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Qiagen Cites Competitive Advantages in Digital PCR, Sequencing Assays as Part of Core Growth Plan


NEW YORK – Qiagen is positioning itself to be competitive in the digital PCR and sequencing spaces as it continues to focus on driving future growth in its core product portfolio.

On a call with investors Tuesday morning following the Monday release of Qiagen's third quarter earnings, company executives offered updates on the firm's broad portfolio, noting that its legacy sample preparation business is also enhancing its newer offerings.

On the call, Qiagen CEO Thierry Bernard said that Q3 marked the seventh consecutive quarter of double-digit growth at constant exchange rates for the firm's non-COVID portfolio.

Qiagen began placing its QIAcuity digital PCR systems in 2020. The system is a single nanoplate-based instrument, offering three different workflows that can provide more customized throughputs.

Currently, digital PCR systems are available from Bio-Rad Laboratories, Stilla Technologies, Thermo Fisher Scientific, and Roche. Bio-Rad in particular has described intentions to increase its focus on the biopharma space, where digital PCR can be used for quality control, purity, and safety testing.

Bernard said Qiagen has recently launched 13 new biopharma assays on the QIAcuity system for "key application areas" of cell and gene therapies. "This is an extremely important step in our entry into the biopharma area of the market, which we see as important customer segment involving pharma companies around the world," Bernard said. "It creates a strong base for future growth in 2023," he added.

Bernard further noted that the entrance of Roche into the digital PCR space earlier this year "proves once again that this market is dynamic — we believe that Roche will help us in growing the interest of customers in digital PCR."

Finally, he noted that the QIAcuity system is a single instrument, while the new Roche system is two components, and thus not fully integrated. "I never criticize competition, but I still believe given its specificities, QIAcuity is well placed to take a leading position in this market," Bernard said.

Overall, Qiagen sees a $350 million to $400 million digital PCR market opportunity, he said, in the context of a total addressable market for qPCR of $3 billion.

On the genomics and next-generation sequencing front, Qiagen launched a "platform-agnostic" approach in 2019. Bernard said Qiagen's assays and bioinformatics are universal and can be used on any sequencing platform including those from Illumina, Thermo Fisher Scientific, Element Biosciences, and BGI.

Although the genomics market is showing signs of slowing with the tapering of the pandemic and other macro trends, Qiagen expects its platform-agnostic approach to be "less exposed," Bernard noted, since it is not involved in platform sales.

That said, the business only had single-digit growth in the quarter, which the firm attributed to a tough comparison to Q3 last year, which had increased sales due to customers coming back to routine NGS testing combined with government investment into SARS-CoV-2 virus sequencing.

In general, Qiagen was hit somewhat earlier than others by supply chain constraints during the pandemic. As a consequence, the firm claims that it has gained valuable insights that are helping it avoid some of the issues with supply of parts, reagents, and shipping costs that are still plaguing the industry.

"Our supply and purchasing team is extremely prepared and extremely on the ball for more than two years now," Bernard said. For example, the firm is not hesitating to agree to one-year commitments with suppliers, and is carrying an increased inventory on semifinished goods, which has helped to lower shipping and related logistics challenges.

Bernard also said Qiagen's back order level was back to pre-COVID levels, while its sample prep technologies business is "benefiting from a new wave of instrument upgrades."

The firm is now combining the various arms of its portfolio in new ways, as well, Bernard said.

For example, it is combining its EZ2 Connect nucleic acid purification instrument with QIAcuity digital PCR to enable a liquid biopsy testing workflow.

"This workflow combines the key features of these two platforms … in order to handle the demands of high-volume liquid biopsy samples," Bernard said. "This unique 'power of two' offers optimized detection and quantification for successful biomarker profiling," he also said, adding that it can be used on all liquid biopsy analytes, including circulating tumor DNA, cell-free DNA, and exosomes.

On the call, the firm also offered updates on its NeuMoDx system, QuantiFeron latent TB business, and QIAstat-Dx syndromic testing system.

Specifically, it launched two new CE marked assays for NeuMoDx in the quarter for transplant diagnostics, bringing the CE-IVD menu to 16 tests. The firm also certified the NeuMoDx platform under the new EU medical devices regulations.

However, the timeline for US commercialization was delayed by having launched during the pandemic, Bernard said. That said, it is the only system with random-access LDT and regulated tests in the US. "This is unique, and this is why we can continue to sell in the US even if we have less menu than in Europe."

The QuantiFeron business had 14 percent growth year over year in Q3 due to higher TB rates globally, and Bernard said year-to-date growth is well above the firm's target of $310 million in 2022.

However, Qiagen previously partnered with Ellume to develop a low-cost test called QIAreach for high-burden, low-income countries, and that company has since entered insolvency proceedings.

"We remain extremely committed to bringing TB testing solutions to as many countries around the world as possible," Bernard said. Qiagen is working on new options for the product, and is also open to new solutions, he added, noting that the QIAreach sales contribution has no impact on near-term growth plans.

For the QIAstat system, the firm's meningitis panel received the CE IVD mark, and Qiagen has also launched a viral vesicular syndromic panel to detect monkeypox and related infections.

"Placements are beginning to grow worldwide, and it is worth noting that more than 50 percent of sales for QIAstat are now for non-COVID applications," Bernard said.

The monkeypox test in particular "is another example of the flexibility we have with the QIAstat diagnostic system, and the growing use for syndromic testing," Bernard said.

The firm has submitted its gastrointestinal syndromic panel to the US Food and Drug Administration and expects a decision in 2023. It will also submit its meningitis/encephalitis panel next year to the FDA, Bernard said. The firm's respiratory panel is currently offered in the US, and all three are QIAstat assays that are CE-IVD marked.

Qiagen is also seeing solid trends for QIAstat diagnostic module placements, as well as interest in Europe for the high-throughput QIAstat Rise system, Bernard said.