QIAGEN (QGEN) to Develop CDx Test for TIBSOVO With New Pact
QIAGEN N.V.QGEN recently announced that it has entered into a strategic partnership with Servier. The agreement is intended to develop a companion diagnostic test for TIBSOVO — an isocitrate dehydrogenase-1 or IDH1 inhibitor indicated for treating the blood cancer acute myeloid leukemia or AML.
For investors’ note, QIAGEN has master collaboration deals to develop and commercialize companion diagnostics with over 30 global companies. QIAGEN has 11 PCR-based companion-diagnostics tests that have been approved by the FDA. Furthermore, the company announced partnerships with Neuron23 and Helix to develop companion diagnostics in disease areas outside oncology.
The recent development is likely to fortify QIAGEN’s Precision Diagnostics business.
More on Partnership
Under the master collaboration deal, QIAGEN will develop and validate a real-time in vitro PCR test that can be utilized to spot IDH1 gene mutations in AML patients in whole blood and bone marrow aspirates.
The company noted that the companion diagnostic would run on the QIAGEN Rotor-Gene Q MDx device, widely used by labs worldwide. QIAGEN's regulatory teams will aid clinical validation of the companion diagnostic and its approval in the United States, the European Union and Japan.
Patients with AML may deteriorate quickly if not treated early and QIAGEN is supporting Servier with a companion diagnostic in their goal to introduce innovative treatment for IDH1 mutated AML patients. At the same time, QIAGEN is fortifying its role in developing companion diagnostics for the ever-growing number of biomarkers discovered in onco-hematology.
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It is worth mentioning that AML is a hard-to-treat cancer of the blood and bone marrow and is one of the most common types of leukemia in adults. With the latest partnership, QIAGEN will be able to expand the global access for TIBSOVO for patients with its global footprint in oncology-driven diagnostics and proven expertise in companion diagnostics development and approvals.
Per a report by BCC Research, the global market for companion diagnostics (CDx) was $5.4 billion in 2021 and is expected to reach $10.7 billion by 2026, at a CAGR of 14.6%. The rising prevalence of chronic diseases has increased the market adoption of companion diagnostics. Furthermore, increasing healthcare expenditure with the rise in the standard of living and availability of technology coupled with demand for precision medicine is expected to fuel the market further.
In January 2023, QIAGEN’s bioinformatics business, QIAGEN Digital Insights, announced its enhanced QIAGEN CLC Genomics Workbench Premium that removes the data-analysis bottleneck of next-generation sequencing (NGS) by adding innovative analysis speed to analyze and interpret whole genome sequencing, whole exome sequencing and large panel sequencing data.
The same month, QIAGEN completed the acquisition of Verogen, a renowned name in the use of NGS technologies to drive the future of human identification and forensic investigation.
Shares of the company have gained 4.2% in a year against the industry’s fall of 9.6%.
Zacks Rank and Key Picks
Currently, QIAGEN carries a Zacks Rank #3 (Hold).
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