Illumina (ILMN) NGS-Based Platform Approved for Use in Russia
Illumina, Inc. ILMN recently announced the receipt of medical device registration for its NextSeq 550Dx next-generation sequencing (NGS) platform, associated reagent kits and reagents for the company’s MiSeq Dx. Notably, Illumina’s in-vitro diagnostics (IVD) platforms have been approved for use in Russia by the country’s medical device regulatory agency, Roszdravnadzor.
NextSeq 550Dx and MiSeq Dx are IVD-ready solutions being made available to customers and third-party developers to develop diagnostics solutions using the technology.
For investor’s note, the regulatory process was led by Illumina’s strategic partner in Russia and Commonwealth of Independent States (CIS), R-Pharm, which marked the first approval by the agency for a complete set of sequencing instruments plus reagents.
The recent development will strengthen Illumina’s NGS portfolio.
Significance of the Registration
Per Illumina’s management, the registration of the two IVD-platforms will enable developers to boost the clinical use of NGS-based molecular diagnostics. Notably, this will boost the testing solution for genetic diseases and oncology in Russia.
The registrations of IVD platform in Russia is a significant step in bringing NGS technologies with accurate and validated results that will significantly benefit patients. These registrations are expected to foster the development of sequencing-based clinical diagnostics in Russia.
Industry Prospects
Per a report by Grand View Research, the global next generation sequencing market size was worth $3.99 billion in 2020 and is expected to see a CAGR of 14.4% by 2028. Considering the market growth, Illumina is constantly working toward the development of NGS-based IVD solutions.
The recent authorization is well-timed considering market opportunities.
Notable Developments
In January 2021, Illumina collaborated with Sequoia Capital to drive the startup ecosystem in China with the launch of the Sequoia Capital China Intelligent Healthcare Genomics Incubator, powered by Illumina. Notably, with the alliance, Illumina will focus on establishing life sciences startup companies specialized in genomics.
In the same month, Illumina partnered with Myriad Genetics to provide comprehensive genomic profiling of tumor samples and derive better outcomes in oncology. Per the agreement, Illumina will create a kit-based version of Myriad Genetics’ myChoice companion diagnostic test for the international market.
Price Performance
Shares of the company have surged 53.5% in a year’s time compared with the industry’s growth of 10.3%.
Zacks Rank and Key Picks
Currently, Illumina carries a Zacks Rank #4 (Sell).
A few better-ranked socks from the broader medical space are Acorda Therapeutics, Inc. ACOR, Atea Pharmaceuticals, Inc. AVIR and Clearside Biomedical, Inc. CLSD, each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.
Acorda Therapeutics has a projected long-term earnings growth rate of 15%.
Atea Pharmaceuticals has a projected long-term earnings growth rate of 164%.
Clearside Biomedical has an estimated long-term earnings growth rate of 24%.
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