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FDA Clears Gen-Probe's Panther MDx Platform

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared Gen-Probe's Panther, a fully automated and integrated molecular testing platform, the San Diego-based company announced today.

Gen-Probe will begin shipping the system to US customers in the current quarter. Initially, Panther can be used to test for chlamydia trachomatis and Neisseria gonorrhoeae with the Aptima Combo 2 assay. Additional Aptima women's health assays, including the Aptima Trichomonas vaginalis and Aptima HPV, are anticipated to be added to the Panther menu following regulatory approval. Other qualitative and quantitative assays are under development, said Gen-Probe, which is in the process of being acquired by Hologic.

Last June, CFO Herm Rosenman said at an investor conference that the company plans to develop assays for Panther for the hepatitis C virus and HIV, and that the company also plans to reformulate its PCA3 prostate cancer test for the platform.

Gen-Probe filed its 510(k) submission for the system with the FDA a year ago.

"Just as Tigris revolutionized molecular diagnostic screening with an unparalleled level of throughput and automation, we believe Panther will continue that revolution by bringing the power of fully automated, sample-to-answer result capabilities to low- and medium-volume labs," Gen-Probe Chairman and CEO Carl Hull said in a statement.

The system allows a single operator to process 275 samples in eight hours, and hands-on time is less than an hour, yielding seven hours of walk-away freedom per shift, Gen-Probe said. For larger customers, Panther can run unattended and process up to 500 samples in 12 hours.

Panther also has received marketing approval in Canada and was launched in Europe in late 2010.

In a research note, Oppenheimer analyst David Ferreiro said Panther has had "moderate success in Europe," adding about 1 percent to Gen-Probe's revenue growth in Q4 2011. The system should help the company expand into lower volume settings and neutralize the threat of decentralization from Cepheid's GeneXpert system when its chlamydia/gonorrhea test receives expected FDA 510(k) clearance in the second quarter, he said.

In early Tuesday trading on the Nasdaq, shares of Gen-Probe slipped a fraction of 1 percent to $81.32.