AACC 2016 Corgenix/ORGENTEC feature combined company’s instruments and test kits

At the 2016 AACC Clinical Lab Expo August 2-4, Philadelphia PA, Corgenix and ORGENTEC company combined to exhibit their unique brand of products. ORGENTEC, a global specialty diagnostic company, highlighting its broad menu of more than 350 diagnostic tests including autoimmune, cardiovascular, infectious diseases and organ function assays. The Alegria® Analyzer is trusted in more than 1,000 placements around the world to improve lab accuracy and productivity while increasing flexibility in rare-disease testing, even for small labs. CORGENIX, a unique brand of quality and highlighting their autoimmune and cardiovascular offerings, including the AspirinWorks® test, the world’s only urine test for measuring thromboxane metabolites to determine aspirin effect. CORGENIX is also recognized as a superior partner in the industry for its contract R&D and contract manufacturing services and would welcome inquiries about its capabilities.

ORGENTEC and Corgenix Present Abstracts at 2015 AACC Clinical Lab Expo

Three Ebola research abstracts and heart disease risk abstract highlight Corgenix science presentations at AACC Expo

 CHICAGO — July 24, 2015 — Corgenix Medical Corporation, the U.S. – based operation of ORGENTEC Diagnostika, is presenting several scientific abstracts at the 2015 American Association for Clinical Chemistry (AACC) Clinical Lab Expo in Atlanta. Three abstracts involve the ReEBOV® Ebola rapid diagnostic test (RDT) with a fourth abstract involving the AtherOx™ Assay for assessing heart disease risk.

On July 28 in the AACC Clinical Studies/Outcomes session, Corgenix will present poster A-003 “Clinical validation of the ReEBOV Antigen Rapid Test Kit for the point of care detection of Ebola Virus Disease.” On July 29, Corgenix will present two posters during the Infectious Disease session: poster B-074 “Analytical validation of the ReEBOV Antigen Rapid Test Kit for the point of care detection of Ebola Virus Disease;” and poster B-072 “Preliminary validation of saliva samples as clinical matrix on the ReEBOV Antigen Rapid Test Kit for the point of care detection of Ebola Virus Disease.” In the Lipids/Lipoproteins session, Corgenix will present poster B-125 “The AtherOx™ Assay detects oxLDL-β2GPI antigen complexes associated with atherosclerotic vascular disease.”

The Corgenix ReEBOV Ebola rapid test was the first RDT and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus. In February 2015, it was also listed as eligible for procurement by the World Health Organization in the fight against the West Africa Ebola outbreak. Corgenix’ patented AtherOx technology was recently incorporated into the Health Diagnostic Laboratory Inc. (HDL Inc.) Oxidized LDL (oxLDL-β2GPI) heart disease risk test.

“We’re proud of the groundbreaking research that our Corgenix team is presenting at AACC this year,” said Werner Hofacher, CEO, ORGENTEC. “This work reflects our combined commitment to improving science, serving the patient and positively impacting global health care.”

The combined ORGENTEC-Corgenix specialty diagnostics company exhibiting in Clinical Lab Expo booth #3711 boasts a portfolio of more than 350 diagnostic tests, including ELISA, IFA, LFI, IT and immunoblot. ORGENTEC completed its acquisition of Corgenix Medical Corporation in March 2015 and is exhibiting for the first time at AACC. ORGENTEC-Corgenix representatives will be available throughout the expo to discuss capabilities and answer questions about the new company.

The following restrictions apply to the Corgenix ReEBOV Ebola rapid test:

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an Emergency Use Authorization for use by laboratories and facilities adequately equipped, trained and capable of testing for Ebola infection (including treatment centers and public health clinics);
  • This test has been authorized only for the detection of Ebola viruses (including Ebola Zaire virus detected in the West Africa outbreak in 2014);
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About ORGENTEC

Headquartered in Mainz, Germany, with U.S. operations in Broomfield, Colorado, ORGENTEC offers one of the industry’s most comprehensive portfolios in autoimmune diagnostics and cardiovascular diagnostics with additional strengths in infectious disease, inflammatory rheumatic diseases, thrombotic disorders and organ function testing. The company’s products are supported by a global distribution network, and its line of automated instruments for diagnostics and serology enables labs to complete multiple assays and deliver faster results than traditional analyzers. Additionally, ORGENTEC contract develops and manufactures products for key medical and life science companies.

 To learn more about this exciting new development in specialty diagnostics, visit us at booth #3711. For more information on ORGENTEC, visit www.ORGENTEC.com or call +49 6131 / 9258-0; for more information on Corgenix, visit www.corgenix.com or call 303.457.4345 ext. 351.

 

Company Contact:

ORGENTEC-Corgenix

Ann Steinbarger

Phone: 303-453-8951

Email: asteinbarger@corgenix.com

 

Media Contact:

Armada Medical Marketing

Dan Snyders, Vice President and Public Relations Supervisor
Phone: 303-623-1190 x230

Email: dan@armadamedical.com

ORGENTEC and Corgenix Launch Combined Operations at 2015 AACC Clinical Lab Expo

CHICAGO — July 15, 2015 — The global diagnostics industry is welcoming ORGENTEC-Corgenix to the 2015 American Association of Clinical Chemistry (AACC) Clinical Lab Expo in booth #3711. ORGENTEC-Diagnostika completed its acquisition of Corgenix Medical Corporation in March 2015 and is exhibiting for the first time at AACC. The combined specialty diagnostics company boasts a portfolio of more than 350 diagnostic tests, including ELISA, IFA, LFI, IT and immunoblot.

“The AACC conference marks a new and promising beginning for our companies,” said Werner Hofacher, CEO of the combined ORGENTEC-Corgenix. “Both companies are highly innovative with unique offerings that almost perfectly complement each other. Together, we’ll work on our strategic plan to build ORGENTEC-Corgenix into the global industry leader in specialty diagnostics.”

ORGENTEC excels in autoimmune diagnostics with additional capabilities in specialty infectious disease and organ function testing. Corgenix offers an extensive cardiovascular diagnostics portfolio along with autoimmune, organ function and infectious disease testing.

Corgenix has achieved global recognition for its development of the AspirinWorksÒ Test – the world’s only urine-based test for measuring aspirin effect – and for its Ebola and Lassa rapid diagnostic tests developed in collaboration with the Viral Hemorrhagic Fever Consortium.

“We believe in improving global health care through the development of innovative diagnostic tests targeting a range of conditions, and we look forward to expanding our offerings to even more laboratories, hospitals and patients worldwide,” said Hofacher.

According to Hofacher, exhibiting at the AACC Clinical Lab expo enables ORGENTEC-Corgenix to personally demonstrate the value of the combined operation to current and prospective customers and solidify relationships with strategic partners.

ORGENTEC-Corgenix representatives will be available throughout the expo at booth #3711 to discuss capabilities and answer questions about the new company. Several scientific posters in the infectious disease category will be presented by ORGENTEC-Corgenix researchers; consult the AACC 2015 conference program for full details.

 

About ORGENTEC

Headquartered in Mainz, Germany, with U.S. operations in Broomfield, Colorado, ORGENTEC offers one of the industry’s most comprehensive portfolios in autoimmune diagnostics and cardiovascular diagnostics with additional strengths in infectious disease, inflammatory rheumatic diseases, thrombotic disorders and organ function testing. The company’s products are supported by a global distribution network, and its line of automated instruments for diagnostics and serology enables labs to complete multiple assays and deliver faster results than traditional analyzers. Additionally, ORGENTEC contract develops and manufactures products for key medical and life science companies.

 

To learn more about this exciting new development in specialty diagnostics, visit us at booth #3711. For more information on ORGENTEC, visit www.ORGENTEC.com or call +49 6131 / 9258-0; for more information on Corgenix, visit www.corgenix.com or call 303.457.4345 ext. 180.

 

Company Contact:

ORGENTEC-Corgenix

Ann Steinbarger

Phone: 303-453-8951

Email: asteinbarger@corgenix.com

 

Media Contact:

Armada Medical Marketing

Dan Snyders, Vice President and Public Relations Supervisor
Phone: 303-623-1190 x230

Email: dan@armadamedical.com

Corgenix Transfers to ORGENTEC Exclusive Worldwide Distribution Rights. Effective July 1st

DENVERJune 3, 2015 —We are pleased to announce that ORGENTEC Diagnostika has finalized its acquisition of Corgenix Inc.

As a result, the Corgenix product range has transferred to ORGENTEC now holding the exclusive worldwide distribution rights. Effective July 1st, please direct orders and inquiries for Corgenix products to ORGENTEC who will be happy to handle your inquiries (or refer you to the appointed local distributor, if applicable). Be assured that we will do our best to keep supply seamless. ORGENTEC and Corgenix will work hard to earn your trust and loyalty.
If you have any questions, please contact us. Your ORGENTEC and Corgenix International Commercial Team

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Corgenix and Fio Combine Rapid Ebola Test with Automated Analysis and Data Capture to Improve Frontline Care and Case Tracking

Collaboration leverages Bill & Melinda Gates Foundation and Paul G. Allen Family Foundation grants to automate rapid Ebola testing and increase access to reliable data from the field

DENVER and TORONTOMarch 10, 2015Corgenix Medical Corporation (OTC QB: CONX.OB) and Fio Corporation today announced that they are working together to integrate two technological advances to help end the Ebola outbreak in West Africa: a rapid test, backed by the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation, that can detect the virus in minutes; and a mobile device, which is being adapted with further funding from the Gates Foundation, to analyze and upload results directly to a central data system.

Fio is adapting its Deki™ Reader to work with the Corgenix ReEBOVTM Antigen Rapid Test for the Ebola virus, which recently received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and was listed as eligible for procurement by the World Health Organization (WHO). Combining these technologies will give suspected Ebola patients in the most remote, resource-poor settings, access to automated test results. Results will then immediately be transmitted to Fio’s data system, Fionet™, capturing vital information that is currently missed or delayed.

“This collaboration makes testing more accessible to those at risk and data more readily available to those managing the outbreak, a combination that the Gates Foundation identified and mobilized,” said Dr. Michael M. Greenberg, chairman and CEO of Fio. “The resulting technology will expand the capability to fight Ebola now and strengthen national health systems beyond the current crisis.”

Corgenix researchers on the ground in Sierra Leone have already started using smartphones to transmit images of rapid Ebola test results to the Fionet data system. Together with Fio’s tools for case and contact mapping, this capability offers governments and other organizations responding to the outbreak a way to track the disease in real time.

“We’re taking the fight against Ebola to another level with Fio’s data collection and management, which is critical to the success of rapid testing,” said Douglass Simpson, Corgenix president and CEO. “This marks a tremendous advancement in Ebola testing, and it lays the groundwork for a strong and productive partnership between our two companies on future projects.”

The instant traceability of infected or potentially infected individuals – knowing test results, locations and movement over time and across borders – is essential to containing the spread of the Ebola virus and other highly contagious diseases.

Both companies will continue to work together to integrate the two technologies for decentralized Ebola virus testing throughout West Africa. Beyond the current crisis, this will serve health systems more broadly to better manage future outbreaks, as well as other infectious diseases in the region, such as Lassa virus.

Fio’s Deki Reader – which is already CE-marked for use with rapid tests that detect malaria and dengue fever – is also being adapted for use with the Corgenix ReLASV® Antigen Rapid Test for the Lassa virus.

Fio received a Gates Foundation grant in December 2014 to adapt its Deki Reader to analyze rapid Ebola tests and transmit results to Fionet to be integrated with case and contact management tools.

A few weeks later, Corgenix received two grants – one from the Gates Foundation and one from the Paul G. Allen Family Foundation – to advance the company’s development of an Ebola rapid test kit.

Both the ReLASV® Antigen Rapid Test and the ReEBOVTM Antigen Rapid Test have not been cleared for routine diagnostic use by the US Food and Drug Administration.

The ReLASV® Antigen Rapid Test is CE Marked for diagnostic use in EU and other countries that recognize the CE mark.

The ReEBOVTM Antigen Rapid Test is not CE Marked and may only be used as a diagnostic device under the conditions of the Emergency Use Authorization issued by the US Food and Drug Administration.

 About Fio Corporation

Operating at the nexus of care delivery and data, Fio is focused on decentralized management of infectious diseases in developed and developing countries alike. Fio helps health workers of all skill levels improve the quality of care they provide to individual patients, while automatically capturing and disseminating data to strengthen health systems as a whole. Fio’s solution combines mobile intelligent devices with cloud information services to facilitate healthcare delivery that drives, rather than competes with, data capture. Fio is headquartered in Toronto, Canada, with commercial operations underway in Latin America, Africa and Europe.

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience in product submissions to the FDA and other worldwide regulatory authorities. Additionally, Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com (Corporate website) and www.corgenix.net (Contract Services website).

Statements in this press release that are not strictly historical facts are “forward-looking” statements (identified by the words “believe”, “estimate”, “project”, “expect” or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.

Corgenix Company Contact:

Corgenix Medical Corp.

William Critchfield, Senior VP Operations and Finance and CFO

Phone: 303-453-8903

Email: wcritchfield@corgenix.com

 

Corgenix Media Contact:

Armada Medical Marketing

Dan Snyders, Vice President and Public Relations Supervisor

Phone: 303-623-1190 x230

Email: dan@armadamedical.com

 

Fio Corporation Media Contacts:

Asher Greenberg, Project Coordinator and Communications Officer

Phone: +1 416-309-2706

Email: agreenberg@fio.com

 

Marlee Wasser, Communications Consultant

Phone: +1 416-799-3714

Email: mwasser@fio.com

 

The Bill & Melinda Gates Foundation can be reached for comment at: media@gatesfoundation.org

Corgenix Receives FDA Authorization and WHO Listing for Emergency Use of Ebola Rapid Diagnostic Test

DENVERFebruary 26, 2015Corgenix Medical Corporation (OTC QB: CONX.OB), a worldwide developer and marketer of diagnostic test kits, announced it has received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) of its ReEBOVTM Antigen Rapid Test. The test is to be used for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in conjunction and with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection.)

The Corgenix Ebola rapid test is the first rapid diagnostic test (RDT) and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus. The EUA allows the use of the ReEBOVTM Antigen Rapid Test in circumstances when use of a rapid Ebola test is determined to be more appropriate than use of an authorized Ebola nucleic acid (molecular) test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The authorized ReEBOVTM Antigen Rapid Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing. 

Unlike molecular testing, which in West Africa can still take days to return results from central testing laboratories, the Corgenix RDT is a point-of-care test that can be used in any clinical facility adequately equipped, trained and capable of such testing, or in any field laboratory with trained personnel capable of such testing, to diagnose suspected Ebola cases in 15-25 minutes. The U.S. regulatory authorization follows last week’s World Health Organization (WHO) listing for procurement for the Corgenix Ebola RDT, making this test available to the health care community worldwide.

“The FDA and WHO have been working closely with us throughout this process to get this new test in the hands of those battling on the front lines of the Ebola outbreak as quickly as possible,” said Douglass Simpson, Corgenix President and CEO. “Completing this product development in less than a year demonstrates how governmental agencies, regulatory bodies, industry, non-profits and others can work together to find solutions to catastrophic events such as the Ebola virus outbreak. This collaboration has enabled us to quickly deliver this critically important point-of-care test and potential breakthrough in the fight against Ebola in the current outbreak in West Africa.”

