New Real-Time Multiplex PCR with the Anyplex II STI-7 Detection Assay

Seegene has announced the commercialization of its first real-time assay based upon its new TOCE technology. The Anyplex™II STI-7 Detection Assay will provide clinicians with a powerful new tool to help protect health and prevent the spread of sexually transmitted infections (STIs), also known as sexually transmitted diseases (STDs).

The Anyplex II STI-7 Detection Assay is the only multiplex real-time PCR test that can simultaneously detect seven of the more common causes of STIs from a wide range of specimen types such as, urine, vaginal and urethral swabs, and liquid-based cytology specimen. The assay provides a new benchmark for fast, effective and economic STI screening.

More than half of all people will experience a sexually transmitted infection (STI) at some point during their lifetime. The Centers for Disease Control and Prevention (CDC) estimates that a total of almost 19 million new sexually transmitted infections occur each year, of which at least half are among 15 to 24 year-olds. In addition, the CDC estimates that STDs cost the U.S. health care system upwards of $15.9 billion annually.

Despite the high infection rate and its associated healthcare costs, less than a third of these individuals are routinely screened for STIs. The Anyplex II STI-7 Detection assay is designed to help address this challenge.

The Anyplex II STI-7 Detection assay enables clinicians to simultaneously detect the presence of; Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium, Mycoplasma hominis, Trichomonas vaginalis, Ureaplasma urealyticum,and Ureaplasma parvum.

The current standard of care for clinical STI screening involves using a separate test to detect the presence of each possible pathogen. Most commercially available tests only focus on detecting the two most prevalent bacterial causes of STIs: CT and NG. However, since most STIs do not show noticeable symptoms, it is necessary to screen for a wider range of pathogens. Further complicating STI diagnosis is that different pathogens can cause similar symptoms, but the antibiotic treatment regimen may differ depending upon the pathogen. This complexity of issues makes simultaneous and accurate STI detection key to cost-effective patient care.

"Anyplex II STI-7 Detection assay gives clinicians an advanced tool for making fast, accurate and cost-effective STI diagnoses," said Dr. Jong-Yoon Chun, Chief Executive Officer of Seegene. "Using a wide range of patient samples, physicians can now make optimal healthcare treatment decisions within hours, positively impacting the health of the patient and the economics of the healthcare system."

The Anyplex II STI-7 Detection Assay is based on Seegene's recently introduced TOCE™ technology, which turns any multiple color real-time PCR instrument into a powerful multiplexing platform. TOCE enables complex multiplexing in a single fluorescence channel, provides consistent Tm values regardless of the sequence variation of the target, and a level of sensitivity better than that of currently utilized probe-based singleplex real-time PCR assays.

Dr. Chun added, "The use of TOCE-based assays, such as Anyplex II STI-7 Detection Assay, also gives clinical laboratories a powerful method to leverage their investment in existing real-time PCR instrumentation."