Seegene (Rockville, Maryland) is hoping to encourage more widespread screening of sexually transmitted diseases (STDs) and Human Papillomaviruses (HPVs) with its new test designed to detect the most prevalent STDs and HPVs using a single sample.

According to the company, more than half of all people will be infected with a STD at some point in their lifetime, yet less than a third of these individuals are routinely screened for STDs.

Seegene’s new Seeplex STD/HPV test is designed to screen for Chlamydia Trachomatis (CT), Neisseria Gonorrhea (NG), 14 high-risk types of HPV and five low-risk types of HPV in a single tube, at the cost of a single pathogen test.

Jessica Joung, U.S. marketing manager for Seegene, told Medical Device Daily that cost-effectiveness is one of the primary advantages of the company’s new test. She said an HPV test alone can cost about $50, while Seegene’s STD/HPV test costs about $20 for a single assay offering multiple screenings.

The company noted that current clinical STD and HPV screening procedures are not cost efficient, since requiring a separate test to detect each indication for CT, NG, HPV High Risk, and HPV Low Risk.

Because STD infections have a high co-infection rate (with individuals often exhibiting more than one STD infection), and HPV is the main cause of cervical cancer, the company says that healthcare systems are sorely in need of a more effective and economical diagnostic capable of detecting the most prevalent STD and HPV pathogens.

The Seeplex STD/HPV test works similarly to another test the company introduced in September, called the Seeplex 18-plex Respiratory Test. That test is designed to detect 18 different pathogens, including 11 different respiratory RNA viruses, two DNA viruses and five pneumonia bacteria from samples, including nasopharygeal aspirates, nasopharygeal swabs and bronchoalveolar lavage (Medical Device Daily, Sept. 12, 2007).

Seegene says its Seeplex technology works in combination with automatic detection systems such as capillary electrophoresis and delivers “a benchmark in testing accuracy, efficiency and cost-effectiveness.”

“This test is more focused on the woman’s health [because] women routinely take an HPV test, so when they are doing the HPV test, in addition they provide the [CT/NG] information,” Joung said.

By being able to quickly and more accurately diagnose STD/HPV infections in patients, doctors will be able to write better prescriptions and provide the best course of treatment, Seegene said.

“Since most STD and HPV cause no noticeable symptoms, they go undetected. These asymptomatic infections can be diagnosed only through testing. Therefore, the only way to slow the spread of STD/HPV along with their dangerous effects, like cervical cancer, is to provide routine and ubiquitous screening programs,” said Jong-Yoon Chun, CEO and founder of Seegene.

According to a study in the Feb. 28, 2007, issue of the Journal of the American Medical Associaiton, about one in four females in the U.S. between the ages of 14 and 59 years is at risk for sexually transmitted infections, which typically exhibit no visible symptoms. High-risk HPV types are detected in 99% of cervical cancers and HPV type 16 and type 18 cause more than 70% of cervical cancers.

Alarmingly, individuals diagnosed positive for HPV are on average infected with up to five different types of HPVs, the company says.

“This is the first diagnostic test to cover most prevalent STDs, so we are very proud of it,” Joung said.

Seegene also said that the high STD infection rates among the general population place an “enormous” financial burden upon healthcare systems and on patient point-of-care systems. The company cites information from the Center for Disease Control and Prevention which estimates that the 9.1 million new STD infections among 15-to-24-year-olds in the U.S. in 2000 cost $6.5 billion in direct medical expenses.

Seegene, currently in its fourth year of having a U.S. presence — its primary headquarters are in Seoul, South Korea — moved into the molecular diagnostics sector last year.