Thermo Fisher's (TMO) Oncomine Dx Gets CDx Approval From MHLW

Thermo Fisher Scientific Inc. TMO recently gained regulatory approval from Japan’s regulatory agency – the Japan Ministry of Health, Labour and Welfare (MHLW) – for the Oncomine Dx Target Test as a next-generation sequencing (NGS)-based companion diagnostic (CDx) intended for patients with RET-fusion positive non-small-cell lung cancer (NSCLC). These patients, in fact, can be treated with Eli Lilly and Company's LLY selpercatinib (formerly known as LOXO-292).

The selpercatinib is a tyrosine kinase inhibitor that selectively binds to the RET receptor. It was granted an orphan drug designation by the MHLW in 2020.

Per management, the recent approval for Oncomine Dx Target Test from MHLW will help NSCLC-patients whose tumors are positive for fusions in the RET receptor, by offering them access to new, potentially more effective treatments.

This authorization is likely to expand Thermo Fisher’s NGS-based CDx solutions to advance precision medicine.

More on the News

At present, Thermo Fisher offers the only globally-distributable NGS CDx that has been approved and reimbursed by government and commercial insurers in more than 15 countries. In fact, this NGS-based CDx is available in countries like the United States, several European nations, Japan, South Korea and the Middle East, covering more than 550 million lives worldwide.

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The Oncomine Dx Target Test has been approved in Japan for five biomarkers with a total of 10 associated targeted therapies for NSCLC patients.

Industry Prospects

Per a report published in MarketsandMarkets, the companion diagnostics market is set to witness a CAGR of 12.9% during the forecast period of 2020 to 2025. Major factors driving the market include growing demand for next-generation sequencing, increasing importance of companion diagnostics in drug development and rising number of clinical trials. Other factors such as several advantages of CDx, increasing need for targeted therapy, growing importance of personalized medicine, increasing incidence of cancer worldwide and the ever-rising application areas of CDx are driving the market further.

Given the substantial market prospects, the recent authorization for Thermo Fisher’s Oncomine Dx Target Test as a NGS-based CDx for selpercatinib seems strategic.

Notable Developments

Thermo Fisher is engaging in a number of significant developments this month.

The company has introduced the new Thermo Scientific Vanquish Neo UHPLC System and Thermo Scientific PepMap Neo Columns, which are intended for high sensitivity LC-mass spectrometry (LC-MS) applications, technical capabilities and ease of integration with Thermo Scientific PepMap Neo Columns and Thermo Scientific mass-spectrometry portfolio. The Vanquish Neo UHPLC System and PepMap Neo Columns enable users to overcome the constraints associated with the existing low-flow LC instruments.

The company has been awarded a $192.5-million contract by the U.S. Department of Defense (DoD) to ensure reliable domestic production of pipette tips. With the DoD contract, the company will co-invest with the U.S. government to build a new, state-of-the-art, energy efficient manufacturing facility for pipette tips in North Carolina. This contract has been given on behalf of and in coordination with the U.S. Department of Health and Human Services (HHS).

Thermo Fisher’s clinical sequencing business and AstraZeneca have collaborated to co-develop NGS-based CDx to support AstraZeneca's expanding portfolio of targeted therapies. The companies collaborated under a multi-year global agreement, to accelerate the development and introduction of targeted precision medicine therapies.

Share Price Performance

The stock has outperformed its industry over the past year. It has grown 29.7% compared to the industry’s growth of 14.1%.

Zacks Rank and Key Picks

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

Two better-ranked stocks from the Medical-Instruments industry include Semler Scientific Inc. SMLR and IDEXX Laboratories, Inc. IDXX, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s  Zacks #1 Rank (Strong Buy) stocks here.

Semler Scientific has a long-term earnings growth rate of 25%.

IDEXX has a long-term earnings growth rate of 19.9%.

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Eli Lilly and Company (LLY): Free Stock Analysis Report

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