NanoLogix (OTC MARKETS: NNLX), a biotechnology innovator in the rapid detection and identification of live-cell bacteria and microorganisms, announced today that the American Journal of Perinatology has published a peer-reviewed paper from the University of Texas Health Science Center - Houston confirming NanoLogix BioNanoPore (BNP) and BioNanoFilter (BNF) Quick Test technology detect and identify Group B Strep in four to six hours. The published results are in stark contrast to current Petri culturing or PCR Protocol (DNA sequencing) methods. While those conventional methods require between 48 to 72 hours of incubation to obtain results, the NanoLogix diagnostic technology for Group B Strep has proven to be 12 to 18 times faster.
The American Journal of Perinatology is an international, peer-reviewed, and indexed journal publishing 10 issues a year dealing with original research and topical reviews. It is the definitive forum for specialists in obstetrics, neonatology, perinatology, and maternal/fetal medicine, with emphasis on bridging the different fields. The journal abstract can be found at: https://www.thieme-connect.com/ejournals/abstract/ajp/doi/10.1055/s-0031-1285099. Registration is required to access the full text of the journal article.
"We continue to be amazed at both the consistency and reliability of this NanoLogix technology," said Jonathan Faro, M.D., Ph.D., Assistant Professor in General Obstetrics & Gynecology at UTHSC - Houston and lead author of the study. "It is very rewarding to see basic science research apply so fluidly to the clinic and office setting. We consider ourselves very lucky to be involved with studying the application of the NanoLogix BNP and BNF Quick Tests as they apply to Group B Streptococcus. This validation is just a very large tip of an incredibly enormous iceberg, and we are anxious to study this technology with additional organisms and in new and creative applications."
According to the Centers for Disease Control (CDC), 25% of pregnant women may be colonized with Group B Strep. If colonized mothers give birth before antibiotics can be administered, the bacteria can be passed to the newborn and cause life-threatening blood infections, such as meningitis, sepsis, pneumonia, or even stillbirth. The U.S. CDC and World Health Organization (WHO) recommend all pregnant women worldwide be tested for Group B Strep between 35 and 37 weeks.
The rapid diagnostic tests from NanoLogix will benefit pregnant women who are deemed "at risk" for colonization of GBS at the time of delivery. With the need to wait only four hours for test results using NanoLogix test kits, physicians will have the opportunity to make more rapid decisions about administering bacteria-specific antibiotics to patients. With this breakthrough, it will be possible to reduce the over-use of broad-spectrum antibiotics that contribute to the ever-increasing problem of antibiotic resistance.
"We are thrilled with the results of the research conducted at UTHSC - Houston and we thank Dr. Faro and the other physicians for their work," said NanoLogix CEO Bret Barnhizer. "This verification of the effectiveness of our BNP and BNF Quick Test technology should soon benefit countless women and newborns around the world. Once FDA approved and adopted, patients diagnosed with Group B Strep can receive rapid and specific antibiotic treatment, while many others will avoid treatment altogether as a direct result of the UTHSC research. With over 125 million births annually around the world, and 4 million births in the US alone, the potential market for a rapid, inexpensive, sensitive Group B Strep test is vast."
Both Nanologix BNP and BNF Quick Test kits were validated in the study for Group B Strep detection and identification. They are easy to use and require little training and minimal equipment (other than an incubator). This allows the tests to be administered in remote areas with limited resources and personnel. Additionally, the tests can be performed on a single specimen - which is not cost effective for PCR-related methods.
Findings of the study, along with Group B Strep data isolated directly from patient samples will be presented at the 78th annual meeting of the Central Association of Obstetricians and Gynecologists October 26-28, 2011.
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