Saliva Ovulation Tests Fertile Market: Saliva-based tests multiply amid demand

For decades, scientists have known that if a woman's saliva forms a telltale "ferning" pattern a bit like frost crystals under the microscope, it is the time of month when she is most likely to get pregnant.

But it's only now that saliva-based fertility testers are springing up all over the US market. Handheld microscopes in a variety of forms, including some the size and shape of a lipstick, are offered to would-be mothers as an alternative to costly urine tests or outdated traditional methods like temperature-charting.

"Sometimes something just takes hold and then everybody wants to do it," said Don St. Pierre, deputy director of the Food and Drug Administration's Office of In Vitro Diagnostics, which regulates the testers.

One tester, OvulationScope, is just coming on to the shelves at Kmart, and is scheduled to appear in Target and Wal-Mart in the coming months. The company behind it, Quest Products Inc., has ordered 70,000 of the little lipstick-sized microscopes and suggests a price of about $27, said Mark Milliman, Quest Products' cofounder.

Other testers are available online or in drugstores; they cost between $35 and $120 with names like The Donna, MaybeMOM, Ovulite and the TCI-31 Ovulation Tester.

The FDA cleared the TCI Ovulation Tester last year and the MaybeMOM Mini Ovulation Microscope in January. Other testers have received waivers freeing them of the need for specific clearance because they are similar and pose no conceivable danger.

But those waivers are raising strong protest from MaybeMOM Inc. Its senior vice president, Richard Hyken, said the FDA told the New Jersey-based company, which began marketing its microscope in America in 1999, that it was required to show proof of accuracy, and so MaybeMOM invested $90,000 in tests that ended up showing accuracy readings of 98 percent.

Meanwhile, the company slowed its marketing efforts, only to see the FDA change its opinion and start granting test waivers, causing competitors to jump into the market without any such quality assurance, he said.

MaybeMOM's attorney is pressing the FDA to require that other ovulation testers get the same 510(k) clearance that MaybeMOM received in January. The company is also considering a suit against the FDA, Hyken said.

"All kinds of things are coming in now with absolutely no regulation involved," he said. "And not only is it frustrating for us, but we look at it as not good for the public," because shoddy testers could produce poor results.

Saliva testers rely on the fact that as a woman approaches ovulation, her changing hormone levels affect the salts in her saliva, which create a telltale ferning pattern when viewed under the scopes.

The companies are seeking to tap into the growing US market in fertility products. The market for ovulation testers is about $41 million and has been growing at 6 or 7 percent a year, estimated Teresa Prego, associate director of marketing for women's health for Inverness Medical Innovations. Inverness, based in Waltham, makes the ClearPlan Easy Fertility Monitor, a computerized monitor that uses urine test sticks.

The saliva testers aim to appeal in particular to women who want a lower-cost and convenient method to improve their chances of getting pregnant than the alternatives.

Those other options include monthly urine-testing strips at $15-$30 per monthly cycle and high-tech fertilization monitors like the ClearPlan that can run nearly $200 or more.

An article in last December's "Obstetrics and Gynecology" suggested one of the best ways to detect a woman's fertile window is all but free: teaching women how to identify monthly changes in the consistency of their vaginal mucus.

But the mini-microscopes require a procedure no more daunting than dropping a bit of spit onto a lens.

Competitors argue that it is difficult for many women to interpret what they see on the microscope's screen.

Makers of the high-tech fertility monitors also point out that their monitors give women more warning about when they are going to ovulate. The saliva-testers often show the start of ferning about three or four days before ovulation, while the monitors can give users a jump of five or six days. Research has shown that women are most likely to get pregnant if they have sex in the days preceding actual ovulation.

There is a place for such saliva testers "for people who are on a strict budget, but you definitely have to be more motivated" because more labor is involved, said Philip Regas, president of Zetek, a Colorado-based company that makes the high-tech OvaCue fertility monitor. Its latest model sells for $385.

If OvaCue, which can use electrochemical measurements of both the saliva and the vaginal mucus and keeps computerized track of everything, is the Cadillac of fertility monitors, he was asked, what is the new saliva-based type of microscope?

"It's a Yugo," Regas said.

Milliman of Quest Products said that he did not think the OvulationScope would "cannibalize the market," but rather that "it's just another alternative to urine; we think women will use both."

The saliva testers' big economic advantage over urine test sticks is that they are fully reusable, while urine test sticks are single use.

The tester "is a basic thing similar to a thermometer," Milliman said.

As for actual thermometers, the thinking among medical researchers is that the old method of measuring a woman's body temperature to determine when she ovulates is just that -- old. The temperature change shows up only after ovulation occurs, and according to recent research, that is too late for optimal timing of sex.

Saliva-testing microscopes have been sold in Europe for years, and are used there for contraception as well. The FDA, however, does not allow the testers to advertise themselves as contraceptives in the United States.

In alternative medicine circles, women have been using the saliva method for years, Milliman said. "We're just kind of taking it more to the mainstream at this point."

Carey Goldberg can be reached at goldberg@globe.com