Dr. Michael Dan: With this new kit, a woman can not only treat herself, but can do it appropriately, by being able to diagnose herself by simple means.Nearly 75% of women in the developed world will suffer from a yeast infection at least once in their lifetime. Now, Israeli biotechnology company Savyon Diagnostics has developed the world’s first over-the-counter test for this global ailment.

Called Savvycheck, the test, which is already being sold in Switzerland, Scandinavia, and Israel, allows a woman who believes she may be suffering from a yeast infection to test and diagnose herself using a simple device that yields results within minutes.

Early feedback indicates that the new test is a welcome addition to the world of women’s health. “The response was very positive,” says Dr. Michael Dan, Professor of Internal Medicine at Tel Aviv University who was involved in the clinical trials for the test. “With this new kit, a woman can not only treat herself, but can do it appropriately, by being able to diagnose herself by simple means. This kit is an important step forward.”

Simplicity is one of the Savvycheck’s main advantages. The kit is composed of a sampling swab and disposable detection device. After a woman takes a sample from herself, she inserts the swab into the device. From there, the kit uses what’s known as lateral-flow technology – the same process used in many pregnancy tests. As the antigens contained in the vaginal sample travel down the test strip, they react with a complex containing anti-Candida antibodies, and move towards a control line and a test line. If the control line turns blue, the test is working. If the test line turns blue, the woman has a yeast infection.

Tests have shown a 100% concordance between women performing the tests on themselves and doctors performing the tests. The accuracy rate is over 90%.

“The most important element in Savvycheck is empowerment,” says Dr. Scott Lawrence, Savyon’s marketing director. “Women want to know if what they have is serious, and if they should see a doctor. This test reassures them that they know what they have and can make a decision on how to treat it based on real information.”

This information is elusive because the symptoms of yeast infection are the same as those of other common ailments such as bacterial vaginosis, trichomonas and some sexually transmitted diseases. It is therefore not surprising that women with these symptoms often treat themselves with the over-the-counter medications available to treat yeast. But for many, the symptoms will not go away.

“More than 50% of women who self-diagnose are wrong,” explains Savyon’s Scientific Affairs Manager Michal Illouz. “They take medication when they don’t have to, so the candida [yeast infection] will continue and the treatments will be less effective.”

Savvycheck is aimed specifically at diagnosing a specific form of vaginitis caused by an overgrowth of the yeast fungus candida albicans, or yeast infection. This is the most common type of vaginitis in Europe and Israel, and the second most common type in the US. It is caused by a change in pH in a woman’s vagina that can be the result of several factors – antibiotics, diabetes, pregnancy, some birth control methods, a weakened immune system or hormonal changes.

The symptoms, while usually not physically dangerous, can be painful and irritating. And, according to Tel Aviv University’s Dan, untreated yeast infection can have serious effects on a woman’s life.

“The problem of treating and diagnosing yeast infection is very stressful for women,” Dan told ISRAEL21c. “The infection can cause psychological and conjugal problems. Since yeast infections can make sexual intercourse extremely painful, marital problems can result.”

Prior to the invention of Savvycheck, yeast infection was most often diagnosed by doctors using an examination. “For some reason, doctors based their diagnosis on visual impressions, which is a very misleading notion,” explained Dan. “It was a real problem for many women because they were not properly diagnosed.”

Other diagnostic methods were taking a culture, and waiting six or seven days to receive a result, or microscopic examination, which was rarely used. Both of these methods required expertise and time, and increased health care costs. Now, with Savvycheck, also being sold to doctor’s offices, a doctor can get an accurate diagnosis within ten minutes, while the patient is still in the office.

Savvycheck was the brainchild of Dr. Martin Lee, Savyon Diagnostic’s controlling partner and CEO. Lee, who has a PhD in Biochemistry and Microbiology, owned and directed a major laboratory in North Carolina before moving to Israel in 1999. He immediately began looking for a company that would be able to make the products he had in mind.

In January 2003, Lee bought control of Savyon Diagnostics, which was already known for its test for the sexually-transmitted disease Chlamydia and was also making tests for HIV and urinary tract infection (UTI). “With its experience in diagnostic testing, I saw reasons why a yeast infection test would be a good product for Savyon,” Lee told ISRAEL21c.

The product, retailing at about $9.95, hit the shelves in Israel in late September, and customers have been very receptive. “The product has been in drugstores for the past month and sales have already exceeded expectations,” according to Savyon’s Lawrence.

The company has started the process of gaining Food and Drug Administration (FDA) approval in the US and expects the test to be on shelves in the US in about a year. Savyon has high hopes for sales of the product.

“This product and the family of products that will come from it will make Savyon a much bigger company,” predicts CEO Lee.

For now, the 55 employee company with headquarters in Ashdod, south of Tel Aviv, will continue to make high quality diagnostic kits for international distribution.

“Savyon is one of a very small number of companies that produces things in Israel, physical things for which we get paid and employ Israelis. And we’ve been doing that for 22 years,” says Lee. “My vision is that we’ll keep doing that for a long time to come.”