Navigation Links
DxNA Submits its Rapid Detection Platform Test for H1N1 to FDA
Date:6/9/2009

Company's Portable 4.5kg "Lab in a Box" Allows for Rapid Onsite Pathogen Detection

ST. GEORGE, Utah, June 9 /PRNewswire/ -- DxNA announced today that it has submitted a request to the FDA for Emergency Use Authorization (EUA) for its GeneSTAT(R) pathogen platform, for the detection of the H1N1 virus (known as swine flu). EUA allows for the early availability of important diagnostic and therapeutics tools to diagnose, treat, or prevent critical or life-threatening diseases or conditions, when an alternative or approved solution is not available(1).

"Those touched by the flu are becoming increasingly aware that there is no accessible test for the H1N1 virus and that the currently available methods lack the capability to process large volumes of cases. We believe the availability of such a test would help assure concerned patients and families that they are taking the appropriate steps in combating this growing threat as cases continue to increase," said Phillip Grimm, Chief Executive Officer of DxNA. "This regulatory path provided by FDA allows early access to products with great potential like our GeneSTAT pathogen test platform, which we believe can provide a quick and efficient method to detect the H1N1 virus."

Although the period of review can vary by product profile, existing applications, and nature of the emergency, the FDA acts upon EUA submissions in an expedited manner to potentially bring life-changing diagnostic and therapeutic tools to the public.

DxNA has also developed a rapid, portable molecular test to detect H5 Avian Influenza for markets around the world. That test is now being validated by the Chinese government and other global health organizations.

The GeneSTAT(R) platform includes a portable device that offers remote usage to rapidly detect pathogens where outbreaks are suspected. The user-friendly device can be used in gateway airports, at local health departments and schools, where on-site rapid and non-invasive screening for highly contagious pathogens is advised. The GeneSTAT(R) test module requires a simple swab of the mouth, nose or throat. The Company is developing a number of follow-on tests to detect pathogens that may affect people and agriculture.

Through its rapid, precise, on-site polymerase chain reaction (PCR) genetic testing capabilities, GeneSTAT technology facilitates the rapid detection of pathogens and viruses. The World Health Organization has highlighted rapid detection of pandemics such as swine flu as "crucial" for the rapid implementation of measures "to stop the pandemic at its source and to prevent millions of deaths, social disruption, and economic loss(2)

About GeneSTAT(R)

DxNA's GeneSTAT diagnostic platform technology allows individuals with approximately five minutes of training to conduct accurate real-time diagnostic testing almost anywhere. With the GeneSTAT platform, PCR -- previously performed in large clinical laboratories by highly-skilled personnel -- can be performed by almost anyone, in virtually any location, including airports, laboratories, clinics, or physician's offices. Furthermore, testing is not limited to developed regions like the United States, Europe and Japan but also in less-developed rural and economically challenged regions. Designed with economy in mind, GeneSTAT is inherently less costly than the PCR devices typical of large clinical laboratories.

About DxNA

DxNA, based in St. George, Utah, and with offices in New York City is a groundbreaking molecular diagnostics company that develops and distributes portable, fully-integrated systems and tests for genetic analysis in the medical, agricultural, and biosecurity markets. The Company's systems and technologies enable rapid and precise genetic testing to take place on-site by allowing for otherwise complex, manual, laboratory procedures to be performed anywhere.

DxNA, together with its distinguished advisory board consisting of Nirbhay Kumar, Ph.D., Paul Blumenthal, M.D., M.P.H., Anthony R. Torres, M.D., and Richard Webby, Ph.D., is working to commercialize its GeneSTAT diagnostic technology for rapid PCR detection applications throughout the world. For more information, please visit www.DxNA.com.

(1) Emergency Use Authorization of Medical Products" Food and Drug Administration, July 2007, http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm

(2) "Global Surveillance During an Influenza Pandemic, Version 1" World Health Organization Global Influenza Programme, April 2009, http://www.who.int/csr/disease/swineflu/global_pandemic_influenza_surveilance_apr09.pdf (Accessed April 29, 2009)


'/>"/>
SOURCE DxNA
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
2. Global Med Technologies(R), Inc. Submits ElDorado Donor(TM) to FDA
3. Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application for Paliperidone Palmitate
4. SGX Pharmaceuticals Submits Investigational New Drug Application for SGX523, a Highly Potent, Selective, Orally Bioavailable cMET Inhibitor
5. ISTA Pharmaceuticals Submits New Drug Application for Xibrom(TM) QD (once-daily)
6. Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma
7. ImaRx Therapeutics Submits Urokinase Data to FDA Supporting Extended Expiration Dating
8. XTENT Submits CE Mark Registration to Market Custom NX(R) Drug-Eluting Stent System in Europe
9. Takeda submits new drug application for alogliptin (syr-322) in the US
10. Phyhealth Submits HMO Applications with Required Federal and State Agencies
11. Ethicon Endo-Surgery Submits Application to FDA for Approval of the SEDASYS(TM) System - the First Computer-Assisted Personalized Sedation System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... Austin, TX (PRWEB) , ... December 05, 2016 ... ... Center for Facial Plastic Surgery, is excited to announce the arrival of the ... hybrid fractional laser, with the ability to use tunable non-ablative and ablative wavelengths ...
(Date:12/5/2016)... ... , ... Researchers at Johns Hopkins All Children’s Hospital want to learn more ... course of three years, researchers will study concussions and changes in brain function by ... special sensors, will track the location and force of the hit. The sensors store ...
(Date:12/5/2016)... Nashville, Tennessee (PRWEB) , ... ... ... leader in strategic interoperability, today announced that the company will provide alerting ... platform. CIHIE has been recently awarded $1.7 million in federal funds as ...
(Date:12/5/2016)... ... ... Sideline Products is a Southern York County Pennsylvania-based premier designer and manufacturer founded ... Smaller saddles can pinch and irritate the horse creating safety issues and limiting comfort ... saddle so it does not impact the comfort or performance of the horse. Further, ...
(Date:12/5/2016)... ... 05, 2016 , ... The legislation – S2718A/A2116A ... a licensed physical therapist, to render care for certain patients. In most cases, ... a licensed physical therapist (PT) and throughout the treatment cycle is supported by ...
Breaking Medicine News(10 mins):
(Date:12/5/2016)... LAS VEGAS , Dec. 5, 2016  BD ... a leading global medical technology company, will demonstrate an ... BD medication management technologies, including the company,s leading Pyxis™ ... of Health-System Pharmacists (ASHP) 2016 Midyear Meeting being ... Dec. 4-8. While national data show that ...
(Date:12/5/2016)... Dec 5, 2016 Research and Markets has announced ... Global Forecast to 2021" report to their offering. ... , , The ... billion by 2021, at a CAGR of 5.3% from 2016 to 2021. ... of obesity cases, increasing government spending on healthcare, and rising income levels ...
(Date:12/5/2016)... Israel , December 5, 2016 ... identifying, in-licensing and developing promising therapeutic candidates, presents positive Phase ... BL-8040, the Company,s leading oncology platform at the ongoing 58th ... San Diego, California . ... , , ...
Breaking Medicine Technology: