MIRAMAR, Fla.–(BUSINESS WIRE)–Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today appear that its subsidiary, Hema Analytic Systems, LLC dba NuGenerex Diagnostics (www.nugenerexdiagnostics.com), has filed an appliance for European Economic Area (EEA) CE Marking of its anew developed point-of-care platform, the Express II, in account of the commercialization of the accessory for the accelerated testing of syphilis antibodies as allotment of all-embracing analytic testing algorithms. This belvedere offers artlessness of analytic testing in a array of settings. The Express II belvedere is simple abundant for an alone to self-administer in aloofness and can accumulate affliction in the able medical setting. The Company ahead appear the filing of a conditional apparent for the Express II.
CE Marking signifies that articles awash in the EEA accept been adjourned to accommodated aerial safety, health, and ecology aegis requirements and ensures chargeless movement of articles aural the 30 EEA countries. This new assay, called the NGDx-Express Analysis for Syphilis Antibodies, is a accelerated independent analysis for the qualitative apprehension of syphilis treponemal antibodies in animal accomplished blood, serum, or plasma, and can be acclimated to accurately analyze primary, secondary, and abeyant syphilis in affiliation with analytic signs, accommodating history, and added class assays.
Currently, syphilis is in catching accommodation in best countries in the apple and is continuing to acceleration in abounding areas. This catching is actuality apprenticed by manual of the syphilis organism, Treponema pallidum, in male-to-male animal activity, workers, and added aerial accident groups. Of accurate accent is the boundless access of syphilis in bairn breed afterwards accretion from an adulterated mother. The aboriginal and accelerated testing and analysis of both the mother and the baby decidedly decreases the austere furnishings of syphilis in the baby and reduces abiding disabilities.
The NGDx-Express Analysis for Syphilis Antibodies is advised to be acclimated in medical settings such as university clinics, burning affliction centers, applicant clinics, physician offices, accessible bloom clinics and any medical ambience which utilizes accelerated testing procedures. The adopted sample is a distinct bead of claret acquired by a feel stick (or a heel-prick in newborns), but the analysis can additionally be performed with serum or claret samples in laboratories with after-effects accessible in 15-20 minutes.
The NGDx-Express Analysis for Syphilis Antibodies, based on the patent-pending Express II platform, is additionally advised to be acclimated for absolute home use by consumers in countries area self-testing is permitted. For self-administered testing, a bead of claret is acquired by a simple feel stick and placed anon assimilate the accessory afterwards which a diluent pod absolute development absorber is placed on the device.
Traditional syphilis analytic algorithms advance assays such as RPR (Rapid Claret Reagin) or VDRL (Venereal Disease Research Laboratory). These non-treponemal assays are non-specific and, if positive, do not consistently advertise that the activated accommodating has syphilis. As such, a absolute RPR or VDRL appraisal charge be followed by acknowledging class testing which is time arresting and expensive. Newer “reverse syphilis analytic algorithms” advance the apprehension of Treponema pallidum treponemal antigens as a analytic indicator of syphilis infection. The apprehension of awful specific treponemal antigens is apocalyptic of either primary syphilis, accessory syphilis, or abeyant syphilis and absolute patients can be advised appropriately based on the after-effects of these assays.
The NGDx-Express Analysis for Syphilis Antibodies is based aloft the apprehension of antibodies to treponemal antigens, and is accordingly awful specific and alluringly ill-fitted for bargain and accelerated point-of-care analysis of syphilis with after-effects accessible in 15-20 minutes.
Dr. Harold G. Haines, PhD, President of NuGenerex Diagnostics, stated: “We are admiring to advertise this EEA authoritative filing for the NGDx-Express Analysis for Syphilis Antibodies. With this antecedent filing we can now commence on the action of entering the European bazaar with this appraisal as an basic allotment of the all-embracing accomplishment to action ascent syphilis infections in all genitalia of the world. We are additionally alpha the action of FDA 510k authoritative acquiescence and the Analytic Class Improvement Amendments (CLIA) which will acquiesce us to access the US bazaar with our different accelerated syphilis assay.”
Dr. Jason B. Terrell MD, Chief Medical and Scientific Officer of Generex stated: “The syphilis catching is a above common accessible bloom concern. The filing for CE Marking represents a analytical advance in commercialization and we are now one footfall afterpiece to carrying this abundant bare analysis to millions of patients beyond the world.”
Cautionary Note Regarding Forward-Looking Statements
This absolution and articulate statements fabricated from time to time by Generex assembly in account of the aforementioned accountable amount may accommodate “forward-looking statements” aural the acceptation of the Private Securities Litigation Reform Act of 1995. These statements can be articular by anterior words such as “expects,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of agnate meaning, and by the actuality that they do not chronicle carefully to absolute or accepted facts. Advanced statements frequently are acclimated in discussing abeyant artefact applications, abeyant collaborations, artefact development activities, analytic studies, authoritative submissions and approvals, and agnate operating matters. Abounding factors may account absolute after-effects to alter from advanced statements, including inaccurate assumptions and a ample array of risks and uncertainties, some of which are accepted and others of which are not. Accepted risks and uncertainties accommodate those articular from time to time in the letters filed by Generex with the Securities and Exchange Commission, which should be advised calm with any advanced statement. No advanced account is a agreement of approaching after-effects or events, and one should abstain agreement disproportionate assurance on such statements. Generex undertakes no obligation to amend about any advanced statements, whether as a aftereffect of new information, approaching contest or otherwise. Generex claims the aegis of the safe anchorage for advanced statements that is independent in the Private Securities Litigation Reform Act.
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