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QIAGEN (QGEN) Launches Expanded Tissue CDx Kit for LUMAKRAS

·5 min read

QIAGEN N.V. QGEN recently received FDA approval of its therascreen KRAS RGQ PCR (Polymerase Chain Reaction) Kit for an expanded scope of use. The latest regulatory go-ahead enables it to be used as a companion diagnostic in guiding treatment with Amgen’s AMGN newly-approved lung cancer targeted drug LUMAKRASTM (sotorasib).

QIAGEN has also made the immediate launch of this expanded scope of companion diagnostic (CDx) claims for therascreen KRAS Kit following the approval. The test will be available under QIAGEN’s Day One Lab Readiness program.

More in the News

Lumakrastm (sotorasib) is the first and only FDA-approved targeted treatment for patients with KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). It is a first-in-class drug inhibitor of the G12C-mutated form of the KRAS protein, developed and marketed by Amgen.

QIAGEN’s therascreen tissue CDx KRAS Kit claims to detect KRAS G12C, a genetic mutation estimated to be present in up to 13% of cases of NSCLC and usually resistant to therapies.

The real-time qualitative PCR kit used with the Rotor-Gene Q MDx instrument is expected to build upon QIAGEN’s nine-year experience in KRAS CDx test development and commercialization. For investors’ note, Rotor-Gene Q MDx is a member of QIAGEN’s modular QIAsymphony family of automation solutions. The launch is expected to expand the company’s therascreen portfolio of companion diagnostic tests.

Zacks Investment Research
Zacks Investment Research

The therascreen KRAS Kit co-approved with LUMAKRAS was used in CodeBreaK 100 clinical trial of sotorasib drug.

More About the Launch

To benefit patients, QIAGEN has accelerated the launch of advanced diagnostics by making the therascreen KRAS Kit for NSCLC samples readily available at leading laboratories across the United States, through its Day-One Lab Readiness program for Precision Medicine.

Industry Prospects

Per a report published in Grand View Research, the global oncology companion diagnostic market size is expected to see a CAGR of 12.7% from 2020 to 2027. Economic benefits and reduced clinical trial timelines of CDx assays, the FDA’s authorization of simultaneous approval of a diagnostic assay along with its corresponding therapeutic product are among the key factors fueling market growth.

QIAGEN’s advanced technologies, ranging from next-generation sequencing (NGS) to polymerase chain reaction (PCR), have led it to become a global leader in companion diagnostic development. At present, QIAGEN has 10FDA approved PCR-based companion diagnostic indications and is working with more than 25 pharmaceutical and biotechnology companies to develop and commercialize companion diagnostic tests that advance Precision Medicine.

Notable Developments

Among the company’s latest developments, in May, QIAGEN entered into a global collaboration deal with Mirati Therapeutics Inc. to accelerate the development of a tissue-based KRAS companion diagnostic which identifies NSCLC patients with KRASG12C mutation, eligible for Mirati’s adagrasib, a selective and potent oral inhibitor of KRAS G12C.

In the same month, QIAGEN received the FDA’s Emergency Use Authorization for QIAreachAnti-SARS-CoV-2 Total Test, developed in partnership with Australian digital diagnostics company Ellume. This COVID-19 total antibody test processes up to 32 swab samples per hour and provides easy-to-read results on Ellume’s proprietary eHub in approximately 10 minutes.

In April, the company announced the launch of artus SARS-CoV-2 Prep&Amp UM Kit, based on its QIAprep& technology. This kit helps clinical labs strengthen their COVID-19 testing capacity with existing infrastructure.

In the same month, the company announced the launch of the LIAISON LymeDetect Assay in collaboration with DiaSorin, to facilitate early detection of Lyme Borreliosis infection.

Share Price Performance

The stock has outperformed its industry over the past year. It has grown 13.0% against the industry’s decline of 8.0 %.

Zacks Rank and Key Picks

Currently, QIAGEN carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the broader medical space include PetIQ, Inc. PETQ, and National Vision Holdings, Inc. EYE, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

PetIQ has a long-term earnings growth rate of 25.00%.

National Vision has a long-term earnings growth rate of 23.00%.

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QIAGEN N.V. (QGEN) : Free Stock Analysis Report

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