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Cancer Resources > Cancer News > Cancer News from Reuters > Reuters Cancer News > 2000 > June

FDA approves Cytyc's ThinPrep 3000 Processor

WASHINGTON, June 01 (Reuters Health) - The US Food and Drug Administration (FDA) has given premarket approval to Boxborough, Massachusetts-based Cytyc Corporation for the ThinPrep 3000 Processor used for unattended batch processing of samples generated by the firm's ThinPrep Pap Test for cervical cancer screening.

The ThinPrep 3000 Processor, designed specifically for use in large volume laboratories, is the first fully automated sample preparation system with "true walk-away processing capabilities," said Patrick Sullivan, Cytyc president and CEO.

The firm's newer processor can process 80 samples in 2.5 hours, compared with the earlier model's capability of 25 samples per hour, processing one sample at a time, Joseph Kelly, Cytyc senior vice president and CFO told Reuters Health.

While the 3000 processor is "slightly faster," the latest system's true advantage is its ability to operate unattended," Kelly noted. "It replaces the technician."

Laboratories already using the 2000 system "will probably keep [the 2000 model] and use it for non-gynecological samples and as a back-up system," Kelly said.

The company has manufactured more than 1,500 ThinPrep 2000 Processors for sale in the US and worldwide. Sales of its processors reflect a relatively small portion of Cytyc's business, Kelly said, noting that sales of the ThinPrep Pap Test is the factor driving the company's revenues.

Cytyc has produced 15 million ThinPrep Pap Tests, for which laboratories that process nearly 80% of all US Pap tests are trained to provide. The firm's Pap test held about 25% of a $50 million US market by end of first quarter 2000, up from 11% for the same time period in 1999.

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