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UTAH FIRM SELLING PAP TEST DEVICE

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A Utah company is marketing an invention that its officers believe can save the lives of many women - an improved device to obtain cells for Pap smear tests.

The patented device is called the "Exact-Touch Saccomanno Pap Smear Collection System." The company is BAAL Medical Products, incorporated in 1990 and based in Midvale.The "Saccomanno" in the product's name is for its inventor, Dr. Geno Saccomanno, who was educated at the University of Utah and is a resident of Grand Junction, Colo., said BAAL company Vice President Donald L. Garrison.

"Dr. Saccomanno asked us to help him develop this product," Garrison added. "He had an idea, and we put the idea on paper, made some prototypes, made some clinical trials."

Larry Page, the company's president, added that Saccomanno also helped educate BAAL about how the device should be used and how it should be developed.

All rights to the "Exact-Touch" device are held by BAAL; the device itself is manufactured and distributed for BAAL by the company Shandon Lipshaw, which is located in Pittsburgh, Pa.

Pap smears are the main method of detecting the presence of cervical cancer, which is highly treatable if discovered early. Cervical cancer is one of the most common types of cancer to affect women's reproductive organs, according to the "Mayo Clinic Family Health Book."

The reference adds that invasive cancer of the cervix kills just 3 percent of American women who die of cancer. Still, Garrison said, cervical cancer is responsible for the deaths of about 4,500 American women per year.

"If you're one of those 4,500, it's a lousy deal," he said.

When a doctor takes a Pap smear, a device is used to scrape off some of the cells of the cervix, both at the opening and inside. Endocervical cells - those inside - are more difficult to retrieve.

Because of its design, with tiny bristles to remove cells inside and branches with bristles to simultaneously remove cells from the opening, company officials say, the plastic Exact-Touch device is an improvement over other collection devices.

The system passed scrutiny by the U.S. Food and Drug Administration. According to BAAL, it has a proven retrieval rate of 95 percent to 98 percent in the crucial endocervical cells.

"Endocervical cells are more difficult to collect than ectocervical (at the surface of the opening) cells, and both are key in diagnosing cervical cancer," said Diana Jackson, spokeswoman for the Summit Group, an advertising organization representing BAAL.

"Our endocervical cell retrieval rate is between 95 and 98 percent - ectocervical cell, at 100 percent," said Garrison.

He said other some devices used may require two separate procedures for the two types of cells. When a cell sample is taken it is placed on a microscope slide, then covered with a preservative.

Lab technicians evaluate the cells for abnormalities that can signal cancer or a precancerous condition.

"The cells that are deposited during the first procedure start to dry while you're waiting for the second one to be collected and deposited," he said.

"When a cell dries, it's no longer interpretable, or at least very difficult for interpretation."

With the "Exact Touch," only one procedure is needed while taking the Pap smear.

"I think it's important for women to know what (devices) their doctors are using and what the accuracy rates are," Jackson said. If their doctors are using something with a lower accuracy rate, then they should know about the new device.

"Recently, the lab error (in interpreting Pap smears) was estimated at 20 to 40 percent," Garrison said.

He cited a host of possible causes, including human error, poor quality of smear slides, or air drying of the cells.