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“It’s a very exciting grant. There is a great need for it, not just in the United States, where there were 1.2 million reported cases last year, but worldwide, with over 92 million sexually transmitted infections occurring annually.”
Reducing Disease Across the Globe
CHORI Scientist Wins $3.8 Million Grant to Develop New Tools for Diagnosing Chlamydia Infections

CHORI clinical scientist Deborah Dean, MD, MPH, with colleague Richard Selden, MD, PhD, of Network Biosystems has received a 5-year, 3.8 million dollar Small Business Innovative Research (SBIR) grant from the National Institutes of Health (NIH).

Dr. Dean will be partnering wtih Network Biosystems to create a new rapid method for diagnosing Chlamydia trachomatis infections that could revolutionize their identification and treatment. The grants are specifically designed to stimulate partnerships between small businesses and scientific investigators in the development of innovative technologies related to improving health.

C. trachomatis is the number one cause of preventable blindness and bacterial sexually transmitted disease (STD) in the world, causing pelvic inflammatory disease and infertility, as well as being implicated in the transmission of human immunodeficiency virus (HIV). Current methods for diagnosing a C. trachomatis infection, however, have significant drawbacks.

“To begin with, the nucleic acid amplification tests, or NAATs, are expensive, so people who don’t have symptoms but have a silent infection don’t get tested – and don’t get treated,” says Dr. Dean.

This is no small problem, with statistics showing that 70 percent of women and 50 percent of men present no symptoms of chlamydial infection. In addition, the tests have to been done in what Dr. Dean refers to as a batch run – multiple samples processed at the same time - and show a lack of concordance in test results between different NAATs for the same samples. Further, the  NAATs are not able to differentiate one C. trachomatis strain from another.
"There are different chlamydial strains with different virulence. The difference in how the strains should be treated is huge - one antibiotic dose for just one day for the less virulent strains, or 10 to 14 days for the more virulent."
While the resulting worldwide health and economic burdens are enormous, Dr. Dean alone wouldn't have the capacity to do what the situation calls for: develop a whole new testing platform that can both be mobile and diagnose a single sample in a reasonable amount of time.

By partnering with Tim Read, PhD, at Emory University and Dr. Selden for the SBIR NIH grant, however, Dr. Dean has found a way to harness her decades of chlamydial research expertise with an innovative new technology that could represent a huge breakthrough in both understanding the prevalence of symptomatic and asymptomatic chlamydial infections, as well as significantly improving their treatment.

“Adapting Richard’s technology will allow us to take a clinical swab from a woman’s cervix, pop it into a little pouch that digests the sample cells’ membranes to release DNA, and put the pouch into a machine that then detects and amplifies the DNA, sequences it, and tells you which chlamydial strain is present,” says Dr. Dean.
“Just knowing a simple yes or no within an hour in a doctor’s office will be fantastic, because the treatment approach can be devised right there, with the patient in front of you.”

In addition to providing this rapid, “point-of-care” diagnosis on the spot, the new technique will allow patients to be tested for chlamydial infection after treatment as well - a so called test-of-cure.

As Dr. Dean explains, “Having someone come back to see if the infection is actually cured is hugely significant with chlamydial infections, because we suspect that even though people are getting treated, not all infections are completely cleared, and so the treatment would need to be refined. There is no way of doing that right now. But with the method we’ll be developing, we’ll actually be able to do a test-of-cure.”

The new technique will have the capacity to provide the truest snapshot to date of the actual incidence of this silent but global epidemic, while simultaneously providing the opportunity to treat infections on a case-by-case basis and adapt the treatment if it doesn’t work.

“It’s going to provide an unprecedented opportunity to detect chlaymdial infections in real time and treat them effectively so that we can start to decrease the tremendous global burden of this insidious bacteria,” says Dr. Dean.

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Tuesday, May 17, 2011 8:19 AM

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