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Focus Diagnostics Awaits CE Mark, FDA Clearance for Combined Flu/RSV Test on 3M Instrument


By Ben Butkus

Focus Diagnostics' next molecular diagnostic for the 3M Integrated Cycler will be a single test for seasonal influenza A, influenza B, and respiratory syncytial virus, a company executive said this week.

The test, which is expected to receive the European CE Mark in the next few weeks and has been submitted for regulatory approval in the US, would be the second under the company's Simplexa line of assays, established last year through an exclusive partnership inked between Focus and 3M.

In addition, Focus and 3M are currently developing a version of the influenza A/B/RSV test, as well as a test for herpes simplex virus, that would be suitable for use in moderate-complexity laboratories under the Clinical Laboratory Improvement Amendments act, the executive said.

In the meantime, the seasonal influenza A/B/RSV test, as well as the company's sole approved test for differentiating influenza A and H1N1 (2009) RNA, will be limited to CLIA high-complexity laboratories, Focus said.

The partnership between Focus, a wholly owned subsidiary of Quest Diagnostics, and 3M began in early 2009 when the companies signed an exclusive distribution agreement that would couple molecular diagnostic kits developed by Focus with 3M's Integrated Cycler platform under the Simplexa name and target customers at hospital laboratories.

Then, in October, Focus received an emergency use authorization from the US Food and Drug Administration for the first Simplexa test, for influenza A and H1N1 (2009).

Shortly thereafter, in an interview with PCR Insider sister newsletter GenomeWeb Daily News, Quest executives said that the company planned to launch additional test kits in 2010, and that its test menu would likely include additional respiratory viruses and infectious agents that affect certain sub-populations.

Since then, Focus and 3M have remained silent on the matter, although in May the FDA granted 510(k) clearance to the Simplexa Influenza A H1N1 (2009) test, making it the first molecular test for H1N1 flu to make the leap from an EUA test to full approval (PCR Insider, 5/25/10).

This week, Carl Stubbings, vice president of sales and marketing at Focus, told PCR Insider that the influenza A H1N1 510(k) approval highlighted the ability of Focus, via its parent company Quest, to "first of all bring the test into the laboratory, which no one had; and then commercialize the test so that other laboratories could perform it. I think it was a clear example of our ability to react nimbly to a particular situation. And we're going to keep trying to duplicate that as often as we can."

Stubbings also said that the May approval "highlighted the need for molecular testing in the respiratory area. Flu is obviously a big one, but then there are some other respiratory diseases like RSV that tend to occur in concert."

And, according to Stubbings, "current thinking is that H1N1 is now seasonal influenza … so the next test that we plan to launch will be a test for influenza A/B and respiratory syncytial virus."

Stubbings said that the test is currently pending a CE Mark in Europe, and has been registered in a number of other countries. "We've received the CE Mark, it's now just going through the bureaucratic process, and we should have the stamp in a week or so," Stubbings said. Once it receives this clearance, Focus would likely begin marketing the test soon thereafter.

Meantime, Focus has also submitted the test to the FDA for 510(k) clearance. "With our experience with H1N1, we've got what we regard to be a pretty impressive array of data," Stubbings said. "We're modestly confident that that should go through smoothly."

From there, in general, Focus will "continue to work on the respiratory test where it's appropriate, and a lot of that depends on what demand we see, and what movement we see in the market. That's where being a part of Quest is a significant advantage. We get a clear view of the direction in which the market is going."

However, as indicated last year in its interview with GWDN, Focus and Quest are also working with 3M to create Simplexa assays for the 3M Integrated Cycler to be able to run in moderate-complexity CLIA laboratories.

The current version of the Integrated Cycler is a benchtop instrument that measures about a foot on each side and weighs about 15 pounds, and can process up to 96 samples in a 30- to 75-minute run depending on the analyte.

The reduced footprint of the instrument is due to a disc-shaped consumable cartridge — as opposed to the more standard plate-based thermal cycler design — that promotes extremely fast heat transfer.

In order to make the platform suitable for moderate-complexity labs, however, Focus has done "some proprietary work here with the chemistry, and in conjunction with 3M's expertise in the microfluidic piece, that enabled us to do some things that you can't normally do," Stubbing said.

"The system is the same system," Stubbing continued. "We simply change the consumable, which is the rotor, to have a smaller number of tests per unit … and it enables the laboratory to run the whole thing from start to finish. It's literally sample to answer."

Stubbing added that Focus and 3M are working on validating the new version of the platform with "whatever the common sample type is, depending on the disease we're looking at," but that for the respiratory tests the sample would typically be a nasopharyngeal swab in transport media.

The influenza A/B/RSV test, assuming the current version achieves regulatory approval, will be the first in the Simplexa line to be rejiggered for moderate-complexity labs, although Stubbing did not provide a development timeline.

Following that, Focus is eyeing development of a "sample-to-answer" test for herpes simplex virus, with the primary medical need being that HSV often causes encephalitis in younger patients.

"The presentation there is a [cerebrospinal fluid] sample, usually from a child that is critically ill, and clinicians want to know very, very quickly whether they're dealing with viral encephalitis," Stubbing said. "So we see that sample-to-answer application there – you get a request for this, you get the CSF, you run the sample straight away, and you get an answer in 35 minutes or less.

"We've actually published some data on that particular test format, and that's the next one we'll be moving into the sample-to-answer format," he added.

And for the foreseeable future, the Simplexa assay line will be tied to the 3M Integrated Cycler, Stubbing said.

"We will only develop tests for that system, and they will only put our tests on that system," he said. "So it's a mutually exclusive deal. It goes back to the [original] partnership: they had a platform that lacked content; and we had the content and lacked the platform."