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QIAGEN (QGEN)-Mirati Deal to Boost Companion Diagnostic Arm

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QIAGEN N.V. (QGEN - Free Report) recently entered into a global collaboration deal with Mirati Therapeutics Inc.  to accelerate the development of a tissue-based KRAS companion diagnostic that detects KRAS G12C, a genetic mutation most prevalent in non-small cell lung cancer (NSCLC) and colorectal cancer(CRC). The agreement is initially focused on developing a tissue-based KRAS companion diagnostic which identifies NSCLC patients with KRAS G12C, eligible for Mirati’s innovative investigational cancer drug, adagrasib.

This collaboration is expected to expand QIAGEN’s therascreen KRAS testing portfolio based on real-time qualitative PCR for the QIAGEN Rotor-Gene Q MDx instrument and builds upon its decade-long expertise in KRAS companion diagnostic test. The deal also makes room for further diagnostic development in support of Mirati’s other oncology programs.

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 of Companion Diagnostics (CDx) assays and reduced clinical trial timelines have enhanced their adoption rate by pharmaceutical manufacturers. Also the issue of FDA’s “In Vitro Companion Diagnostic Devices” guidance, which enabled simultaneous approval of a diagnostic assay along with its corresponding therapeutic product, has facilitated collaboration between key pharmaceutical and diagnostic developers to co-develop drugs and oncology CDx assays.

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

Notable Developments

Among the company’s latest developments, in May, QIAGEN received the FDA’s Emergency Use Authorization for QIAreach Anti-SARS-CoV-2 Total Test. This COVID-19 total antibody test, developed in partnership with Australian digital diagnostics company Ellume, has a high sensitivity and specificity rate. It can process 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, which offers clinical labs to strengthen their COVID-19 testing capacity with existing infrastructure. Based on its QIAprep& technology launched in October 2020, this kit is expected to increase throughput of more than 670 tests per PCR cycler in an eight-hour shift.

In the same month, the company announced the launch of the LIAISON LymeDetect Assay, developed in collaboration with DiaSorin. The new LymeDetect solution based on QuantiFERON LymeDetect technology facilitates early detection of Lyme Borreliosis infection, thereby increasing the sensitivity of testing in the early phase of the disease.

Share Price Performance

The stock has outperformed its industry over the past year. It has grown 14.6% against the industry’s decline of 7.3 %.

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 - Free Report) , Computer Programs and Systems, Inc. (CPSI - Free Report) , and Illumina, Inc. (ILMN - Free Report) .

PetIQ, currently sporting a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 25.00%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Computer Programs and Systems, which carries a Zacks Rank #1, has a long-term earnings growth rate of 14.00%.

Illumina, which carries a Zacks Rank # 2 (Buy), has a long-term earnings growth rate of 7.00%.

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