By Kirell Lakhman

Quest and 3M’s plan to launch a bench-top real-time PCR instrument that eliminates the need to independently extract and purify nucleic acid is an “exciting” proposition for several clinical lab directors whom I spoke with this week.

But the companies will likely have to wait some time before the platform, which was developed by 3M, gains traction in the market.

Quest subsidiary Focus Diagnostics is already marketing a first-run version of the instrument that does not include integrated DNA or RNA extraction to high-complexity CLIA hospital labs. At the moment there’s just one test that can run on it: a Quest H1N1 assay that has been granted emergency use authorization from FDA.

Quest has said the so-called 3M Integrated Cycler, which costs less than $75,000 and will eventually be marketed to moderate-complexity labs, will help it fulfill its goal of shifting flu and other respiratory-virus testing “away from the reference lab and into hospital labs,” according to Sample sister publication GenomeWeb Daily News.

According to Quest, the principal benefits of the current version are its size and speed: It weighs 15 lbs, is about the size of a counter-top bread maker, and can process up to 96 samples per run in 30-75 minutes.

An updated version, which Quest and 3M said will debut in the “medium term,” will offer integrated nucleic acid extraction and purification. And even if such an integrated instrument, at least on paper, could streamline a clinical lab’s workflow and save gobs of cash, most labs said they will remain on the sidelines until additional tests become available. (Quest said it expects to debut other assays in 2010, which would be sold under the brand name Simplexa, though didn’t say what respiratory indications they may target.)

"We fully expect that as we fill out the Simplexa line, there will be additional assays that might be more traditionally considered infectious disease with respect to hospital-acquired infections," according to David Whitman, senior lab manager for 3M's Infection Prevention business, which developed the instrument.

According to a Quest spokesperson, the cost of the current version of the Integrated Cycler is "in line with the costs of competing molecular platforms." Labs would still be required to shell out for sample prep and other supplies to perform the test, including the $50 Quest charges for the H1N1 kit.

To get a feel for the kind of customers Focus will face when it starts shopping the instrument around, I asked a dozen or so lab directors whether they would consider buying one.

Fresh Air for Respiratory Testing?

An integrated platform “is always very attractive conceptually” to lab directors, according to Keith Jerome, director of Diagnostic Molecular Virology at the Fred Hutchinson Cancer Research Center in Seattle.

“We’ve been interested in that sort of stuff for a while … and have been hoping that kind of [technology] will come [to the Hutch] because we’re interested in the end-to-end costs of the process of testing,” he told me. “To have these costs rolled into one small instrument is super.”

Jerome’s lab, which is part of the University of Washington’s Vaccine and Infectious Disease Institute, is a big facility — around 10 med techs perform 35,000 clinical samples each year — and the under-$75,000 cost of the 3M platform “doesn’t necessarily scare us off,” he said. “But it needs to do more than one test.”

But if the platform “suddenly becomes robust … and can do an entire panel of respiratory viruses or enteroviruses or hepatitis viruses, then it becomes very attractive because something like this can really change the way we work and could bring us much more in line” with what other facilities, like chemistry labs, can do, he said.

“We can decrease the turn-around time and presumably increase productivity — though I’d really have to study the throughput of the instrument — but in a general sense this is the direction in which the field is going to go,” Jerome added.

Greg Tsongalis, director of Molecular Pathology at Dartmouth Medical School’s Hitchcock Medical Center in New Hampshire, agreed, saying “the potential to have a completely integrated real-time PCR instrument is an exciting proposition.”

“Most companies are now working on such devices as they realize the next biggest market are hospital labs without a lot of experience,” he said, but added that he “would have to see how it matched up to its competitors with respect to cost, performance, and test menu before deciding.”

Others suggested the instrument could be a double-edged sword: Though the idea of an integrated instrument is swell, Quest’s decision to make it a closed platform would force labs to make a significant capital expenditure on the new platform — not to mention make space on a congested bench for the instrument — if they want to offer tests designed to run exclusively on the platform.

Though Quest already offers an EUA H1N1 assay than can run on real-time PCR platforms made by ABI and Roche, additional Simplexa tests may be designed to work only on the Integrated Cycler (something Quest investors will no doubt hope for). With this in mind, some lab directors could choose to sit on the sidelines and hope for another real-time PCR maker to debut a similarly “integrated” platform that can run tests that the lab currently offers.

This scenario could also be a double-edged sword for Quest and 3M: According to the Hutch’s Jerome, although Quest and 3M appear to be “way out in front of a wave that is coming, the people at the very front don’t always win these things.”

That doesn’t mean he’s not enthused by the prospect. “These sorts of systems are slowly going to replace the dedicated real-time PCR instruments [and] the dedicated extraction instruments that we [currently] link up in an ad-hoc way,” he said. “I can see a situation where the majority of the routine testing would be done by eight or 10 of these [3M] platforms lined up in a lab,” and that the Integrated Cycler could “augment what lab techs are able to accomplish. It could become a part of everybody’s work day.”

Indeed, he said he can see such an instrument do “most of” the 35,000 samples his lab runs each year. “There could be tremendous volume for this kind of thing.”

Jerome said his lab will “probably wait until the dust settles” on the current H1N1 maelstrom before seeking additional information on 3M’s new platform. “We would definitely be interested [in the instrument] if the [end-to-end] price was right.”

He told me “the most likely” way he will dip his toes into the 3M platform is by buying “a couple of them” and testing them on assays that “require a fast turnaround and that don’t have a tremendous volume of demand each day,” such as pediatric enterovirus infections. He also said influenza would be “a fine choice, if only we had time to do it.”