FDA Clears Gen-Probe Incorporated's PANTHER® System for Use With APTIMA Combo 2® Assay

Published: May 08, 2012

SAN DIEGO, May 8, 2012 /PRNewswire/ -- Gen-Probe Incorporated (NASDAQ: GPRO) announced today that the US Food and Drug Administration (FDA) has cleared its PANTHER system, a fully automated and integrated molecular testing platform designed with the flexibility to handle a wide range of testing needs. The PANTHER system can initially be used to test for the common sexually transmitted infections Chlamydia trachomatis and Neisseria gonorrhoeae with the APTIMA Combo 2 assay.

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"FDA clearance of our PANTHER system represents a significant milestone for Gen-Probe," said Carl Hull, Gen-Probe's chairman and chief executive officer. "It is a credit to the scores of talented and dedicated scientists and engineers who made it happen. 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-result capabilities to low- and medium-volume labs. This clearance will now allow the Company to significantly increase its addressable market domestically, following on the successful international launch of PANTHER in late 2010. The unique capabilities of future versions of the PANTHER system will provide Gen-Probe with the opportunity to enter new and attractive markets in the future such as viral load testing."

Key features of the PANTHER system include:

  • Fully integrated "sample-in, results-out" automation. A single operator can process 275 samples in eight hours on the PANTHER system. Hands-on time is less than an hour, yielding seven hours of walk-away freedom per shift. For larger customers, the PANTHER system can continue running unattended, processing up to 500 samples in 12 hours.
  • Primary tube sampling with random access loading for maximum flexibility and productivity. Multiple assays can be run from a single sample, and operators have continuous access to samples, reagents and consumables.
  • A customer-driven design, intuitive software for ease of use, and remote diagnostics capabilities.
  • Extensive process controls including positive sample identification, liquid level detection, reagent dispense verification, and radio frequency identification (RFID) tags on fluid containers providing customers confidence in results.
  • A small footprint and compact profile with a width of 48 inches, a depth of 32 inches, and a height of 69 inches.

Gen-Probe will begin shipments of PANTHER systems to US customers during the second quarter of 2012. Additional APTIMA women's health assays such as APTIMA® Trichomonas vaginalis and APTIMA® HPV are expected to be added to the PANTHER menu as they progress through the regulatory process, and several other qualitative and quantitative assays are currently in development.

The PANTHER system builds on the success of Gen-Probe's TIGRIS system, which was the first fully automated, high-throughput molecular testing system for large laboratories. Since its launch in 2004, more than 650 TIGRIS systems have been installed at clinical diagnostic and blood screening laboratories around the world.

About Gen-Probe

Gen-Probe is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility. Gen-Probe is headquartered in San Diego and employs approximately 1,400 people. For more information, go to http://www.gen-probe.com.

Caution Regarding Forward-Looking Statements

Any statements in this news release about our expectations, beliefs, plans, objectives, assumptions or future events or performance are forward-looking statements. These statements are often made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning possible or expected results of operations, regulatory approvals, the development and commercialization of new products, future sales and product menu offerings, growth opportunities, and plans of management are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expressed or implied. Some of these risks include: (i) the risk that other assays will not be approved for use on the PANTHER system; (ii) the possibility that the market for the sale of our PANTHER system or other new products may not develop as expected; (iii) the risk that our intellectual property surrounding the PANTHER system will be invalidated; and (iv) the risk that we may not be able to compete effectively. This list includes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC. We assume no obligation and expressly disclaim any duty to update forward-looking statements to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.

Al Kildani
Sr. director, investor relations and
corporate communications

SOURCE Gen-Probe Incorporated

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