Ebola is indigenous to Africa and is one of the deadliest viruses in the world, with mortality rates of between 30 and 90 percent. Ebola and other viral hemorrhagic fevers are difficult to discriminate because many of the early signs and symptoms are nonspecific and common to other infectious diseases such as Dengue fever, Lassa fever, typhoid and malaria.

“Corgenix’s work is crucial to addressing the Ebola outbreak in West Africa,” said United States Senator from Colorado Michael Bennet. “This new test has the potential to help medical officials in the field diagnose Ebola virus disease quicker than before to help control the spread of this vicious disease. We’re extremely grateful that this Colorado-based company has invested its resources and completed this research to develop such a valuable tool.”

The ReEBOVTM Antigen Rapid Test was developed by Corgenix in cooperation with additional members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University, including Autoimmune Technologies LLC, Zalgen Labs LLC, The Scripps Research Institute and the University of Texas Medical Branch at Galveston, as well as other collaborators in West Africa. Mr. Simpson noted, “We are pleased to be part of the VHFC. This is a remarkable group of scientists who have been in the forefront of research in Ebola, Lassa fever and other dangerous viral diseases in Africa for many years. A key component of our success is a result of the commitment and participation of the Ministry of Sanitation and Public Health of the Republic of Sierra Leone and the dedicated medical personnel of the Kenema Government Hospital in Kenema, Sierra Leone, a number of whom have died fighting the current Ebola outbreak.” 

“This has the potential to be a game-changer in stopping the spread of the epidemic,” said Dr. Robert Garry, Professor of Microbiology and Immunology at Tulane, and Principal Investigator of the VHFC. “Instead of taking days for lab results, the Ebola RDT uses a drop of blood from a finger prick to deliver a diagnosis in as little as 15 – 25 minutes, potentially allowing trained public health workers to isolate and treat patients immediately. Medical personnel will be able to quickly identify hotspots and may prevent resurgence of cases in the current outbreak.”

The FDA’s emergency use authorization of the ReEBOVTM Antigen Rapid Test is for the presumptive detection of Ebola viruses (including Ebola Zaire virus detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, including geographic location with high prevalence of Ebola infection. The test was also evaluated under WHO’s Emergency Use Assessment and Listing procedure, which provides independent technical information on safety, quality and performance of in vitro diagnostics, principally to other United Nations (UN) agencies but also to WHO Member States and other interested organizations in the context of the Ebola emergency.

Mr. Simpson stated that the VHFC will remain actively engaged in efforts to advance additional diagnostic products, some already under development for viral and parasitic diseases, and to expand collaborations with global health care partners, including providers in West Africa. The consortium has already developed a suite of additional laboratory assays to complement its RDTs. These additional assays are being developed to permit confirmation of point-of-care test results and augment much needed serosurveillance capabilities via ongoing and future seroprevalence studies on both Ebola and Lassa fever.

Development of the Corgenix ReEBOVTM Antigen Rapid Test for Ebola was supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) (grants 1R43AI088843 and 2R44AI088843). Additional support has been provided by The Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation. 

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network. Additionally, Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2003 certified and compliant with FDA regulations. More information is available at www.corgenix.com (Corporate website) and www.corgenix.net (Contract Services website).

