This article has been updated from a previous version to clarify pricing information provided by a Quest spokesperson.
NEW YORK (GenomeWeb News) – Industrial giant 3M has thrown its hat into the molecular diagnostics market with the shipment of its first thermal cycler — a compact microfluidics instrument called the 3M Integrated Cycler that Quest Diagnostics subsidiary Focus Diagnostics is marketing with a new line of tests targeted for infectious disease.
Quest is developing a family of assays specifically designed for the system that it is distributing under the Simplexa brand name. Earlier this month, Quest announced that its first assay for the system — the Simplexa Influenza A H1N1 (2009) test — had received emergency use authorization from the US Food and Drug Administration for use on the 3M Integrated Cycler. That followed an EUA that Quest was granted in July for an 2009 H1N1 test that runs on thermal cyclers from Roche and Life Technologies' Applied Biosystems business.
According to information provided by Quest, the four labs that perform its first EUA H1N1 assay on the Roche and ABI instruments tested more than 76,500 specimens for H1N1 between mid-May and Oct. 11, and these labs are currently performing nearly 11,000 tests per week. With the launch of the Simplexa product line, the company is now targeting a broader market for this type of testing — CLIA high-complexity hospital labs.
Jay Lieberman, medical director at Quest Diagnostics, told GenomeWeb Daily News that the partnership with 3M is in line with its goal to move testing for influenza and other respiratory viruses "away from the reference labs and into the hospital labs."
The 3M Integrated Cycler "has a number of features that make it potentially very attractive to hospital laboratories, and we think this could dramatically increase the ability of hospitals to do high-complexity molecular testing," Lieberman said.
In particular, Quest and 3M believe that the small footprint of the instrument — it measures about 12 inches on a side and weighs around 15 pounds — will appeal to hospital labs. The system can process up to 96 samples per run and provides results in 30 to 75 minutes.
A Quest spokesperson said that the approximate price to purchase the test kit is under $50 per test, though she noted that a lab would need to incur other costs not included in the test kit, such as sample preparation and other supplies, to perform the test. The 3M Integrated Cycler, meantime, is priced under $75,000, which the spokesperson said is "in line with the costs of competing molecular platforms."
The spokesperson added that Quest offers "financial options to facilities that do not have the capital to purchase the equipment," such as lease programs.
David Whitman, senior laboratory manager for 3M's Infection Prevention business, said that the company was able to reduce the amount of space required for the instrument without sacrificing throughput by relying on a "CD-style" centrifugal format as opposed to the plate-based design of most thermal cyclers. "Instead of relying on heat transfer into a large plate, we've got a very, almost infinitesimally small heat contact layer so that we have very rapid heat transfer," he said.
Quest's Lieberman noted that the new H1N1 test includes several improvements over the previous EUA H1N1 test designed for the Roche and ABI platforms. "We've improved the test itself over time, and we developed it specifically for this instrument, which has a number of advantages," he said. "It's got a faster run time, it's got a higher throughput, and more rapid results."
Lieberman said that the exclusive distribution agreement that it signed with 3M earlier this year provided a number of benefits for Quest. "We're not dependent on other manufacturers and them changing things and us having to adjust the assays," he said. "We have an instrument that in and of itself we think has advantages over certain other instruments, and we can tailor the assays to perform optimally on the instrument."
The H1N1 outbreak spurred Quest to release the H1N1 test as its first Simplexa product, but the company plans to launch additional test kits in 2010. Lieberman said that the firm will likely expand the menu to include additional respiratory viruses, as well as "other infectious agents or groups of diseases that affect certain populations," such as immunocompromised patients or transplant recipients.
Whitman said that 3M's Infection Prevention group has a particular interest in detecting and preventing healthcare-acquired infections. "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," he said, though he declined to specify any particular assays under development.
"This is a brand new area within the Infection Prevention division," Whitman said. "It's our first product in molecular diagnostics."
Longer term, Lieberman noted that Quest sees an opportunity for other types of molecular testing within the hospital labs that it is targeting for the Simplexa line. "We think that the laboratories around the country are increasingly going to be using molecular testing, not only for infectious diseases, obviously, but genetic diseases, cancer, and so on … More and more hospitals are acquiring those capabilities and we want to enhance their ability to do that sooner rather than later."
He stressed that the market for the Simplexa line is currently limited to CLIA high-complexity labs, but noted that Quest aims "to bring [the platform] down to moderate complexity so that more labs have the opportunity to do molecular testing."
The goal, he said, is "to be able to just get the sample, insert it in the instrument, and get an answer, rather than having to extract the DNA or RNA and go through various steps."
Whitman agreed, noting that in the "medium term," 3M expects to enable "full sample-to-answer capabilities on the current instrument design without any modifications."