NEW YORK (GenomeWeb) – Beckman Coulter continues to develop the test menu for its CE-marked real-time PCR molecular diagnostics platform, the DxN Veris, but anticipates it will take a few years yet to bring to the US market.
The company provided GenomeWeb with an update on the platform at the American Association of Clinical Chemistry annual meeting and lab expo last week in Atlanta.
"We've just launched it in Europe with four viral load assays: HIV, hepatitis B virus, hepatitis C virus, and cytomegalovirus," Richard Creager, senior vice president of molecular diagnostics and CSO of Beckman Coulter Diagnostics, told GenomeWeb.
The next wave of assays in development are for sexually transmitted diseases — chlamydia, gonorrhea, trichomonas, and human papillomavirus — and for hospital-acquired infections. For HAIs, the pipeline includes an assay for methicillin-resistant Staphylococcus aureus (MRSA), followed by one for Clostridium difficile, Creager said.
Furthermore, a collaboration with Seegene will enable some of these assays to simultaneously test for multiple targets.
"Veris was designed with the ability to do real-time PCR, but it also can do melt analysis; we're using Seegene's newer melt analysis technology to do multiplex assays," Creager explained.
For example, the HPV panel will likely include many more of the oncotype strains than other commercially available tests, he said.
"We're also working with Seegene [to develop] a large multiplex respiratory virus panel," Creager said.
The European launch includes assays for viral load, and "no other company can perform all four viral load assays on one platform at the same time," Creager asserted.
He explained that the firm chose not to officially launch until all four assays were ready because the company believes platforms should be launched with menus around areas where labs tend to focus, instead of with single assays. The viral load menu is thus part of an overall philosophy to consolidate workflow to make the lab more productive.
Beckman Coulter will follow a similar approach in the US, Creager said.
However, the viral load tests would require pre-market approval submissions to the US Food and Drug Administration, and launching PMAs first is "a higher-risk regulatory strategy," he said.
The firm will therefore seek 510(k) approval for the STD and HAI assays and launch DxN Veris with those. "Then we'll follow that up with our PMAs for the four viral load assays," Creager said.
The US launch is still a couple of years away, but in the meantime the firm is taking the current product to other markets throughout the world.
So far there has been very positive feedback, Creager said, noting that Beckman's platform offers something that most of its competitors don't: true random access capabilities, as opposed to other systems that Creager said could more accurately called "random batch." Often such systems require laboratorians to accrue a certain number of samples before it is economically feasible to run assays, leading some labs to schedule tests for different agents on different days.
"They might run HIV Monday, Wednesday, Friday, and HCV on Tuesday and Thursday; CMV may be a lower volume so they will run it one day a week," Creager said. "With DxN Veris they don't have to do that anymore — you get one HBV or CMV, you run it, and the economics are the same."
This is enabled by the system's "load and go" design, allowing researchers to add samples in a continuous manner.
It also uses fewer consumables than its competitors, Creager said. It runs using only four components: the sample, an extraction cartridge, an assay reagent cartridge, and pipette tips. And the platform is designed to hold up to 20 assays on board at a time.
"On Veris, assay reagents are refrigerated so customers can keep them on the instrument … once they've been opened they're good for 14 days on the system," Creager added.
The continuous operation design was also intended to enable to firm to add the DxN Veris to its larger automation track in the future, Creager said.
Although the DxN Veris was not on display at AACC, the firm has been demonstrating it at conferences in Europe, such as EuroMedLab and the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
Over the past two years the firm has also presented a number of posters describing the platform and viral load assays.
Specifically, it has presented six assessments of its cytomegalovirus assay, performed by labs in house as well as at universities in the US and Europe. It has also presented three studies of the HBV assay, two of the HCV assay, one of the HIV assay, as well as a crossover contamination study.
These assessments demonstrate high sensitivity and specificity using spiked-in samples and patient samples. Furthermore, the studies typically compare the assays and platform to ones from other firms, such as Roche and Qiagen, showing comparable results.
Additionally, Beckman Coulter recently completed four independent studies done by a third party, Creager noted. "They went in and did workflow analysis in three or four labs, and they looked at whatever products they were currently using versus DxN Veris," he said, noting they examined factors like ease of use and time to first result. "In general we soundly beat the competition in every category."