NanoLogix (PINK SHEETS: NNLX), an innovator in the accelerated detection and identification of microorganisms, announced today that the University of Texas Health Science Center in Houston is enrolling 300 patients in an ongoing clinical trial to study the speed and accuracy of NanoLogix technology.
The trial is designed to compare NanoLogix technology to current methods in use for detection and identification of Group B Streptococcus (GBS) in pregnant women. Initial results obtained last spring at UTHSC-Houston show the technology identifies GBS in two to six hours. This is 8 to 24 times faster than the conventional methods of PCR (DNA sequencing) and traditional petri culturing, either of which can take 48 hours or more.
Statement from University of Texas Health Science Center in Houston:
"The University of Texas Health Science Center in Houston obstetrical service, as do most obstetrical services, has been following the CDC guidelines for the prevention of neonatal GBS infection,” said Jonathan Faro, M.D., Ph.D., Chief Resident In Obstetrics & Gynecology and the director of the clinical trial at the University of Texas Health Science Center. “Therefore, all women receiving prenatal care are screened for vaginal colonization of GBS between 35 and 37 weeks. GBS not only causes significant infection which can result in death of the newborn, but can also cause significant infection in the mother. Therefore, universal screening and the administration of antibiotics during labor have become the standard care in the United States and many other countries."
"I am currently Chief Resident in Obstetrics & Gynecology, and as the practicing obstetrician I have observed that penicillin is administered to countless number of women whose GBS status is not immediately known. Traditional GBS determination requires at least 48 hours, even if PCR is used. When using PCR the detection of GBS is not performed from a direct patient specimen but the organism (GBS) must be isolated in pure culture. Traditional detection of GBS takes time but because of this, antibiotic is being administered to women who are not colonized by GBS. The administration of antibiotic unnecessarily adds to the potential of the bacteria developing antibiotic resistance."
"Thus, the current methodology presents two problems; (1) delay in determining if the patient is colonized with GBS and (2) administration of antibiotic unnecessarily. The Nanologix method of detecting GBS offers a definite advantage over the current methods of detecting GBS. The Nanologix technology allows the identification of GBS in as little as two to six hours, a fraction of time compared to previous methods. This has the potential to change the way physicians approach GBS colonization in labor. Initial studies are now underway to compare the Nanologix method with the traditional culture technique. We at the University of Texas Health Science Center in Houston are excited to be a part of these early studies. A clinical trial is underway in which 300 patients will be enrolled, and the traditional method of culturing and identifying GBS will be compared with the Nanologix method. We will also begin work with Nanologix in the near future to study growth and identification of MRSA, as rapid detection of this microbe would be of great benefit."
"When it comes to bacterial cultures, physicians and patients have grown accustomed to waiting days for results. We are forced to treat empirically even in the face of active infection. The new method offered by Nanologix has the potential of cutting the wait time down drastically. It is clear that microbes aren’t waiting for us–why should we wait for them?"
End of statement
NanoLogix CEO Bret Barnhizer stated that "We at the company are excited that NanoLogix has been invited to work with the University of Texas Health Science Center on this clinical trial. Our association has progressed from initial lab testing of our technology beginning in 2009 to the present project. We anticipate much additional work over time focused on GBS and other bacteria, including MRSA (methicillin-resistant staph aureus), and would like to thank Dr. Faro and the other physicians and technicians at UTHSC-Houston who are involved in this trial".