AMSTERDAM (GenomeWeb) – The decision by Siemens Healthcare Diagnostics to integrate a Thermo Fisher Scientific real-time PCR platform into its Versant kPCR molecular diagnostics workflow, announced last week, is the latest in several planned strategic initiatives by Siemens to re-establish itself as a serious player in the molecular diagnostics arena, company executives said this week.
Speaking on the sidelines of the European Congress of Clinical Microbiology and Infectious Diseases held here this week, Fernando Beils, head of molecular diagnostics for Siemens Healthcare, and Joern Mosner, head of R&D for molecular diagnostics at Siemens Healthcare, told GenomeWeb that Siemens and Thermo Fisher will now work together to pursue US Food and Drug Administration clearance for the workflow.
Ultimately, Siemens hopes to carve out a customer niche that it thinks will benefit from the specific clinical workflow advantages it can offer — namely, medium hospital labs and smaller reference labs that desire the flexibility to run both lab-developed tests and CE marked or FDA-cleared assays with a moderate degree of multiplexing.
"Right now we have strong competitors already on the market [in] Abbott and Roche," Beils said. "And we want to provide value that right now [is not available] on the market … [and] take advantage of the clinical workflow."
Siemens' current Versant kPCR (the "k" stands for kinetic, i.e. real-time PCR) system comprises two components: Siemens' benchtop sample prep module that is capable of automatically extracting DNA and RNA from multiple sample types in a 96-well format; and a thermal cycler, heretofore an Agilent platform.
A key feature of the system is also its MiPLX software, which Mosner described as a "flexible software solution" that enables easy setup of multiple assays per sample. "For example ... you can divide up the eluate into six wells and run up to six different assays with one patient sample," Mosner said.
By the end of this year, Siemens will replace the Agilent thermal cycler in its Versant kPCR workflow with Thermo Fisher's QuantStudio 5, one of the most state-of-the-art qPCR platforms offered by that company, and one that dovetails nicely with the MiPLX software, according to Beils and Mosner.
"There was a very good understanding between [Siemens and Thermo Fisher] of what we wanted to achieve," Beils said. "First of all we wanted to have the customization aspect for the MiPLX solution" — not coincidentally, the QS 5 features VeriFlex technology for six independent PCR temperature zones and OptiFlex technology with six decoupled optical detection channels.
"What's really attractive is that you can run six different thermal profiles on the system, so it offers lots of flexibility for our customers when they want to test different parameters," Beils said.
In addition, "We needed a thermal cycler that was [a] sign of our times, that means you have a touch screen, it's cloud-compatible, [has] several USB connection options, [laboratory information systems] connectivity, and can run through Bluetooth wireless," Beils said.
A conspicuous difference between Siemens' new MDx workflow and that of potential competitors such as Roche or Hologic, for instance, is the fact that the entire workflow is not integrated into one box, i.e. the Versant sample prep instrument and QS 5 will sit on the bench in different places in the lab. Beils and Mosner said that the company believes this to be an advantage when considering the market segment it plans to tackle.
"When we looked at the high-throughput labs, it was clear we will not participate here," Beils said. "This market belongs to other players. But you have the segment of some larger hospitals, and potentially also some reference labs, where they need the customization piece, [and] have certain LDTs alongside IVDs, and [want to] combine them."
Mosner added that "almost all customers buy IVD-cleared assays, but they still have their own assays, and would like to continue to use these assays. Also, in the PCR world, you always underestimate the contamination issue. Customers like to separate the sample prep piece from the detection piece. We offer this. This might not be as relevant if you have a cartridge-based system, but that's also more expensive."
The current test menu for the Versant kPCR system currently includes CE-marked quantitative assays for HIV-1, hepatitis B, and hepatitis C; combined Chlamydia trachomatis and Neisseria gonorrhoeae; and combined quantitative measurement of viruses important in transplant or immunocompromised patients.
The future test menu of the new workflow will likely feature some of these tests, but also new assays that take advantage of the specific clinical workflow — "it could be transplant [diagnostics], it could be gastro[intestinal], respiratory, potentially tropical [diseases]," Beils said. "We're currently having discussions with key opinion leaders as to what would be the best entry back into the market."
In fact, the company has already made a move in the tropical disease space, as last month it said it had developed a real-time PCR assay for Zika virus and intends to apply for Emergency Use Authorization in the US. Concurrently, it launched the Versant sample prep module alone in the US as a registered Class I device, allowing it to be used in an LDT workflow.
Beils and Mosner said that Siemens and Thermo Fisher will likely develop additional tests for the workflow together, but Siemens also plans to tap into third-party assay developers to quickly build out a menu.
Molecular diagnostics is just one piece of the clinical diagnostics puzzle at Siemens Healthcare Diagnostics. Beils declined to say how big of a piece, as the company does not disclose financial information to that degree, but noted that MDx is "seen as a strategic field for innovation and Siemens is investing heavily" in the area.
In general, the company has been in the process of re-shaping its entire in vitro diagnostics business, which has been in some disarray since about 2007, when it acquired three companies: Diagnostic Products Corporation, Dade-Behring, and Bayer Healthcare Diagnostics, from which it inherited the bulk of its qPCR business.
"Basically Siemens had a major task to integrate three giants in immunoassays and clinical chemistry, and all the other adjacent territories like hematology [and] microbiology, and we've been pretty busy all these years to really focus the portfolio," Beils said. "We uncovered certain items where we want to invest, like laboratory diagnostics, point of care, and of course molecular. We also sold our microbiology business to Beckman Coulter last year ... because we wanted to focus on MDx, where we believe the investments and market growth are. Key to this is of course PCR, and we said we have a good PCR solution and want to focus on this, and this is where we are today."