by FDA. Bond Oracle Her2 IHC System Manufactured by Leica Biosystems (owned by Danaher), this test complements the drug Herceptin (trastuzumab) and is a semi-quantitative immunohistochemical assay to determine Her2 oncoprotein status in formalin-fxed, parafn-embedded breast cancer tissue processed for evaluation following automated staining on Leica's Bond-Max slide-staining instrument. Te assay helps select patients for Herceptin treatment. It was approved by FDA in April 2012. The Bond Oracle Her2 IHC assay from Leica Biosystems helps select patients for Herceptin treatment. Cobas EGFR Mutation Test THxID BRAF Kit Tis real-time PCR test manufactured by Roche Molecular Systems qualitatively detects exon 19 deletions and exon 21 (L858R) substitution mutations of the EGFR gene in DNA derived from non-small-cell lung-cancer (NSCLC) tumor tissue. It is intended to help select patients with metastatic NSCLC for whom Tarceva (erlotinib), an EGFR tyrosine kinase inhibitor, is indicated. Te test was the frst FDA-approved companion diagnostic test to detect EGFR gene mutations, which are present in approximately 10% of NSCLC cases. It was approved in May 2013. BioMérieux manufactures this IVD that qualitatively detects the BRAF V600E and V600K mutations in DNA samples extracted from melanoma tissue. Te kit is a realtime PCR test that runs on the ABI 7500 Fast Dx system and is used to help select melanoma patients whose tumors carry the BRAF V600E mutation for treatment with Tafnlar (dabrafenib) and the V600K mutation for treatment with Mekinist (trametinib). It is the second approved companiondiagnostic test for melanoma and was greenlit by FDA in late May 2013 The Cobas EGFR Mutation test from Roche Molecular Systems is the first FDAapproved companion diagnostic for the detection of EGFR gene mutations. Therascreen EGFR RGQ PCR Kit Tis kit, manufactured by Qiagen, is another EGFR-mutation test for NSCLC patients. Its corresponding drug is Gilotrif (afatinib), and it is approved for patients with metastatic NSCLC, whose tumors express the exon 19 deletion or exon 21 substitution mutations. Te test performs realtime PCR; specimens are processed using the QIAmp DSP DNA FFPE Tissue kit for manual sample prep, and the Rotor-Gene Q MDx instrument for automated amplifcation and detection. Te kit was approved in July 2013. —Maureen Kingsley 6 IVD TEC HNOLO G Y | FA L L 2013 magenta cyan yellow black ES323621_IV1309_006.pgs 09.24.2013 02:21 UBM

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