About the Viral Hemorrhagic Fever Consortium

The Viral Hemorrhagic Fever Consortium was established as a result of numerous multi-year grants and contracts awarded to Tulane University by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to support Tulane’s ongoing efforts to diagnose, treat and prevent Lassa fever. The VHFC expanded its work into Ebola in 2010. The goal of the Consortium is to understand mechanisms related to the human immune response to viral infection. Specifically, by understanding what parts of the virus are recognized by the immune system, scientists can better understand mechanisms of antibody-mediated protection or pathogenesis in humans with Lassa fever, Ebola, and similar diseases. Consortium efforts have focused on the development of new recombinant proteins for diagnostic products, which have shown to be extremely effective in clinical settings in Africa. This progress is allowing a transition of efforts towards instituting better treatment of affected individuals and ultimately prevention of Lassa fever, Ebola, and other diseases altogether. The Consortium is a collaboration between Tulane, The Scripps Research Institute, the Broad Institute, Harvard University, the University of California at San Diego, the University of Texas Medical Branch at Galveston, Autoimmune Technologies LLC, Corgenix Medical Corporation, Zalgen Labs LLC, the Kenema Government Hospital (Sierra Leone), the Irrua Specialist Teaching Hospital and the Redeemer’s University Hospital (Nigeria), and various other partners in West Africa. More information is available at www.vhfc.org.

Statements in this press release that are not strictly historical facts are “forward-looking” statements (identified by the words “believe”, “estimate”, “project”, “expect” or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.

 

Company Contact:

Corgenix Medical Corp.
William Critchfield, Senior VP Operations and Finance and CFO
Phone: 303-453-8903
Email: wcritchfield@corgenix.com

Media Contact:

Armada Medical Marketing
Dan Snyders, Vice President and Public Relations Supervisor
Phone: 303-623-1190 x230
Email: dan@armadamedical.com

Corgenix Announces New Grants to Advance Work on Ebola Test Kit

Grants to support Ebola rapid test development awarded by the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation

DENVERDecember 24, 2014Corgenix Medical Corporation (OTC QB: CONX.OB), a worldwide developer and marketer of diagnostic test kits, has been awarded two grants totaling $818,000 to advance the development of an Ebola rapid diagnostic test kit.

The grants were awarded to Corgenix by the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation. Corgenix has selected three subcontractors to assist on the project: Tulane University, Autoimmune Technologies, LLC and Zalgen Labs, LLC.

“The scope and seriousness of Ebola virus outbreaks have resulted in an increased urgency to bring testing and products to market as soon as possible,” said Douglass Simpson, Corgenix president and CEO. “We thank the Gates and Allen foundations for their support and commitment to our efforts to accelerate the development of a rapid test.”   

The Corgenix point-of-care test kit currently under development is designed to be used in any clinical or field lab to determine in a matter of minutes if a patient is infected with Ebola. Corgenix and the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University and partially funded with support from the NIH, have already developed the ReLASV® rapid test for the Lassa fever virus. The Lassa product is CE marked as a diagnostic test, enabling its use as a diagnostic product in Europe and other countries that recognize the European standard.

“Accurate, rapid, point-of-care testing will be critical to helping contain future Ebola and Lassa virus outbreaks,” said Robert Garry, Ph.D., professor of Microbiology and Immunology at the Tulane University School of Medicine. “This grant will help ensure that our consortium develops this diagnostic testing tool as quickly as possible.”

Current testing for the Ebola virus requires special biohazard handling and sending test samples long distances to special labs – a process that takes several days. This results in a critical loss of time to diagnose, treat and help prevent the spread of the virus. Development of the Corgenix Ebola test would enable rapid response to public health and bioterrorism threats posed by the deadly virus.

The Corgenix Ebola products are not currently cleared or approved by any regulatory authority for diagnostic use.  

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience in product submissions to the FDA and other worldwide regulatory authorities. Additionally, Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com (Corporate website) and www.corgenix.net (Contract Services website).

Statements in this press release that are not strictly historical facts are “forward-looking” statements (identified by the words “believe”, “estimate”, “project”, “expect” or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.

Company Contact:

Corgenix Medical Corp.

William Critchfield, Senior VP Operations and Finance and CFO

Phone: 303-453-8903

Email: wcritchfield@corgenix.com

 

Media Contact:

Armada Medical Marketing

Dan Snyders, Vice President and Public Relations Supervisor
Phone: 303-623-1190 x230

Email: dan@armadamedical.com