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
'/>"/>

SOURCE DxNA
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

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:3/4/2015)... 2015 The medical device landscape is ... forgot – or ignored or didn't know – the ... based on physician input before proceeding to design and ... founders – become so enamored of an innovative concept ... physicians use the device?” says Dr. Kathryn Stecco ...
(Date:3/3/2015)... On February 24, 2015, a Toledo, ... States District Court for the Northern District of Ohio ... as insurance companies Balboa, QBE, and Newport Management. (See ... 3:14-cv-152.) , The Plaintiff, a Ms. Dolores Gorsuch, says ... her to buy too much insurance at rates that ...
(Date:3/3/2015)... Chicago, IL (PRWEB) March 03, 2015 ... sits down with CARE Surrogacy Center for ... The interview originally appearing online is an exhilarating revelation ... details that have led him from Australia to the ... a recent press interchange, Tolga Umar, CEO and Founder ...
(Date:3/3/2015)... 03, 2015 Dan E. Chambers, an experienced ... focus on capital crimes, recently spoke on the radio to ... The hosts of the Independent Journal Review radio show “The ... first as a prosecutor and now as a criminal defense ... made in the trial and sentencing of this high-profile case. ...
(Date:3/3/2015)... The report “Alopecia – Pipeline Review, H1 ... Alopecia. Alopecia is the loss of hair. Alopecia areata ... alopecia. Causes for alopecia include aging, genetics, illness, chemotherapy, ... male pattern hair loss, female diffuse hair loss, hairs ... as focal or diffuse and by the presence or ...
Breaking Medicine News(10 mins):Health News:Want to Succeed in Medical Technology? Don't Innovate in a Vacuum 2Health News:Want to Succeed in Medical Technology? Don't Innovate in a Vacuum 3Health News:Borrower Accuses Mortgage Lenders of Racketeering in Forcing Insurance on Homeowners 2Health News:CARE Surrogacy Center Mexico Conducts Candid Interview with Australian Father of Twins 2Health News:CARE Surrogacy Center Mexico Conducts Candid Interview with Australian Father of Twins 3Health News:Dan E. Chambers Gives Radio Interview Providing Insights into American Sniper Guilty Verdict 2Health News:Dan E. Chambers Gives Radio Interview Providing Insights into American Sniper Guilty Verdict 3Health News:Alopecia Therapeutics Drugs and Companies Pipeline Market H1 2015 Review Report Available at RnRMarketResearch.com 2Health News:Alopecia Therapeutics Drugs and Companies Pipeline Market H1 2015 Review Report Available at RnRMarketResearch.com 3Health News:Alopecia Therapeutics Drugs and Companies Pipeline Market H1 2015 Review Report Available at RnRMarketResearch.com 4
... is celebrated the world over as the World Population Day. ... in 1988, to mark the occasion of the world population hitting ... of the day is to draw attention to issues related to ... to focus on the impact of the growing population on developmental ...
... joy it brings, pregnancy is also a harbinger of unwanted ... bothered by this condition, but a vast majority of them ... be a debilitating illness. Following a proper diet can take ... useful in pregnancy is Vitamin B6. Doctors do prescribe multi-vitamin ...
... plays an important role in the development of cancer. Protein ... cancer development//. , It is found that some ... titled The China Study which is published by Benbella Books ... of the existing relationship between nutrition and cancer risk is ...
... teddy bears can help Alzheimer's patients interact and communicate ... of doctors at Newcastle General Hospital studied the benefits ... a teddy bear from her son, reported the online ... Alzheimer's disease patients can lose their intellectual, social and ...
... at the University of California, San Diego have found that ... the mainland//, but lighter on the barrier islands to blend ... simple genetic mutation. ,Their discovery, detailed in the July ... first to demonstrate how a small change in a single ...
... 2006 global award as the "Outstanding Cancer Organisation" for its ... ,The award for the Tata Memorial Centre was ... Cancer Control in Washington DC., ,The Tata Memorial Hospital ... in February 1941., ,In 1952, the Indian Cancer Research ...
Cached Medicine News:Health News:'Young and their Reproductive Health' - Theme of World Population Day 2Health News:Too Much Of Animal Protein May Lead To Cancer 2Health News:Genetic Mutation in Mice Suggests Extinct Mammoth Had Light and Dark Fur 2Health News:Genetic Mutation in Mice Suggests Extinct Mammoth Had Light and Dark Fur 3
(Date:3/3/2015)... 03, 2015 Research and Markets ( ... "Blister Packaging Market in the US 2015-2019" report ... market in the US to grow at a CAGR ... is a form of high-visibility packaging that uses pre-formed ... packs comprise a base layer, made either of plastic ...
(Date:3/3/2015)... 3, 2015   Surefire Medical, Inc. ... comparing the Surefire Infusion System with an end ... metastatic liver cancer, using the Surefire resulted in ... agents, and with significantly decreased uptake in normal ... the Society of Interventional Radiology (SIR) ...
(Date:3/3/2015)... --   Clinical trials at ... Publications in peer reviewed journals Gastrointestinal Endoscopy ... diagnostic value of confocal laser endomicroscopy in treatment of ... across Asia   ... of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today ...
Breaking Medicine Technology:United States Blister Packaging Market 2015-2019 - Growing Demand in Pharmaceuticals Industry with Amcor, Bemis, MeadWestvaco & Sonoco Products Dominating 2Clinical Trial Comparing the Surefire Infusion Device to an End Hole Catheter Finds Surefire Increases Tumor Uptake and Decreases Non-Target Embolization In Every Patient, Multiple Liver Cancer Types 2Two New Publications From Leading Team in China Present Data From Large Clinical Trials Highlighting Advantages of Cellvizio in Diagnosis of Gastric and Esophageal Cancers 2Two New Publications From Leading Team in China Present Data From Large Clinical Trials Highlighting Advantages of Cellvizio in Diagnosis of Gastric and Esophageal Cancers 3Two New Publications From Leading Team in China Present Data From Large Clinical Trials Highlighting Advantages of Cellvizio in Diagnosis of Gastric and Esophageal Cancers 4
... NEW YORK, Oct. 8 Regeneron Pharmaceuticals, Inc. (Nasdaq: ... increased the size of its previously announced underwritten public ... shares and agreed to an indicative price of $28.00 ... sole book-running manager for the offering. The offering is ...
... Caremark (NYSE: CVS ) is leading the ... issues, with several recently introduced initiatives now set to ... and Chief Operating Officer Larry Merlo and other senior ... in New York City today. (Logo: http://photos.prnewswire.com/prnh/20090226/NE75914LOGO) ...
Cached Medicine Technology:Regeneron Increases Size of Public Offering of Common Stock 2Regeneron Increases Size of Public Offering of Common Stock 3CVS Caremark Ready to Support Patients and Payors Through Coming Era of Health Care Expansion 2CVS Caremark Ready to Support Patients and Payors Through Coming Era of Health Care Expansion 3
... with high Numerical Apertures, these objectives have ... throughout the visible spectrum from violet to ... entire 25mm field of view. They also ... plus resolving power at the theoretical limit ...
Zeiss offers a full range of filter sets for a variety of applications....
Standard 20x long working distance objectives for greater magnifications of your microtools....
... economical laboratory tissue culture microscope, the CKX41 ... their applications. Olympus has taken the modular ... Fluorescence can be used with an add-on ... be carried out on the CKX41 with ...
Medicine Products: