NEW YORK (GenomeWeb) – Clinical lab supply firm Streck has launched a second-generation version of its Philisa PCR platform and will debut the system at the American Society of Human Genetics annual meeting next week.
A first generation version of the instrument was launched four years ago and continues to be available.
The second generation Philisa is "the real-time version of that instrument," Chris Connelly, manager of Streck’s molecular division, told GenomeWeb.
The molecular division at Streck is about five years old and is rapidly expanding to put out instrumentation and products that put the firm's own "unique and valuable spin on molecular diagnostics," Connelly said.
The new Philisa platform is able to run "very traditional 40-cycle" qPCR reactions in about 20 minutes, he said, adding that in-house studies achieved this time using standard reaction buffers and assay set-ups.
The Philisa also combines a number of common thermal cycler attributes. Its footprint is relatively small — 12 inches deep, 24 inches wide, and 18 inches tall — and it has six-color capabilities, “so you can do multiplex PCR on up to six different fluorophores at the same time,” Connelly noted.
It is also Peltier-based and uses a thermal control algorithm to precisely control the increases and decreases in temperature.
Philisa's speed is enabled by a proprietary PCR tube which is designed to have an optically clear tip for fluorescence qPCR but also to be "moderately deformable," such that it hugs the well in the sample block.
"That's one of the ways in which we maintain tight thermal control, so we can get to temperatures in a PCR protocol at really rapid rates," Connelly explained.
The tube is also validated at volumes between 10 microliters and 50 microliters.
Interestingly, the 32-well instrument can function as a single thermal cycler, but the wells are segregated into four independent modules of eight wells each, and these modules can also function as four independent thermal cyclers.
"The nice advantage of that is, you can run multiple PCR protocols at the same time and they can have staggered start times, so if you have multiple users that wish to use it at the same time, that is an option for the lab," Connelly said.
Alternatively, samples requiring testing for multiple targets using different thermal cycling conditions could be aliquoted and tested using four different protocols simultaneously on the platform.
"We have application data where we have run a reverse-transcriptase PCR assay on the instrument and completed it in about 25 minutes, and done a multiplex PCR assay at the same time and completed that in 22 minutes, and we did duplicate assays at the same time to get our repeats in," said Connelly.
Comparing the four thermal cycler units also allows for validation of thermal uniformity and optical reproducibility. And the modular nature of the platform means that a user can pull out one unit and send it in for calibration if needed, while "the other three modules that are remaining are still functional on the instrument," he said.
The platform, which has a list price of $42,000, is targeted to the research lab market but could also be used in clinical labs.
"What we're trying to do is provide a very flexible solution that will add some value regardless of the lab you put it in; there are several research-use-only applications, and certainly a clinical lab could use the instrument to develop assays around the platform," Connelly said.
The software will guide new users from protocol set-up through to a run, but will also have advanced iterations for experienced users if they want to do more with data analysis.
"We know that, especially in clinical labs, you're going to have all different levels of expertise," he said.
The platform bridges some of the gaps between the closed systems and open systems that are currently on the market.
The concept is bit like the open, automated Elite InGenius from Elitech, which has 12 independent thermal cyclers, or possibly the BD Max from Becton Dickinson, which allows users to port in lab-developed tests, and it might be most similar to the Roche Liat in speed. Tetracore's portable T-Cor 8, meanwhile, is also modular and can run eight samples at a time using eight separate thermal cycling protocols, but it has four optical channels instead of six and requires longer reaction times.
In 2012, a company representative told GenomeWeb that Streck was considering entering the molecular diagnostics arena with the first generation Philisa instrument.
Connelly said the big push at the moment is "to support the field of antimicrobial resistance." This includes developing real-time PCR kits to detect the most prevalent genes associated with antibiotic resistance in gram-negative bacteria worldwide.
"These are all multiplex PCR-based kits, and if you use them on our instrument, the assays will also complete in that 20-minute PCR protocol time range," Connelly said.
A proof-of-principle study of the first generation instrument was published by Streck researchers last year in BMC Medical Genetics. That study demonstrated 15-minute, 30-cycle amplification of myotonic dystrophy type 1 allelic expansions from diluted whole blood when combining the Philisa with inhibitor-resistant reagents, in situ cell lysis, and hot-start polymerase.