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QIAGEN and AstraZeneca Expand Pact to Develop CDx in Chronic Diseases

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QIAGEN N.V. (QGEN - Free Report) has expanded its Master Collaboration Agreement with AstraZeneca (AZN - Free Report) to develop and commercialize companion diagnostics (CDx) for AstraZeneca’s future therapies targeting chronic diseases. The collaboration will see QIAGEN developing and validating a genotyping assay using its QIAstat-Dx syndromic testing platform.

The recent development is poised to enhance the company’s Molecular Diagnostics business.

Significance of QIAGEN’s Expanded Partnership

The new QIAstat-Dx genotyping assay, being developed through the expanded partnership with AstraZeneca, will enable specialty care providers to potentially perform genotyping during the patients’ routine clinical examination. This will potentially facilitate faster decision-making on determining their potential suitability for AstraZeneca’s genomically targeted medicines. The development of the test underscores QGEN’s expertise in CDx commercialization, utilizing the most suitable molecular testing platform to meet the specific clinical and commercial needs of patient testing.

The QIAstat-Dx system is designed for laboratory use and employs cost-efficient, single-use cartridges with built-in sample processing and on-board reagents. Utilizing multiplex real-time Polymerase Chain Reaction (“PCR”), the system detects and differentiates between multiple biomarkers, providing results in about an hour. It also provides easy-to-view cycle threshold (Ct) values and amplification curves, offering additional insights not available with end-point PCR or other techniques. Per QIAGEN, more than 4,000 cumulative instrument placements had been made at the end of 2023. 

QIAGEN’s Growing CDx Collaborations

As a prominent player in precision medicine, QIAGEN collaborates with pharmaceutical and biotechnology companies to develop CDx that detects genetic abnormalities, providing insights that guide clinical decision-making about treatments. The company offers a wide range of technologies, from PCR and digital PCR (dPCR) to next-generation sequencing (NGS), allowing for tailored products to meet partners’ needs.

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With more than 30 master collaboration agreements, QIAGEN boasts a deep pipeline in advancing precision medicine, tailoring treatments based on the genetic profiles of patients identified through CDx testing. Its new agreement expands collaboration with AstraZeneca beyond oncology, including complex chronic diseases.  Additionally, QIAGEN has a series of collaborations with Neuron23 and Helix to develop CDx in disease areas outside oncology.

Prospects in the CDx Market for QGEN

A report by Roots Analysis values the global CDx development market at $0.57 billion in 2024 and forecasts it to rise at a compound annual growth rate (CAGR) of 11% by 2035.

Over the years, the CDx tests have become increasingly important as they serve multiple functions, such as identifying individuals most likely to benefit from a specific therapeutic product, detecting those at higher risks for severe side effects and tracking treatment responses to optimize safety and effectiveness. The growth in the industry over the next decade is likely to come from the increasing demand for personalized treatment, the report cites.

Other Developments in QIAGEN’s Molecular Diagnostics Wing

In June 2024, QIAGEN launched the QIAstat-Dx Gastrointestinal Panel 2 in the United States, following its approval by the FDA for use in clinical settings. The new panel expands the company’s U.S. menu for syndromic testing, building on the use of the QIAstat-Dx Respiratory Panel Plus that can identify 21 pathogens causing respiratory infections from viral and bacterial pathogens. Both Panels are cost-efficient, single-use cartridges that fit easily into the QIAstat-Dx Analyzer 1.0.

QGEN Stock Price Performance

In the past year, shares of QGEN have dropped 2.6% compared with the industry’s 2.3% fall.

QIAGEN’s EPS Surprise History

QGEN’s historical five-year earnings growth rate of 8.3% is well above the industry’s 0.9% growth. In the trailing four quarters, the company surpassed earnings estimates thrice and missed on one occasion, the average surprise being 7.2%.

QGEN’s Zacks Rank & Top MedTech Stocks

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

Some better-ranked stocks in the broader medical space are Exact Sciences (EXAS - Free Report) and AxoGen (AXGN - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.

Exact Sciences’ shares have declined 25.6% in the past year. Estimates for the company’s loss per share have improved from $1.09 to 95 cents in 2024 and from 26 cents to 6 cents in 2025 in the past 30 days. EXAS’ earnings beat estimates in three of the trailing four quarters and matched in one, delivering an average surprise of 56.2%. In the last reported quarter, it posted an earnings surprise of 75.7%.

Estimates for AxoGen’s 2024 loss per share have narrowed to 1 cent from 19 cents in the past 30 days. Shares of the company have surged 107.5% in the past year compared with the industry’s growth of 9.9%. AXGN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%.


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