QIAGEN’s NeuMoDx HAdV Quant Test (QGEN) Achieves CE-IVD Mark



QIAGEN SA QGEN recently announced the receipt of CE-IVD certification for its NeuMoDx HAdV assay to the European Union and countries that accept this marking to identify and quantify human adenovirus (HAdV) DNA. By achieving CE-IVD certification, QIAGEN is driving the deployment of non-COVID-19 testing in the United States, Europe and other markets.

It should be mentioned that this step marks the 15th test available on the NeuMoDx 96 and 288 molecular systems with a CE-IVD mark, one of the widest menus for integrated PCR tests.

The NeuMoDx HAdV Quant assay was developed in collaboration with Sentinel Diagnostics, an IVD company specializing in the development and production of diagnostic kits for clinical chemistry, immunochemistry and molecular diagnostics. Tests can be run in true random access with Laboratory Developed Tests (LDT).

More in the news

Currently, NeuMoDx solutions offer CE-IVD testing for various viral and bacterial pathogens. The availability of the HAdV assay strengthens the current menu of the NeuMoDx transplant assay which includes CE marked assays for monitoring cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) viral load for the management of immunocompromised patients such as those who have had an organ transplant. The menu also includes tests that cover sexual and reproductive health, including HPV and Chlamydia trachomatis.

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

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Industry outlook

According to 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, with a CAGR of 17.5%.

Given the growing market, QIAGEN’s recent development in its PCR test portfolio is timely.

Growth of PCR test solutions

QIAGEN, in its first quarter 2021 results update, noted that sales of QIAstat-Dx and NeuMoDx solutions remain high due to strong demand for COVID-19 testing and increasing use of other applications. clinical tests. 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 US menu expanded with the receipt of emergency use authorization for a 4-plex test, with simultaneous detection of influenza A and B. , RSV and SARS-CoV-2.

Price return

The company’s shares gained 11.2% in one year compared to an industry drop of 4.8%.

Zacks rank and choice of keys

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

Some better classified actions of the wider medical space are Envista Holding Company NVST, BellRing Brands, Inc. BRBR and Baxter International Inc. BAX, each wearing a Zacks Rank # 2 (Buy). You can see The full 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 profit growth rate of 22%.

Baxter International has forecast a long-term profit growth rate of 9%.

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