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QIAGEN (QGEN) Assays to Detect Organ Transplant-Related Viruses

QIAGEN N.V. QGEN recently introduced new CE-IVD certified additions to its comprehensive NeuMoDx assay menu for organ transplant-associated viruses. The assays are available in the European Union and other countries recognizing this marking. These are intended for the detection and quantification of the Epstein-Barr virus (EBV) and the human herpesvirus 6 (HHV-6).

The newly-announced assays align with QIAGEN’s strategy to extend the menu of tests that can be used on the NeuMoDx 96 and 288 Molecular Systems. The systems deliver one the most extensive selections of tests on the market, with 16 EU-certified in-vitro diagnostics (CE-IVD) tests currently available.

Few Words on NeuMoDx Assay Menu

The NeuMoDx assay menu for transplant-associated viruses is utilized for viral load monitoring in immunocompromised patients such as organ transplant patients. The assay menu offers CE-marked tests for cytomegalovirus (CMV), BK Virus (BKV), human adenovirus (hAdV) and herpes simplex virus type 1 (HSV-1) and/or herpes simplex virus type 2 (HSV-2).

The NeuMoDx assay menu completely automates laboratory workflows and reduces wastage. The assay menu is based on a microfluidic cartridge and allows the running of 12 reactions at once. The results can be observed in about an hour, with a walk-away time of up to eight hours. The NeuMoDx solutions also provide CE-IVD tests for blood-borne viruses and assays covering sexual and reproductive health, including HPV and Chlamydia trachomatis.

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Other Planned Launches

QIAGEN is in the works to introduce other assays that would leverage the automated, three-step NeuMoDx solutions to extract DNA from blood or urine, isolate the target nucleic acids and conduct a real-time polymerase chain reaction (RT-PCR) afterward. These assays include the Monkeypox RUO Assay, which will be launched in 2022 as a commercial multiplex assay for research and surveillance of the two known forms of the monkeypox virus (Clade I and Clade II).

Apart from this, QIAGEN is developing a new multiple-target test: NeuMoDxFluA/FluB/RSV/SARS-CoV-2 Assay with a new dual-target SARS-CoV-2 design. The assay identifies and distinguishes between the two most prevalent strains of influenza (A and B), respiratory syncytial virus (RSV) and SARS-CoV-2, in individuals suspected of respiratory viral infection.

Industry Prospects

Per a report published in GlobeNewswire, the global market for viral disease diagnosis is expected to see a CAGR of 6.2% during 2022-2030. Factors such as the increasing spread of SARS-CoV 2 virus, the growing uptake of diagnostic kits and rapid tests for viral disease detection and greater research and development for virus detection can be attributed to market growth.

Given the market prospects, QIAGEN’s latest addition to the NeuMoDx assay menu seems strategic.

Notable Developments

This month, QIAGEN signed an agreement with Neuron23 Inc. to develop a companion diagnostic testing for the latter’s brain penetrant leucine-rich repeat kinase (LRRK2) inhibitor for Parkinson’s disease. The Master Collaboration Agreement requires QIAGEN to create and validate a clinical trial assay that identifies a combination of biomarkers discovered by Neuron23. The agreement also includes options for developing additional companion diagnostics in the future, subject to further clinical development.

In August 2022, the company launched the QIAstat-Dx Viral Vesicular Panel RUO— the first syndromic test to distinguish between monkeypox and five other pathogens causing similar symptoms. The novel research use only (RUO) panel is available in cartridge form that can be run on QIAGEN’s QIAstat-Dx automated syndromic testing devices. It is part of the company’s efforts to combat the spread of monkeypox.

Share Price Performance

The stock has outperformed its industry in the past year. It has lost 20.7% compared with the industry’s 38.8% fall.

Zacks Rank and Key Picks

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

A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. AMN, ShockWave Medical, Inc. SWAV and McKesson Corporation MCK.

AMN Healthcare has a long-term earnings growth rate of 3.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.7%, on average. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AMN Healthcare has outperformed its industry in the past year. AMN has lost 4.2% against the industry’s 35.9% fall.

ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. The company’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.

ShockWave Medical has outperformed its industry in the past year. SWAV has gained 33.4% against the industry’s 31.4% fall in the past year.

McKesson has an estimated long-term growth rate of 9.9%. The company surpassed earnings estimates in the trailing three quarters and missed in one, delivering a surprise of 13%, on average. It currently carries a Zacks Rank #2 (Buy).

McKesson has outperformed its industry in the past year. MCK has gained 71.5% against the industry’s 15.1% fall.


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