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QIAGEN (QGEN), BioNTech to Develop Test to Identify SCCHN

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QIAGEN N.V. (QGEN - Free Report) has entered into a strategic collaboration with BioNTech SE with the aim of developing and commercializing a tissue-based therascreen test as a companion diagnostic (CDx). This assay, which will be used with investigational cancer treatment BNT113, will identify patients with squamous cell carcinoma of the head and neck (“SCCHN”) that are caused by specific infections by human papilloma virus (“HPV”).

For investors’ note, the assay will be utilized to detect the presence of HPV genotypes (an individual's collection of genes) and will be developed on QIAGEN´s RGQ MDx platform. Notably, the platform belongs to the QIAsymphony product line.

Further, QIAGEN aims to pursue global regulatory approvals, including Premarket Approval from the FDA for CDx.

Notably, QIAGEN is currently working under master collaboration agreements with more than 30 companies, including BioNTech, to develop and commercialize CDx tests for their drug candidates.

With the recent collaboration, QIAGEN aims to strengthen its foothold in the global Precision Medicine market. This is expected to significantly boost the company’s broader Molecular Diagnostics business on a global scale.

Rationale Behind the Partnership

Per a 2018 global cancer study, SCCHN is the sixth most common type of cancer, leading to numerous deaths per year. The WHO believes that the estimates will double by 2035, given that the incidence of HPV-related SCCHN has significantly increased in recent years.

Further, QIAGEN plans to expand the assay for use across HPV-led cancers, such as cervical cancer, to provide a universal HPV CDx for its pharmaceutical partners.

Per QIAGEN’s management, the company will leverage its position in HPV testing to commercialize the new HPV CDx in all target markets of BioNTech.

Industry Prospects

Per a report by Global Market Insights, the precision medicine market size was more than $57 billion in 2019 and is expected to exceed $119 billion by 2026, witnessing a CAGR of more than 11% between 2020 and 2026. Factors like rising prevalence of cancer and significant advancements in the field of gene therapy are expected to drive the market.

Given the market potential, the collaboration seems to have been timed well.

Recent Developments in Molecular Diagnostics

Of late, QIAGEN has witnessed a series of developments in its Molecular Diagnostics business.

The company, this month, announced the receipt of the CE-IVD mark and the European launch of the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test to identify influenzas A and B, respiratory syncytial virus (“RSV”) and SARS-CoV-2 infections. Additionally, the company has expanded specimen types that can be used on the existing NeuMoDx SARS-CoV-2 test. Notably, QIAGEN had fully acquired NeuMoDx in September.

Further this month, the company has started commercialization of a portable digital test — QIAreach SARS-CoV-2 Antigen Test — in the United States, to aid the laboratories to detect SARS-CoV-2 antigens in people with active infections in lesser time.

QIAGEN, in October, announced a non-exclusive agreement with Phase Genomics, Inc. to license specific patents to sell its EpiTect Hi-C kits in the United States. The same month, the company announced its plans to launch a straightforward approach to viral RNA epidemiology — QIAprep& Viral RNA UM Kit — that will significantly simplify and accelerate PCR analysis and remove key testing bottlenecks for SARS-CoV-2 and other RNA viruses.

Also, in October, the company launched the QIAseq Human Exome TR Insights — a solution combining high-performance chemistry with robust bioinformatics to enable customers to sequence and analyze multiple types of genomic variations across the entire human exome.

In August, QIAGEN announced the U.S. launch of the QIAreach Anti-SARS-CoV-2 Total Test — an easy-to-use digital test done on a portable device that provides faster results to detect antibodies in people exposed to the SARS-CoV-2 virus.

Price Performance

Shares of the company have gained 14.2% in the past year compared with the industry’s 2.8% rise and S&P 500’s 15.3% growth.

Zacks Rank & Key Picks

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

Some better-ranked stocks from the broader medical space are ResMed Inc. (RMD - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Align Technology, Inc. (ALGN - Free Report) .

ResMed’s long-term earnings growth rate is estimated at 14.5%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Thermo Fisher’s long-term earnings growth rate is estimated at 18%. It currently carries a Zacks Rank #2.

Align Technology’s long-term earnings growth rate is estimated at 18.3%. It currently flaunts a Zacks Rank #1.

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