Abstract
Thermo Fisher Scientific announced plans in March to acquire Qiagen in a $11.5 billion deal that could bring morediagnostic offeringsand sample-preparation technologies to one of the world's leading manufacturers of scientific instruments, research services, and laboratory consumables.
Thermo Fisher Scientific announced plans this month to acquire Qiagen in an $11.5 billion deal that could bring more diagnostic offerings and sample-preparation technologies to one of the world's leading manufacturers of scientific instruments, research services, and laboratory consumables.
Qiagen garnered headlines in February for rapidly adapting its test kits to detect the novel coronavirus, creating a molecular diagnostic for use in China—and Thermo has since done the same in the United States. Among cancer researchers, however, Qiagen is perhaps better known for two things: products that purify DNA or RNA from samples, and clinical assays that can determine a patient's mutation status and help physicians tailor treatments accordingly.
These companion diagnostics (CDx) include Qiagen's four “therascreen” tests, which variously detect mutations in EGFR, FGFR3, KRAS, and PIK3CA to guide treatment decisions for seven different therapies including afatinib (Gilotrif; Boehringer Ingelheim), panitumumab (Vectibix; Amgen), erdafitinib (Balversa; Janssen), and alpelisib (Piqray; Novartis).
The company also sells a JAK2 assay designed to help clinicians accurately diagnose polycythemia vera by screening for a DNA substitution found in more than 94% of patients with the myeloproliferative neoplasm, and a test for high-risk strains of human papillomavirus to aid in screening for cervical cancer. Plus, Qiagen offers research-grade kits for profiling tumor mutation burden and for analyzing circulating tumor cells.
Yet, no one product in Qiagen's oncology product line—from its sample prep and analytic tools to downstream bioinformatics solutions—is likely as important to Thermo as the regulatory know-how that the firm brings to the table in the CDx arena, says Stephane Budel, PhD, a founding partner at DeciBio, a life sciences consulting firm in Los Angeles, CA. “Don't even think about the specific items in the portfolio,” he advises. “One of the most underrated drivers of the acquisition on the oncology side is Qiagen's expertise in pushing CDx through the FDA.”
Thermo, for its part, offers a series of complementary research tools for studying solid tumors, analyzing immune–tumor interactions, and performing liquid biopsies. The company also has two FDA-cleared clinical diagnostics: the SPOT-Light test for HER2 amplifications linked to breast cancer, and the Oncomine Dx Target Test, the first next-generation sequencing (NGS)–based assay approved for non–small cell lung cancer.
Oncomine involves screening tumor samples for DNA and RNA variants associated with 23 genes, including three—BRAF, ROS1, and EGFR—validated to inform patient eligibility for three different treatment regimens. Looking to expand the reach of the diagnostic aid, Thermo recently signed two collaborative research deals: one with Eli Lilly centered on RET alterations to identify patients who stand to benefit from selpercatinib (LOXO-292), a RET inhibitor now under review by regulatory agencies around the world; and one with Janssen focused more generally on investigational lung cancer therapeutics.
NGS has been less of a priority at Qiagen, which has doubled down on targeted PCR-based assays. Last year, the company halted development of its GeneReader sequencing system and instead allied with Illumina, an industry leader in NGS technologies, in a 15-year research pact geared toward making diagnostic kits for use on Illumina's MiSeq and NextSeq platforms.
Should the Qiagen deal go through, it is unclear whether Thermo Fisher, maker of the competing Ion Torrent sequencer, will maintain ties with Illumina. Thermo Fisher declined to comment. –Elie Dolgin
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