Thermo Fisher & J&J Team Up To Develop Lung Cancer Companion Diagnostic

Thermo Fisher Scientific has inked a deal with Janssen Biotech, part of Johnson & Johnson, to co-develop a companion diagnostic for cancer. The diagnostic test will support global clinical trial enrollment.

Under the deal, Thermo Fisher will work with Janssen Research & Development to identify and validate multiple biomarkers for Thermo Fisher’s Oncomine Dx Target Text. This will be utilized to identify variant-positive patients for clinical trials for non-small cell lung cancer (NSCLC). It’s possible that the testing will be applicable to other cancer indications.

The Oncomine Dx Target Test is a next-generation sequencing (NGS) assay that evaluates 46 cancer-related biomarkers. It reportedly has a fast turnaround time and the lowest sample requirements on the market for both DNA and RNA variants. It was approved by the U.S. Food and Drug Administration (FDA) in 2017.

“The ability of the Oncomine Dx Target Test to rapidly detect variants of interest from very small quantities of DNA or RNA samples makes this technology ideally suited to support development programs requiring an NGS-based workflow that delivers actionable insights consistently,” said Peter Silvester, senior vice president and president of Life Sciences Solutions at Thermo Fisher. “We are confident that this approach to patient stratification helps expedite drug development initiatives which ultimately are designed to promote better health outcomes through targeted therapies.”

No financial terms were disclosed.

Earlier this month, on March 3, Thermo Fisher dramatically expanded its diagnostics capabilities by acquiring The Netherlands-based QIAGEN N.V. for $11.5 billion. It also took on $1.4 billion of net debt in the deal. Qiagen manufactures diagnostic tests for a variety of diseases including cancer and, currently, the coronavirus that causes COVID-19.

Qiagen employs about 5,100 staffers at 35 sites in more than 25 countries. In 2019, it raked in $1.53 billion in revenue. Thermo Fisher will benefit from the company’s molecular diagnostics technology, including infectious disease testing, as well as innovative sample preparation, assay and bioinformatics technology.

“We are excited to bring together our complementary offerings to advance our customers’ important work, from discovery to diagnostics,” said Marc N. Casper, Thermo Fisher’s chairman, president and chief executive officer, at the time. “This acquisition provides us with the opportunity to leverage our industry-leading capabilities and R&D expertise to accelerate innovation and address emerging healthcare needs. For shareholders, we expect the transaction to be immediately accretive and to generate significant cost and revenue synergies.”

The tie-in to the coronavirus was timely, but Thermo Fisher was interested in QIAGEN before the coronavirus outbreak began in January. The coronavirus test kits are being used in at least four China hospitals and one in France, and the company has applied for emergency authorization to market them in the U.S., Korea and China. They are expanded versions of the company’s QIAstat-Dx Respiratory Panel, used to test for other respiratory disease.

On February 26, QIAGEN announced worldwide shipments of the QIAstat-Dx test kits for SARS-CoV-2.

David , Qiagen’s chief medical officer and vice president of Medical Affairs for Infection and Immune Diagnostics, announced at the time, “QIAstat-Dx syndromic testing solution has fast time to result, ease of use and an existing respiratory panel that makes it a potential key asset in this situation, and we are currently adding a 2019-nCoV strain panel which is a new Research Use Only panel to the pathogens covered by this test.-Bio Space

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