Medical Device Daily

This past month Cytyc (Marlborough, Massachusetts) celebrated the 10-year anniversary of winning FDA approval of its highly successful ThinPrep Pap Test. But the company's chief executive says neither he nor the company is resting on any laurels.

Since its approval in 1996, Cytyc has continued to add components to the system, in addition to seeking supplemental approvals for other uses for the ThinPrep diagnostic.

“The crystal ball is making this technology widely available, not only in the U.S., but worldwide,” Pat Sullivan, president, CEO and chairman of Cytyc, told Medical Device Daily “And we are focused on becoming a billion-dollar women's healthcare company by 2008.”

To date, close to 250 million ThinPrep tests have been completed, the company reports, with Sullivan noting that about 9 million tests are now completed every quarter.

Currently, Cytyc can claim 87% penetration with ob/gyns using ThinPrep, a system which includes a collection device and vial containing a liquid to capture all of the sample and a slide imaging system.

It is the only liquid-based Pap test system which also includes detection of the human papilloma virus (HPV), which is considered to be the necessary precursor to cervical cancer in women.

In November, the FDA approved a premarket approval supplement for the ThinPrep Pap Test related to the detection of endocervical and endometrial glandular lesions (Medical Device Daily, Sept. 16, 2005).

“I think what is interesting, and when we go back and think about it, there are two types of errors associated with the [traditional] Pap smear,” Sullivan said. “The first is a preparation error – and that is you take cells from a woman's cervix and you smear them on the microscope slide. Eighty percent of the sample is thrown away in the trash can. So, with the ThinPrep, you put all of the sample into a vial. You send that to a laboratory, and you get a much more homogeneous sample than you do with a conventional Pap smear technique.”

Sullivan said the company continues to seek additional approvals for the system, which can also test for Chlamydia and gonorrhea, in order to differentiate it from the competition. That competition includes TriPath Imaging 's (Burlington, North Carolina) SurePath liquid Pap product.

“The product claims and the performance claims are how we differentiate ourselves from the competition,” he said.

Sullivan pointed out that – just as a coincidence – the number of deaths from cervical cancer, which strikes about 450,000 women annually on a worldwide basis – has decreased more than 28% in the U.S. from the 16,000 deaths that were occurring in 1996 when ThinPrep was approved, and he acknowledges that the statistic is just that – something coincidental.

Sullivan's description of the company's ride to success meant negotiating a rocky road.

The ThinPrep technology was developed by David Zahniser, PhD, who completed his PhD thesis on thin-layer Pap tests in the 1970s in the Netherlands. Zahniser and another co-founder then launched the company in 1987, and Sullivan joined the company in 1991.

“I think in '91 I thought I was only going to be here five years, and I've been here 15,” Sullivan said.

Cytyc executives originally thought that ThinPrep test was going to be approved for gynecological uses in 1991, but the company “ultimately had to do some clinical trials that we didn't anticipate at that point in time.

“So, it took a lot longer – in fact, at one point in '94, we had submitted data to the FDA, and we had to start our trials all over again,” he said. “So, basically, we almost went out of business in '94.”

The company had received an FDA panel recommendation in July 1993, but Sullivan said that when the FDA was examining the application over the next six months, it “audited a couple of our sites and figured out we really didn't have the audit trail we needed to have . . . ”

The ThinPrep Imaging System was additive to the ThinPrep Pap Test, allowing those slides which are now prepared using Cytyc's tools to put cells from the cervix on the slide. Then, those slides would be scanned by the then-new imaging system. The scanning system reads the slide to determine what, if any, cells need the additional review of the human eye. Battelle (Columbus, Ohio) assisted Cytyc in the design and engineering of the system.

The ThinPrep Imaging System component was approved in 2003 (MDD, June 11, 2003), and, at the time, Sullivan described the imaging system as “another leg of growth for the company” and a “dream realized.”

Sullivan became president in March 1994 and, at the time, the company thought it was in the midst of raising its final series of private funding.

But when the company had to go back to square one with its trials, the venture capitalists that had put $40 million into the company came through with two $3 million bridge loans.

“That allowed us to keep the doors open and continue funding [the trials],” Sullivan said.

“In fact, one of the interesting things [was that] the venture capital guys were going to sell us to another publicly traded diagnostic company for a dollar,” Sullivan added, noting that the company would have taken over expenses, and the VC's would have recouped their investment through royalty arrangements.

All for naught, because the other company decided it was too risky.

Cytyc ultimately completed its initial public offering on March 8, 1996, and it won approval of the ThinPrep test on May 20, 1996.

“I think I always thought that this is either going to be a bunt single, or it's going to be a home run, and there wasn't going to be a middle ground of replacing the conventional Pap smear, which was the standard of care and is still a very effective test,” Sullivan said.

“We always knew it would have the potential to be a home run, and I think it turned out to be a home run.”

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