NEW YORK – With two new instrument launches planned in the US this year, Roche is continuing to broaden its molecular diagnostic offerings.
One key move Roche is making this year is a foray into the digital PCR market with its Digital LightCycler. Still "a very new technology" to laboratories, digital PCR allows for absolute nucleic acid quantification and superior sensitivity, Miriam Fend, Roche's life cycle leader for PCR system, noted.
Because the technology remains novel, the digital PCR space is an open market for Roche to slot into with major players in the space including Thermo Fisher Scientific, with its QuantStudio Absolute Q Digital PCR System, Qiagen and its QIAcuity digital PCR system, Stilla Technologies with the Naica system, and Bio-Rad Laboratories and its QX digital PCR line of instruments. According to Fend, Roche is looking to bring a "competitive system" into the marketplace.
The firm wants to make digital PCR accessible for both clinical research and laboratory developed tests, Fend said, and use the digital LightCycler to complement the company's "strong" qPCR offerings.
Roche is looking to launch the Digital LightCycler with "high-precision assays" in infectious disease and oncology, Fend said. Cindy Perettie, head of molecular labs at Roche, added that the sensitivity of digital PCR allows Roche to grow its portfolio for more specific testing needs and provide "more comprehensive offerings" to its customers. She also said the firm plans to launch the Digital LightCycler in "select markets worldwide" by the third quarter of 2022.
Fend noted that the instrument would be a "great option" for applications such as treatment monitoring in oncology, environmental surveillance for infectious diseases, and donor-derived transplant rejection monitoring.
The platform consists of two instruments: a partition engine and an analyzer. Samples are placed in the partition plates — it uses a three-plate configuration with 20,000, 28,000, and 100,000 partitions — and then loaded in the partition engine. Once the partition is finished, the plates are loaded into the analyzer, where every partition undergoes an independent PCR reaction — depending on the number of plates, the process takes between an hour and a half to nearly four hours.
The instrument also includes six optical channels, which Fend said "substantially increases the capacity for multiplexing with consistent results across the whole dynamic range." The instrument can run between eight and 96 samples, she added.
Roche is targeting clinical labs and clinical research settings for the Digital LightCycler, the same settings it has targeted with the current LightCycler instruments and the Cobas machines. Roche looks at molecular testing as an ecosystem "where different technologies and different settings complement each other," Fend said, adding, "We think there's a lot of synergies in what we can now offer" with each of Roche's instruments, since they're not competing technologies but rather complementary.
The firm can also leverage its connections with existing customers that are familiar with the rest of Roche's PCR and next-generation sequencing instruments, Perettie said.
Although Fend said it's too early to comment on what the demand for the instrument will be, Perettie said that while investigating the space, the firm saw that "there is a market" and that people are interested in the digital aspect. "This is a nice next-generation opportunity that we're going to be able to offer a lot of labs," she said.
Strategically, Roche has been working to "provide comprehensive solutions" for all DNA testing needs, whether with PCR or sequencing, Fend said, and entering the digital PCR market is just another step toward that strategic goal. Particularly as digital PCR technology is evolving from research use to clinical lab use, the firm's "ambition is to help [digital PCR] users to make the leap between prototyping to viable clinical solutions," Perettie said.
At launch, Roche will be putting the Digital LightCycler on the market with "exclusive consumables," Perettie said. It is also exploring comarketing agreements with oligomer manufacturers to facilitate "the creation of custom-designed assays." The firm also plans to use its acquisition of TIB Molbiol, which it completed in December, to offer off-the-shelf assays, she said.
Tying into Roche's overarching strategy, Perettie said that when thinking more broadly about where labs are going in a post-COVID-19 world, there is a "meaningful move toward efficiency." Part of that move includes automation, which has become a big selling point in many labs — one that Roche is trying to meet. "The goal would be that we'd be able to see more patients being tested in a single laboratory," thanks to this automation, Perettie said.
There is also a trend toward decentralization, as instruments and tests that were only prevalent at large labs in developed countries are now found in small hospitals and in countries that didn't have access to this type of testing, Fend emphasized.
Further PCR launch
Another new product, the firm's Cobas 5800 instrument — a lower volume version of its Cobas 6800 and 8800 machines — launched in Europe late last year and is expected to launch in the US in the second half of 2022, Fend said.
Fend noted that the launch of the Cobas 5800 is an attempt to complement the company's "strong" high-throughput solutions, as there is a "need to have more nimble and flexible solutions that can go into … smaller laboratories." Cobas 5800, she said, is part of a "long-term vision" to expand Roche's reach into lower-volume labs and broaden access to diagnostic testing globally.
The Cobas 5800, which received CE marking in November and has been submitted to the US Food and Drug Administration for approval, will have the same test menu as the 6800 and 8800 instruments with the same quality, just with a much smaller footprint, Fend said. Instead of running up to 400 samples in an eight-hour shift, as with the high-throughput machines, the Cobas 5800 can run up to 144 samples in the same time frame. Like the other instruments, it is fully automated and can run up to six different types of samples, including nasal and nasopharyngeal swabs, blood, and urine, Fend said.
So far, Roche has received CE marking for six Cobas tests on the new instrument, including a multiplex SARS-CoV-2 and influenza test, a qualitative HIV-1/HIV-2 test, and hepatitis B and C tests. The rest of the tests currently available on the Cobas 6800 and 8800 instruments will be available on Cobas 5800 during a second wave of launches, Perettie said. Some of the tests currently in development for Cobas 5800 are for human papillomavirus, chlamydia and gonorrhea, tuberculosis, and cytomegalovirus, according to Roche's website.
While the Cobas 5800 is suitable for labs in smaller hospitals, Fend noted that it could also be used as a complement in larger labs that also have a 6800 or 8800 machine, or in hospitals or health systems that use a "hub and spoke" model with a large central lab and smaller hospital labs. The training is the same across the Cobas systems, so the same staff can run any of the instruments, she said. Multiple tests can be combined simultaneously onto the instrument, Fend said, which helps when serving a community with diverse testing needs.
Perettie added that the Cobas 5800 could also be used in countries with fewer resources and less access to central laboratories. It "hits that sweet spot" between a high-volume instrument and a point-of-care instrument, she said.
Although both Perettie and Fend declined to specify the price point for the instrument, Perettie said the company has a focus on "sustainability" with pricing to make sure it's affordable globally. She added that it was too early to disclose sales figures or placement numbers for the machine.
Regardless of where they're used, Roche's new instrument launches are intended to work in tandem with each other, both Perettie and Fend noted. "We want to have a family approach where we have something for everybody around the globe," Perettie said.