Date: 2012-07-09
Type of information: Granting of a patent
Product name: therascreen® KRAS RGQ PCR Kit (therascreen KRAS test)
Compound: KRAS test - PCR companion diagnostic
Therapeutic area: Cancer - Oncology - Diagnostic
Action mechanism: The therascreen KRAS RGQ PCR Kit is a molecular diagnostic kit for detection of 7 somatic mutations in the KRAS gene using real-time PCR on the Rotor-Gene Q 5plex HRM Instrument.
Company: Qiagen (The Netherlands - Germany)
Disease: guidance on the use of Erbitux® (cetuximab) as a treatment in patients with metastatic colorectal cancer
Latest news: * On January 30, 2013, Qiagen has announced that Clarient – a GE Healthcare Company and leading provider of cancer laboratory testing services in the United States – has adopted the use of the therascreen® KRAS RGQ PCR Kit (therascreen KRAS test) as a companion diagnostic to guide the use of Erbitux® (cetuximab) as a treatment in patients with metastatic colorectal cancer. Clarient has a customer base of more than 2,000 pathologists, oncologists, clinical laboratories and hospitals.
* On July 6, 2012, the FDA has approved the first genetic test that can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux® (cetuximab) would be an effective treatment based on the absence of a gene mutation. Only patients with mutation-negative (wild-type) KRAS genes may benefit from anti-EGFR (epidermal growth factor receptor ) therapy. The therascreen KRAS RGQ PCR Kit can provide information about the KRAS gene mutation in patients whose CRC has spread to other parts of their body (metastasized). According to the U.S. product information for Erbitux®, KRAS status evaluation using an FDA-approved diagnostic test is used to determine treatment, and the therascreen KRAS kit is currently the only test with this status.
Following FDA approval, a number of laboratories will begin offering KRAS status evaluation with the therascreen KRAS test (Applied Diagnostics, Inc., Boyce & Bynum Pathology Laboratories, Cellnetix Pathology & Laboratories, Clinical Molecular Oncology Laboratory, The University of Kansas Medical Center, Colorado Molecular Correlates Laboratory (CMOCO), University of Colorado, Companion Dx Reference Lab, LLC, Dahl-Chase Diagnostic Services, Lab21 Inc, Mayo Clinic).
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-07-06
UE authorization:
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Favourable opinion USA:
Orphan status USA:
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Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
