Lipstick Saliva Ovulation Testers: Is the Public Being Misled?
Hauppauge , NY April 25, 2004 – In December of 2001, the FDA approved the nation’s first saliva ovulation test kit. This breakthrough technology called the OvuLook Ovulation Tester offered women the first at home alternative to inconvenient urine tests. The new test showed women a unique pattern that occurs in saliva up to 72 hours prior to ovulation.
OvuLook ’s manufacturer was required to conduct two separate FDA studies to prove the effectiveness of their device. In the first study, the company used hand drawings of what fertile saliva looked like. The study yielded a 59% accuracy rate.
In OvuLook ’s second clinical trial the company provided instructions with actual microscopic photographs of saliva patterns, not the hand drawings. The new photos allowed study participants to correctly identify the ovulation patterns, called ferning, with an accuracy rate of almost 100%.
About a year ago, the FDA blanket cleared all saliva testers based on the Ovulook studies. Because of OvuLook ’s patents, companies eager to capture a share of this emerging market designed a new type of saliva tester. These new non-patentable devices are commonly referred to as lipstick testers.
Similarly, because of OvuLook ’s copyrights, all but one of the new lipstick testers include instruction sheets with hand drawings comparable to OvuLook ’s original drawings. Herein lies the problem. These lipstick testers claim a 98% accuracy rate, but according to previous FDA studies, hand drawings yielded a 59% accuracy rate.
“The fact that the FDA isn’t paying closer attention to instructions in saliva ovulation test kits could leave women who use these lipstick tests worried that they are not ovulating,” said Kathleen Fry, MD, the former president of the American Holistic Medical Association. “Knowledge is crucial when using these kits and women rely on the FDA to monitor claims.”
“The instructions in the lipstick test kits do not give women the best chance to identify peak fertility”, said Tom Mitchell , founder of OvuLook , LLC. “The OvuLook ’s instruction booklet shows women exactly what the saliva samples look like. In addition, the OvuLook ’s thirty-one day tracking disk allows women to take saliva samples daily and create an ongoing ovulation calendar.”
Women today face many obstacles in their quest for a child. It is proven that as women age it becomes increasingly harder to conceive. Statistics show a 400% increase of first births to women 30 years and older. Furthermore, US census data indicates that the number of women who wanted children and are still childless after age 40 has doubled in 20 years. Other hurdles to conception include employment demands, stress, busy schedules, environmental factors and male fertility issues.
All of these facts may challenge the approximately 16 million women in the US who are actively trying to conceive. This motivated market is expected to generate over $100 million in sales of ovulation test kits this year. As these women trust the FDA to monitor fertility devices, it is important that they are not misled with erroneous information and false promises.
For information on ovulation test kits and fertility, visit www.ovulook.com or call 1-800 Ovulation.