NEW YORK – Qiagen debuted its QiAcuityDx digital PCR system for clinical end users on Monday as it continues to build an initial regulated assay menu focused on oncohematology and companion diagnostics.
The firm has also obtained CE-IVDR marking for the QiAcuityDx and has registered the system with the US Food and Drug Administration.
Now, "we're taking orders," said Jonathan Arnold, VP and head of translational science and precision diagnostics at Qiagen.
Qiagen expects to submit the QiAcuityDx system to the FDA for 510(k) clearance along with an assay to detect BCR-ABL fusion genes in the second half of 2025.
The detection of BCR-ABL fusions is used to confirm diagnoses of chronic myeloid leukemia. The testing is also used to monitor patient responses to therapy and determine when to stop treatment.
And, in clinical oncology in general, Arnold said that clinicians are increasingly adopting dPCR for its enhanced precision compared to qPCR.
"Anecdotally, we're beginning to see that they won't even remove a patient from therapy unless there's a digital PCR result," he said.
The QiAcuityDx system has been in development at Qiagen for roughly three and half years, according to Arnold.
Like the company's QiAcuity research system, QiAcuityDx uses Qiagen's nanoplate-based droplet partitioning approach.
This allowed Qiagen to build an integrated system that "is essentially load-and-go," Arnold said, integrating droplet partitioning, thermal cycling, and detection into one instrument.
The system can process four nanoplates simultaneously, with continuous sample loading allowing it to take on stat testing.
While some newer commercially available PCR systems have six, or even seven, optical channels, the QiAcuityDx has five. Arnold noted, however, that the firm could potentially increase multiplexing with different chemistry approaches and also said that five channels is sufficient for clinical oncology lab applications.
Wim Trypsteen, a medical genetics researcher and co-coordinator of the Ghent University Digital PCR Center, agreed that while five colors is a bit less compared with other platforms, "In my opinion it still suits the needs of the current user, especially in an IVD setting." However, there may be a need to increase the number of channels, he said, if 20- to 40-plex clinical assays become more routinely available, which may happen in the coming years.
For the clinical space, Qiagen also designed the QiAcuityDx to be operable in a regulated IVD mode as well as an open, assay-development mode that can be used for laboratory-developed tests.
The IVD mode offers validated assay plug-ins and automated analysis, while the so-called utility mode can provide flexibility for research applications or assay development. And, in the open mode, QiAcuityDx users can access Qiagen's portfolio of research-use products and applications — including more than 100 QiAcuity assays launched earlier this month — through its GeneGlobe platform.
The software for the QiAcuityDx was also created for diagnostic purposes, the firm said in a statement on Monday, and features "a user-friendly interface and comprehensive audit trail compliant with modern lab requirements."
Other features intended to appeal to clinical lab end users include bidirectional laboratory information management system (LIMS) interfacing, universal master mix manufactured under strict regulatory standards, and safeguards to reduce cross-contamination.
Other dPCR systems vying for the clinical space include the Bio-Rad Laboratories QXDx, Stilla Nio+, Thermo Fisher Scientific Absolute Q, and Roche Digital LightCycler.
The Bio-Rad Laboratories QXDx was launched with an IVD mode and open mode, as was the Roche Digital LightCycler, and end users in the overall clinical PCR space reportedly appreciate having a single instrument that deploys this particular strategy.
Qiagen, however, also hopes end users will appreciate the advantages of the QiAcuityDx compared to next-generation sequencing.
"The first time to result is a little over two hours, which is a big differentiator for digital PCR versus NGS," Arnold said. "We think about digital PCR as a nice complement to NGS … for applications where you actually need to monitor results over time," he added.
Part of Qiagen's approach to driving dPCR uptake in clinical labs involves market development and clinician and laboratorian education, Arnold said, particularly around the use cases for dPCR as compared to qPCR or NGS.
"That's a big piece of what we're doing, and we get a lot of traction from webinars as well as from engaging with key opinion leaders and having a strong publication strategy," he said.
Trypsteen noted that this approach is also a trend in the overall market. "As digital PCR is increasingly being used, platform providers are also trying to further understand what the needs of the customers are and launching training videos, expert talks, et cetera to get a community vibe going, [which is] something that we only can be happy about," he said.
Qiagen is now targeting oncohematology, in part based on the fit with its Ipsogen qPCR assay business in the blood cancer space, Arnold said. The firm also plans to add to its QiAcuityDx assay menu through collaboration with other developers.
An assay called BCR-ABL %IS from Bio-Rad Laboratories will be the predicate for the QiAcuityDx BCR-ABL test 510(k) submission.
The Bio-Rad BCR-ABL test was granted de novo authorization in 2019 after getting the CE mark two years earlier. At the time, Bio-Rad also said that it would expand its Droplet Digital PCR oncology menu and also expand digital PCR into other regulated testing in collaboration with other developers.
Colin Lindsay, a medical oncologist at the Christie NHS Foundation Trust in Manchester, UK, said in an email that he has tested out the QiAcuityDx on retrospective blood samples taken from patients with stage IV lung cancer.
"Our aim is to optimize its potential as a highly sensitive method for detecting driver and resistance mutations in oncogene-addicted disease," Lindsay said, adding, "This will allow us to assess patient outcomes in real time during treatment, in turn finding new settings for designing clinical trials where interventions can be introduced at the first sign of resistance."
To Lindsay, one exciting aspect of using newer, more sensitive technologies like dPCR is that they can challenge the underlying assumptions in the clinic.
"We are still unsure whether resistance mutations that develop during treatment are genuinely new," he said. "They could be present at diagnosis but beyond the limits of detection with existing technology," Lindsay noted, so answering this question with digital PCR systems like the QiAcuityDx "could help change our understanding of resistance and how we approach it with targeted treatments in particular."
Qiagen has also set its sights on companion diagnostic development with the QiAcuityDx.
Digital PCR is a key technology for the clinical requirements of pharma, Arnold said.
"Pharmaceutical companies are embracing it," he said. "We have several projects running and a very good pipeline that really shows the clinical benefit of dPCR … [and] companion diagnostic development is a centerpiece of our content strategy."
So far, the firm has signed three partnerships with undisclosed pharmaceutical companies to date, Arnold said, to advance dPCR into precision medicine.
Qiagen is currently focused on marketing the QiAcuityDx in the US and Europe, but the system is available globally. It will be priced competitively, Arnold said, at around $130,000.
The firm noted at an investor event in June that it has placed more than 2,000 of its QiAcuity research systems since launching the platform in 2020, and it aims to triple its overall QiAcuity dPCR business from $90 million in sales in 2023 to $250 million in 2028.