Synbiotics Files to Start Selling Test for Chlamydia

Synbiotics, which previously concentrated on diagnostic tests used in veterinary medicine, has filed a notification with the Food and Drug Administrattion to begin selling a rapid test that will determine the presence of a sexually transmitted disease that affects humans.

The new test, which will cut from six days to 30 minutes the time needed to determine the presence of chlamydia, is “our first true entry into clinical reagents for the human-use market place,” according to Greg Soulds, Synbiotics’ marketing director.

Last year, there were 4.6 million new cases of chlamydia reported in the United States, according to Soulds, who said the market for the new testing kit is estimated at about $30 million. Synbiotics hopes to eventually capture 5% of that market, Soulds said. He said chlamydia is a debilitating, sexually transmitted infectious disease.

In addition to the chlamydia test, Synbiotics is “close” to registering with the FDA a pair of tests that will determine the presence of two other infectious diseases, Soulds said. However, those two tests will be aimed “not at sexually transmitted infectious diseases but at diseases that are more closely related to pediatrics.”

Synbiotics has begun “discussions” with several distribution companies that are “well-positioned in the doctor’s office and central diagnostics laboratories,” Soulds said. Synbiotics, which faces competition from at least one other company in the rapid chlamydia test market, eventually hopes to generate half of its revenues from human-use products.