Gen-Probe said this week that Health Canada has granted the company a medical device license for Panther, Gen-Probe's fully automated and integrated molecular testing platform.
Under the new license, Panther may be used in Canada to run the Aptima Combo 2 assay, Gen-Probe's dual test for chlamydia and gonorrhea.
"Receiving a Canadian regulatory license for the Panther system is another important milestone in our efforts to create differentiated value for our laboratory customers around the world," Carl Hull, Gen-Probe's President and CEO, said in a statement. "We believe the Panther system will revolutionize molecular diagnostics by offering customers high levels of productivity and instrument flexibility that were once reserved for high-throughput clinical chemistry and immunoassay systems."
In December, Gen-Probe received CE Marking for Panther and launched the platform in Europe (PCR Insider, 12/2/10). The company said at the time that it was hoping for regulatory approval in the US by the end of this year, and in May said that it had filed Panther for 510(k) approval (PCR Insider, 5/25/11).
Panther uses the same core technologies as Gen-Probe's Tigris system, a higher-throughput molecular testing platform that has been commercially available in the US and Europe for several years.
These technologies include a proprietary target capture technique based on capture oligomers and magnetic microparticles; and transcription-mediated amplification, an isothermal amplification method that the company says can produce billions of RNA amplicons from a single target molecule in less than one hour.
However, while Tigris is targeted at high-volume clinical laboratories, Panther is intended for use in low- to mid-volume labs.
Panther features fully integrated "sample-in, result-out" automation, allowing a single operator to process 275 samples in eight hours, yielding a total of 550 test results with the Aptima Combo 2 assay. Hands-on time is less than 30 minutes, and larger customers can run Panther unattended, processing 500 samples (1,000 total Aptima Combo 2 results) in 12 hours, the company said.
Besides the Aptima Combo 2, Gen-Probe is developing several other qualitative and quantitative assays for Panther, although it did not provide additional details. In December, company officials said that Gen-Probe is also considering a qualitative Trichomonas assay, as well as putting the company's quantitative PCA3 prostate cancer test onto Panther.