Roche Receives FDA Approval For Its Cobas KRAS Mutation Test

Roche Receives FDA Approval For Its Cobas KRAS Mutation Test

Roche recently announced that the United States Food and Drug Administration (FDA) has approved its cobas KRAS Mutation Test to be used for diagnostic purposes. This real-time PCR test was developed to find KRAS mutations in tumor samples that are collected from patients with metastatic colorectal cancer (mCRC) and help clinicians to better determine a suitable therapeutic path.

“As more targeted treatment options for cancer patients become available, the importance of identifying the right molecular information to define their disease becomes critical. The cobas® KRAS Mutation Test gives clinicians actionable insights that enable them to make informed decisions about treatment for their patient. With this approval, Roche now offers the most comprehensive companion diagnostic FDA approved portfolio for oncology in the U.S., including tests for BRAF (melanoma), EGFR (lung cancer) and KRAS (mCRC) mutations,” explained Paul Brown, the Head of Roche Molecular Diagnostics.

According to estimates from the Centers for Disease Control and Prevention, colorectal cancer is the number two cause of cancer-related deaths for Americans and the number three most frequent cancer in both women and men.  The cobas® KRAS Mutation Test aims to identify mCRC patients for whom the treatment with either Vectibix® (panitumumab) or Erbitux® (cetuximab) may be effective if there is no KRAS mutation present.

The cobs® KRAS Mutation Test consists of the TaqMelt™ assay, a diagnostic test based on polymerase chain reaction (PCR) that can detect mutations in codons 12 and 13 of the KRAS gene. This test can be executed in less than 8 hours, allowing physicians to make better and faster treatment decisions.

Further, the test is executed on the cobas® 4800 System, offering high-performance detection and amplification supported with highly efficient software that automates data interpretation and outcomes’ reports. The cobas® 4800 System for oncology in the United States includes the cobas® BRAF V600 Mutation Test, the cobas® KRAS Mutation Test and the cobas® EGFR Mutation Test.

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Isaura Santos graduated with a BS in Cell and Molecular Biology from Universidade Nova de Lisboa and a MA in Communication, Culture and Information Technologies from University Institute of Lisbon (ISCTE-IUL). Her professional interests include science communication, public awareness of science and communication of science through entertainment.

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