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QIAGEN's FDA Nod for Expanded EGFR Test Use Widens Suite

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QIAGEN N.V. (QGEN - Free Report) recently announced the clearance of PMA Supplement for broadening the use of therascreen EGFR RGQ PCR Kit as a companion diagnostic with Pfizer Inc.’s (PFE - Free Report) VIZIMPRO (dacomitinib) by the FDA. It will be used for first-line treatment of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 L858R mutation.

EGFR RGQ PCR Kit in Details

Registered in more than 40 countries, the therascreen EGFR RGQ PCR kit stands approved as a companion diagnostic to guide the use of three FDA-approved therapies, including GILOTRIF (Afatinib) from Boehringer Ingelheim and Iressa (Gefitinib) from AstraZeneca (AZN - Free Report) .

The therascreen EGFR kit also provides laboratories an efficient workflow on the Rotor-Gene Q MDx along with distinguishing a comprehensive panel of EGFR mutations. Notably, Rotor-Gene Q MDx is a real-time PCR module in QIAGEN’s QIAsymphony family of instruments.

Market Potential

Non-small cell lung cancer occurs in around 85% of patients with a lung cancer condition, the leading cause of cancer deaths worldwide. Notably, EGFR mutations leading to growth in cancer cells occur in 10-35% of NSCLC tumors globally. However, EFGR mutations are responsive to treatments, particularly aiming at the the overactive EGFR protein which causes cancer cells to constantly grow and divide.

Progress With Test Menu expansion

QIAGEN is progressing well with the testing menu expansion strategy. Recently, it announced a new development under the company’s long-standing partnership with In Vitro Diagnostics (IVD) player DiaSorin S.p.A. .

This time, the alliance is set to offer a fully-automated CE-Marked testing for latent tuberculosis (TB) infection with QuantiFERON-TB Gold Plus Blood Collection Tubes (QFT-Plus BCT) on DiaSorin LIAISON Platforms.

Furthermore, in May, QIAGEN globally launched DNeasy PowerSoil Pro Kit, the next generation of sample technology for the extraction of fungal and bacterial DNA from a range of soil samples. The next month, the company launched the QIAseq 16S/ITS Panels and UCP Multiplex PCR Kit with a new generation of reagents to enable accurate microbial community profiling from complex microbiome samples.

In April, the company announced the receipt of pre-market approval by the FDA for PartoSure. In the same month, the company launched QIAstat-Dx in Europe following the closure of the recently-announced Stat-Dx acquisition and the completion of defined development activities by Stat-Dx. The company is planning to launch the test in the United States and other geographies in 2019. QIAGEN also launched two novel liquid biopsy panels, AdnaTest ProstateCancerPanel AR-V7 Kit and AdnaTest LungCancer Kit.

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