By Kirell Lakhman
KISSIMMEE, Fla. ― Focus Diagnostics has placed at least one bench-top 3M Integrated Cycler real-time PCR platform at Cedars-Sinai Medical Center in Los Angeles, and has been “experiencing strong interest in diverse customer groups” throughout the US, Mexico, and Western and Central Europe, according to three people at Quest and its Focus Diagnostics business, which is marketing the tool.
The officials ― one of whom said Focus is “having a hard time keeping up with demand” for the 3M-made platform ― talked with me during this year’s annual Association for Molecular Pathology meeting, held here this week.
As GenomeWeb Daily News reported last month, 3M threw its hat into the clinical molecular diagnostics ring by teaming with Focus to develop the tiny instrument with a new line of infectious disease tests specially made for it sold under the Simplexa brand. Pictures of the instrument are hard to come by, so to get a sense of what one looks like picture a Robocop helmet, sans visor or lower jaw.
So far just one Simplexa assay ― Quest’s EUA-approved high-complexity H1N1 test ― is being sold.
As I reported last month, Quest and 3M plan eventually to launch moderate-complexity tests that will eliminate the need to independently extract and purify nucleic acid ― a proposition that several clinical lab directors I spoke with called “exciting.” (Here’s some recent listerv chatter about the system.)
According to the Quest and Focus officials I spoke with at the AMP show, Focus is working to place an Integrated Cycler at an undisclosed facility in Grass, Austria; it has “recently” placed one unit in a facility in Valencia, Spain; and has delivered at least one instrument to an undisclosed lab in the Czech Republic.
In addition, it has a “couple” of instruments going to undisclosed labs in the Middle East and has placed more than 15 elsewhere in the United States. A Quest spokesperson declined to elaborate.
Simplexa tests are performed on a CD-sized disk that is the Integrated Cycler’s version of a multiwell plate. The only test that can currently run on the instrument ― the H1N1 assay ― does not integrate the nucleic acid extraction and purification steps. The official said Focus expects to debut a disk for moderate-complexity tests sometime in the next 18 to 24 months.
It is this disk that will perform the nucleic acid extraction and purification. The Integrated Cycler is loaded with software designed by Focus and 3M to distinguish and read both kinds of disks, which are single-use only.
Quest said the Integrated Cycler will focus initially on respiratory viruses. Asked what the next indication will likely be, the official declined to name one but said it “is a safe bet” that it will be one of the more than 90 molecular respiratory tests that Focus runs in its lab. These tests would be converted to the Simplexa format. He added that Focus is looking at between 20 and 25 of these assays “closely.”