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Illumina MiSeq Dx Okayed in China, NGS Platform Gets a Boost

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Illumina, Inc. (ILMN - Free Report) recently announced the receipt of approval from the China National Drug Administration (CNDA) for its next-generation sequencing (NGS) MiSeq Dx Sequencing System. With this, Illumina is authorized to commercially launch the MiSeqDx Sequencing System in hospitals and other medical institutions for in-vitro diagnostic testing across China.

What is MiSeqDx Sequencing System?

MiSeqDx Sequencing System is a benchtop sequencer which will help medical institutions in developing new clinical assays and will also aid in-vitro diagnostic (IVD) developers in creating accurate diagnostic testing. This NGS system incorporates an easy-to-use workflow and data output to meet the varying needs of clinical labs. Furthermore, integrated software allows run setup, sample tracking, user management, audit trails and data interpretation.

Notably, the MiSeqDx Sequencing System already has received regulatory approval in the United States, Canada, Argentina, European countries accepting the CE-IVD mark, Australia, South Korea, Singapore, Thailand and the Philippines, in the past.

NGS Platform in Focus

Illumina recently announced the acquisition of Edico Genome to strengthen the NGS platform. Per the company, the Edico Genome’s DRAGEN Bio-IT (DRAGEN) platform complements Illumina’s sequencing portfolio and helps in delivering rapid and streamlined output for NGS customers.

The company also recently introduced a second FDA-regulated and CE-IVD marked NGS system — NextSeq 550Dx.  The company has received product approval for the NextSeq 550Dx instrument from the Ministry of Food and Drug Safety (MFDS) in South Korea as well.

In April, the company collaborated with Bristol-Myers Squibb Company (BMY) in the field of oncology. Bristol-Myers Squibb will utilize Illumina’s NGS technology to develop and globally commercialize IVD assays to support its oncology portfolio.

Illumina also announced a global strategic partnership with Loxo Oncology to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, NGS-based companion diagnostic (CDx) with a pan-cancer indication.

Market Potential

According to Markets and Markets, the global next-generation sequencing market is estimated to reach a worth of $12.45 billion by 2022, at a CAGR of 20.5%. This shows that the approval has come at the right time and will help Illumina cash in on the bountiful NGS market opportunities.

Share Price Performance

Over the past year, Illumina has outperformed its industry. The company has gained 71.5% against the industry’s decline of 12.4%.

Zacks Rank and Other Key Picks

Illumina currently carries a Zacks Rank #1 (Strong Buy).

Other top-ranked stocks in the broader medical space are Integer Holdings Corporation (ITGR - Free Report) , Intuitive Surgical (ISRG - Free Report) and Masimo Corporation (MASI - Free Report) .

Integer Holdings’ expected long-term earnings growth rate is 15%. The stock sports a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.

Intuitive Surgical’s long-term expected earnings growth rate is 14.7%. The stock carries a Zacks Rank #1.

Masimo’s long-term expected earnings growth rate is 14.8%. The stock has a Zacks Rank #2 (Buy).

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