The Company’s first product will be the Rapid Periodontal Test™ (RPT™): an inexpensive, chair-side saliva test for routine dental examination to:

• screen patients for periodontal disease
• aid in diagnosis by confirming the presensce of active periodontal disease
• aid in patient compliance.

In addition to causing painful gum disease and bone loss, active periodontal disease is a known risk factor for heart diseases like endocarditis, valve disease or heart failure, and for low birth weights/premature births. As bacteria normally colonize the mouth, dentists need to know when the active disease begins, and to ascertain risk factors for heart disease and pregnant patients.  Since GeneEx's test detects only virulence markers produced during active infections, the RPT is the only test capable of diagnosing active periodontal disease today.  The RPT requires only a drop of saliva, and runs like any easy-to-use, home-based test kits such as pregnancy tests

The RPT Market beyond dental: OB-GYN and Cardiovascular

Periodontal disease is a known risk factor in low birth weights/premature births, causing up to 18% of low birth weights/premature births. Periodontal disease is also a known factor for heart disease, including endocarditis, valve disease and congestive heart failure, especially in patients with existing heart conditions, including murmur. It is also a contributing factor in other diseases such as diabetes, pancreatic cancer and Alzheimer’s. Dentists, Cardiologists and OB-GYNs will welcome RPT as a way to detect this significant risk factor, both for early treatment and to prevent serious complications.

Additional Market Opportunity:  Group A Streptococcus and fungal infections

GeneEx plans to launch a saliva based, rapid antigen detection test for group A streptococcus (GAS) to both professional and consumer (over the counter) markets.  Like the RPT, this test will detect only the virulence markers produced by active GAS pathogenesis, not just the presence of GAS, and reduce unnecessary prescription of antibiotics. Strep A infections are also a known risk factor for heart disease and rheumatic fever.

Approximately 500 million cases of pharyngitis (sore throat) occur annually in the U.S. resulting in 15 million physician office visits.  Group A streptococcus (GAS) is a common cause of pharyngitis (“strep throat”) and is most common in school-age children, accounting for 15-36% of pediatric pharyngitis.

The standard diagnostic procedure for strep throat in medical offices is a throat swab with a rapid antigen detection test.  This tests measures only presence of GAS, not active infection, and results in unnecessary prescription of antibiotics. A saliva-based rapid antigen detection test for active GAS for over the counter use does not currently exist.  Beyond GAS, GeneEx is targeting fungal infectious like aspergillosis, candidiasis and cryptococcosis. Currently, effective tests for these infections do not exist.