QIAGEN's (QGEN) QCI Interpret Gets European IVDR Certification

QIAGEN N.V. QGEN recently announced the receipt of the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation for its updated version of its clinical decision support platform — QIAGEN Clinical Insight (QCI) Interpret. The recent regulatory approval ensures greater patient protection, transparency of information and traceability of data.

For investors’ note, QCI Interpret is a software that aids in interpreting genomic sequencing variants, enabling scientists and lab directors to identify, prioritize and report clinically relevant variants associated with various diseases.

More on the News

The first NGS interpretation platform approved by IVDR for use in cancer and hereditary applications is QIAGEN Clinical Insight Interpret. It complies with regulatory policy as a Class C IVD medical device, which means that it is a medical device software for clinical decision support and offers improved patient protection, information transparency and data traceability. Depending on the regulations for sale in the individual countries, clients in Europe will have access to the updated certified version later in 2024.

Worldwide, more than 4 million NGS patient test cases for genetic disorders and cancer were processed using QIAGEN Clinical Insight Interpret.

Significance of QIAGEN Clinical Insight Interpret

The QIAGEN Clinical Insight Interpret has received IVDR certification, which is additional evidence that the company’s clinical customers benefit from high-quality, regulatory-compliant software that enables scaling and acceleration of critical turn-around times and workflow efficiencies. The Augmented Molecular Intelligence approach to content curation and analysis, which has been utilizing humans and Artificial Intelligence (AI) and Machine Learning for more than 20 years, produces highly accurate and repeatable interpretation that is crucial for clinical decision support.

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The QIAGEN Clinical Insight Interpret product is a globally acknowledged quality standard that guarantees the uniform creation, advancement, manufacturing, setup and distribution of medical devices that are safe for their intended uses. Companies need to show that they can reliably fulfill customer and legal obligations while offering medical equipment and associated services.

Industry Prospects

Per a report, the global genomic cancer panel and profiling market is expected to reach $26.59 billion by 2033 from $9.90 billion in 2022. The global genomic cancer panel and profiling market is expected to grow at a robust rate of 9.43% during the forecast period 2023-2033. The upside is likely to be driven by advancements in genomic research and an increasing focus on precision medicine within the field of oncology.

Recent Developments

QIAGEN’s NGS portfolio witnessed strong double-digit revenue growth in the past few quarters. The company sees significant opportunities for NGS to deliver on the vision of precision medicine.

In first-quarter 2024, the Genomics/NGS group reported higher sales of universal library prep kits for use with third-party next-generation sequencers. QIAGEN is also considered a top provider of consumable and bioinformatics solutions for use with any next-generation sequencer. In those businesses, especially QDI for bioinformatics, QGEN has taken significant market share and delivered strong growth in the most recent years. The QDI business continued to see solid demand trends in the first quarter, setting out an optimistic CER growth outlook for the full year. It introduced a new software accelerator that significantly reduces the time and cost of NGS secondary analysis for somatic cancer.

Price Performance

In the past six months, QGEN’s shares have gained 12.5% compared with the industry’s rise of 7.6%.

Zacks Rank and Key Picks

QIAGEN currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Medpace MEDP, ResMed RMD and Encompass Health Corporation EHC.

Medpace, sporting a Zacks Rank #1 (Strong Buy), reported first-quarter 2024 EPS of $3.20. The figure beat the Zacks Consensus Estimate by 30.6%. Revenues of $511 million improved 17.7% from last year’s comparable figure. You can see the complete list of today’s Zacks #1 Rank stocks here.

Medpace has an estimated 2024 earnings growth rate of 26.5% compared with the industry’s 12.3%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 12.8%.

ResMed, sporting a Zacks Rank #2 (Buy), reported a first-quarter 2024 EPS of $2.13, which topped the Zacks Consensus Estimate by 10.9%. Revenues of $1.20 billion surpassed the Zacks Consensus Estimate by 1.9%.

RMD has an estimated fiscal 2024 earnings growth rate of 17.9% compared with the industry’s 15.7%. In each of the trailing four quarters, the company delivered an average earnings surprise of 2.8%.

Encompass Health, carrying a Zacks Rank #2, reported a first-quarter 2024 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 20.4%. Net operating revenues of $1.3 billion topped the Zacks Consensus Estimate by 3.6%.

EHC has an estimated long-term earnings growth rate of 15.6% compared with the industry’s 11.7% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 18.7%.
 

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