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Gen-Probe Launches CE-Marked MDx Platform in Europe, Targeting Lower-Volume Labs


By Ben Butkus

Gen-Probe said this week that its newest fully automated "sample-to-answer" molecular testing platform, Panther, has been CE Marked and is now available for sale in Europe a month ahead of schedule and following more than three years of development.

The new platform is expected to help Gen-Probe capture market share in the area of molecular testing at mid- and low-volume clinical laboratories, clinics, and physicians' offices as it competes with platforms from companies such as Roche, Qiagen, Cepheid, and Becton Dickinson, according to analysts.

In addition, Gen-Probe is hoping that Panther will be available in the US by the end of 2011, subject to the US Food and Drug Administration regulatory approval process, Michael Watts, Gen-Probe's vice president of investor relations and corporate communications, told PCR Insider this week.

The Panther platform uses the same "Gen-Probe suite of core technologies" as Tigris, Gen-Probe's higher-throughput molecular testing platform, which is already on the market in the US and Europe, Watts said.

These technologies include its 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.

Watts said that Tigris' throughput in an 8-hour shift is about 450 samples, plus "a couple of hours or less of hands-on time." Meantime, Panther can clear about 275 samples in the same amount of time, with less than an hour of hands-on time.

"It's clearly targeted to a lower-volume customer, although if labs are running 250 or 275 molecular tests a day, that's still a pretty high-volume lab," Watts said. "The important thing is that Panther has the flexibility to meet the needs of that lab or a smaller lab doing a fraction of that in terms of volume."

Panther also features primary tube sampling with random access loading, allowing multiple assays to be run from a single sample; software including remote diagnostic capabilities; and "extensive process controls" including positive sample identification, reagent dispense verification, and radio frequency identification tags on fluid containers, Gen-Probe said.

As would be expected, Panther's footprint, about 4 feet by 2.5 feet, with a height of just under 6 feet, is about two-thirds that of Tigris; and it also costs less, although Watts declined to disclose a list price, citing competitive concerns.

Watts did say that the pricier Tigris costs between $400,000 and $500,000, but noted that "the vast majority of our customers don't actually purchase the box. Instead, they make use of a typical reagent rental agreement under which we recover our instrument costs through sales of assays that run on the box."

He added that the company expects to follow the same model for Panther.

The upshot is that Panther should provide Gen-Probe access to a molecular testing market that it did not previously have.

In a research note published yesterday, analysts from Mizuho Securities wrote that Panther is "integral to the company's long-term growth strategy" and that it expects that "decentralization of molecular diagnostics will expand their use into small hospital labs, physician offices, and clinics — enlarging the addressable market."

Similarly, Leerink Swan analysts wrote in a research note that they view Panther "as important for gaining STD share in Europe and defending share in the US, with some menu optionality based on its ability to do quantitative testing as well as qualitative testing."

In countries that recognize the CE Mark, Panther can initially be used to perform Gen-Probe's nucleic acid tests for chlamydia and gonorrhea, including the Aptima Combo 2, Aptima CT, and Aptima GC assays.

The company said that it is developing several other qualitative and quantitative assays for the platform.

"Another one we've talked about in the very near term is our human papillomavirus assay, and that should be available very shortly," Watts said. "Longer term, on the qualitative side, we're considering a Trichomonas assay, which obviously fits with the rest of our women's health portfolio. And on the quantitative side we've talked about putting our PCA3 prostate cancer test on Panther a couple of years down the road."

The Misuho research note also underscored the importance of continued expansion of Panther's test menu, "especially in light of increasing competition from Cepheid, Qiagen, Becton Dickinson, Roche, Beckman Coulter, Nanosphere, and Autogenomics." The investment firm also wrote that it remains "cautious" on the multiplexing capability of Panther, and "expects to gain greater clarity on this aspect of the instrument as the test menu develops."

Likewise, Leerink Swan analysts wrote that Panther would be competitively positioned against the Roche Cobas 4800, Qiagen's QIAsymphony RGQ, and eventually the BD Viper LT, once it hits the market. "We believe Panther's throughput is greater than QIAsymphony RGQ and comparable to the Cobas 4800, but the instrument's menu will be more limited."

Watts said that in the coming year, besides new test development, Gen-Probe will be focused on building out the market for Panther in Europe, "but as we move into next year we'll be just as focused on getting US approval for the instrument. A lot of that of course depends on regulatory review times, which to a large extent is out of our control. But we would roughly expect Panther to be available in the US by the end of 2011."

Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com

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