NanoLogix Rapid Diagnostic Technologies Set to Enter Market Under FDA 510K-Exempt Status
August 21 2012 - 12:51AM
Business Wire
NanoLogix (Pink Sheets: NNLX), a biotechnology innovator in the
rapid detection and identification of live-threat bacteria and
microorganisms, announces it will begin commercialization of its
BNP (BioNanoPore) and BNF (BioNanoFilter) diagnostic kits under FDA
510K-exempt status. The first product to be marketed will be the
Petri-based BNP detection kit utilizing TSA media. Other nutrient
media will be available by special order. Recently completed
independent third-party research has demonstrated BNP diagnostic
kits to be two to ten times faster at live bacteria detection than
traditional methods. Following the BNP rollout, NanoLogix plans to
commercialize its BNF technology, which third-party research
documents as 18 to 72 times faster than conventional detection and
identification methods. The company also plans to develop
customized test kits for particular applications and client
partners.
To shorten bacterial detection time,
samples grown on the NanoLogix BNP membrane can be moved to the
staining plate. (Photo: Business Wire)
NanoLogix is also beginning sales of conventional TSA Petri
plates. Both BNP kits and NanoLogix TSA Petri plates will be
packaged in the company's proprietary inert-gas charged vacuum Flat
Packs. A major third-party laboratory has documented these Flat
Packs to have at least a one-year shelf life stored under normal
conditions, compared to the 3-month shelf life of traditional Petri
plates.
Peer-Reviewed Research Pending Publication
The results of two independent third-party research studies
using NanoLogix technology have been submitted by their respective
organizations to major peer-reviewed medical technology journals
for publication.
The first submission details the use of NanoLogix BNF test kits
and final results of a 356 pregnant-patient Group B Streptococcus
(GBS) clinical study at the University of Texas Health Science
Center - Houston. This study attained GBS detection, identification
and antibiotic-sensitivity results from samples collected in as
little a 6 hours, a sharp contrast to traditional laboratory test
times of 48-72 hours. One major goal in the study was to ensure the
ability to test for antibiotic sensitivity in reduced time from the
standard, potentially enabling physicians to rapidly tailor
antibiotics to the specific infection involved and reduce the
overuse of broad spectrum antibiotics. For more on GBS:
http://sites.conversionplanet.com/group-b-strep-awareness/group%20b%20strep/how-rapid-testing-can-change-the-diagnosis-and-treatment-of-gbs
The second submission features data from a major independent
laboratory documenting NanoLogix BNP test kits five-day detection
of live Tuberculosis. Traditional culture delivers results in 21-28
days.
About NanoLogix, Inc.
NanoLogix is a biotechnology company focused primarily on rapid
diagnostics. Its products offer accelerated detection and
identification of bacteria and other microorganisms. In addition to
medical and homeland security applications, NanoLogix technology is
applicable in pharmaceutical, industrial, veterinary and
environmental testing. For more information visit www.nanologix.com.
This press release contains statements, which may constitute
"forward- looking statements" within the meaning of the Securities
Act of 1933 and the Securities Exchange Act of 1934, as amended by
the Private Securities Litigation Reform Act of 1995. Those
statements include statements regarding the intent, belief or
current expectations of NanoLogix, Inc., and members of its
management as well as the assumptions on which such statements are
based. Prospective investors are cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties, and that actual results may
differ materially from those contemplated by such forward-looking
statements. The Company undertakes no obligation to update or
revise forward-looking statements to reflect changed assumptions,
the occurrence of unanticipated events or changes to future
operating results.
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