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QIAGEN's (QGEN) NeuMoDx HAdV Quant Assay Wins CE-IVD Mark

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QIAGEN N.V. QGEN recently announced the receipt of CE-IVD certification for its NeuMoDx HAdV Quant Assay for the European Union and countries that accept this marking to identify and quantify human adenovirus (HAdV) DNA. By securing CE-IVD certification, QIAGEN drives the deployment of non-COVID-19 tests in the United States, Europe and other markets.

It is worth mentioning that this milestone marks the 15th assay available on the NeuMoDx 96 and 288 Molecular Systems with a CE-IVD marking, one of the broadest menus for integrated PCR testing.

The NeuMoDx HAdV Quant Assay was developed in collaboration with Sentinel Diagnostics -- an IVD company focused on the development and production of diagnostic kits for Clinical Chemistry, Immunochemistry and Molecular Diagnostics. The tests can run in true random access together with Laboratory Developed Tests (LDTs).

More in the News

At present, the NeuMoDx solutions offer CE-IVD tests for various viral and bacterial pathogens. The availability of the HAdV assay fortifies the current NeuMoDx transplant assay menu that includes CE-marked tests for cytomegalovirus (CMV), Epstein–Barr virus (EBV) and BK Virus (BKV) viral load monitoring for the management of immunocompromised patients like those who have undergone organ transplantation. The menu also comprises assays which cover sexual and reproductive health, including HPV and Chlamydia trachomatis.

Each of these assays utilizes QIAGEN’s automated, three-step NeuMoDx solutions that extract DNA from blood or urine to separate the target nucleic acids and then carry out a real-time polymerase chain reaction (RT-PCR) to target conserved sequences in the HAdV genome.

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Industry Prospects

Per a report by Grand View Research, the global PCR market size was valued at $4.5 billion in 2019 and is expected to reach $16.2 billion by 2027, at a CAGR of 17.5%.

Considering the market growth, the recent development by QIAGEN in its PCR testing portfolio is well-timed.

Growth in PCR Testing Solutions

QIAGEN, during its first-quarter 2021 earnings update, noted that sales of QIAstat-Dx and NeuMoDx solutions remained high on robust demand for COVID-19 testing and increasing use of other clinical testing applications. For NeuMoDx, the integrated PCR testing platform, the company is on track for Q-FDA submissions plans in 2021.

QIAGEN also noted that in the first quarter of 2021, the company’s U.S. menu has expanded with the receipt of the emergency use authorization for a 4-plex test, with simultaneous detection of flu A and B, RSV, and SARS-CoV-2.

Price Performance

Shares of the company have gained 11.2% in a year’s time against the industry’s fall of 4.8%.

Zacks Rank and Key Picks

Currently, the company carries a Zacks Rank #5 (Strong Sell).

A few better-ranked stocks from the broader medical space are Envista Holdings Corporation NVST, BellRing Brands, Inc. BRBR and Baxter International Inc. BAX, each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.

Envista Holdings has an estimated long-term earnings growth rate of 26%.

BellRing Brands has an estimated long-term earnings growth rate of 22%.

Baxter International has a projected long-term earnings growth rate of 9%.

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Baxter International Inc. (BAX) : Free Stock Analysis Report

QIAGEN N.V. (QGEN) : Free Stock Analysis Report

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