Guest guest Posted August 20, 2004 Report Share Posted August 20, 2004 I got this from another Autoimmune list and thought you'd find it interesting...Pam Corgenix and Autoimmune Technologies Complete Development ofDiagnostic Product for Fibromyalgia------------------------------------------------------------Test Kit for Anti-Polymer Antibodies (APA) to Be Launched This Year ThroughCorgenix Distribution OrganizationWESTMINSTER, Colo., Aug. 19 /PRNewswire-FirstCall/ -- Corgenix MedicalCorporation (OTC Bulletin Board: CONX) announced today that it hascompleted the development of the APA ELISA test kit for diagnosingfibromyalgia. The product was developed under a Development andManufacturing Agreement with Autoimmune Technologies, LLC (Autoimmune), aNew Orleans biomedical company. The new product employs Autoimmune'spatented technology, and is expected to enter FDA clinical trials in theUnited States this September.The Development and Manufacturing Agreement provides Corgenix with theexclusive rights to manufacture the kit, which detects anti-polymerantibodies (APA) and serves as the first serum-based assay specific forfibromyalgia, a common pain and fatigue disorder. Corgenix andAutoimmune are collaborating on distribution of the product, and expectto launch the patented APA ELISA test kit this September in Europethrough Corgenix' international distribution network. Internationaldistribution will be coordinated by Corgenix' subsidiary in the UK. Theproduct will subsequently be available in the US if the FDA grantsregulatory clearance."Current data suggests that APA-positive fibromyalgia patients comprisethe majority of fibromyalgia patients," said , MD, Chairman andCEO of Corgenix. "This test is intended for use as an aid in thediagnosis of patients presenting with the symptoms and signs offibromyalgia syndrome, as an aid in differentiating fibromyalgia patientsfrom patients with other autoimmune diseases, and as an aid indetermining which fibromyalgia patients have an immune response that isassociated with their symptoms."Fibromyalgia Syndrome (FMS) is a common chronic disorder that afflictsmillions of individuals, primarily women. It appears to have multiplecauses. FMS signs and symptoms include widespread pain, specific painful"tender points," fatigue, stiffness, sleep disturbance, headache,depression, anxiety, cognitive problems and other symptoms. Not all ofthe symptoms are present in every patient, and each patient may havedifferent symptoms at different times. The American College ofRheumatology (ACR) criteria for fibromyalgia require that a patientmanifest localized pain in at least 11 of 18 possible tender points andhave a history of chronic widespread pain of greater than three months'duration. Clinical physicians often consider other symptoms as well whenmaking a diagnosis of FMS. However, all of the diagnostic criteria nowgenerally used for fibromyalgia are subjective, and this leads manypeople who aren't suffering from fibromyalgia to believe that FMS is apsychological disorder rather than a physical disorder."The APA Assay is the first specific clinical laboratory test forobjectively identifying fibromyalgia patients," said B. ,PhD, President and Chief Science Officer of Autoimmune Technologies."The APA ELISA test detects IgG anti-polymer antibodies in human serum.Research has shown that not only are these antibodies detected in themajority of fibromyalgia patients tested, but antibody titers alsocorrelate with the severity of symptoms in these patients."Between 2% and 5% of adult women in the US are believed to have receiveda diagnosis of fibromyalgia, but the total number of FMS sufferers mightbe far greater. Researchers have found that, although half of US womenhave none of the 18 possible fibromyalgia tender points, approximately20% of US women may have 6 or more of these tender points. Otherresearch has determined that the direct medical costs of fibromyalgia,which include patient visits to multiple physicians to obtain adiagnosis, may exceed more than $15 billion per year in the US alone.In discussing the potential market for the APA ELISA test kit in thecontext of these figures, Doug Simpson, President of Corgenix, said,"Although other laboratory markers exist, this is the only serum-basedlab test that specifically picks up fibromyalgia patients. Researchfindings to date strongly suggest that fibromyalgia in APA-positivepatients is associated with an abnormal immune system response. As aresult, we expect the APA ELISA test to be useful not only in helpingphysicians make an initial diagnosis of fibromyalgia but also inindicating to them which of their fibromyalgia patients might benefitfrom one or more of the many existing drugs or therapies that modulatethe immune system."Mr. Simpson went on to say, "This is a very important step forward forboth of our companies. Obtaining rights to this unique technologyrepresents an excellent strategic fit for Corgenix, and expands ourbusiness base in markets that we currently serve. We see a veryattractive market potential worldwide for this testing, and think thisbrings significant opportunity to our company. In addition, therelationship provides Autoimmune Technologies with access to a companywith a global network to distribute its unique technology to the worldmarkets. We are happy to be working with Corgenix in what we feel is avery important endeavor," said D. Charbonnet, CEO of Autoimmune."Not since the discovery of rheumatoid factors in the 1940s has alaboratory test had the potential to so dramatically change theperception of a medical disorder. Rheumatoid factors provided theearliest laboratory evidence that rheumatoid arthritis was a 'realdisease' and led to dramatic advances in treatment for it. We believethat the APA Assay has the ability to do the same thing for fibromyalgia,formally establishing fibromyalgia as a separate and distinct physicaldisease and leading to greatly improved patient outcomes."About CorgenixCorgenix is a leader in the development and manufacture of anti-Phospholipid test kits and other unique diagnostic products forcardiovascular disease and thrombotic risk, being the first on the marketwith an FDA cleared assay for anti-Cardiolipin (aCL). The company isbased in metropolitan Denver and is focused on the development ofspecialized diagnostic kits for immunology disorders, vascular diseasesand bone and joint diseases. Corgenix diagnostic products arecommercialized for use in clinical laboratories throughout the world.More information about the company can be found on its Web site,http://www.corgenix.com.Corgenix has previously announced a planned merger with GenesisBioventures, Inc., (Genesis), a biomedical corporation focusing on thedevelopment and marketing of novel diagnostics and therapeutics.About Autoimmune TechnologiesAutoimmune Technologies is a privately held early-stage biomedicalcompany based in New Orleans. Autoimmune has licensed severalproprietary breakthrough research discoveries, including the APA Assay,from Tulane University School of Medicine and is working to make themcommercially available to the medical community. More information aboutthe company can be found on its Web site, http://www.autoimmune.com.Statements in this press release that are not strictly historical factsare "forward looking" statements (identified by the words "believe,""estimate," "project," "expect" or similar expressions) within themeaning of the Private Securities Litigation Reform Act of 1995. Thesestatements inherently involve risks and uncertainties that could causeactual results to differ materially from the forward-looking statements.Factors that would cause or contribute to such differences include, butare not limited to, continued acceptance of the Company's products andservices in the marketplace, competitive factors, changes in theregulatory environment, and other risks detailed in the Company'speriodic report filings with the Securities and Exchange Commission.The statements in this press release are made as of today, based uponinformation currently known to management, and the company does notundertake any obligation to publicly update or revise any forward-lookingstatements.--------© 2004 PR Newswire NASH Website http://www.liver-nash.com/ Join NASH-Non-Alcoholic-Steatohepatitis-subscribe Unsubscribe NASH-Non-Alcoholic-Steatohepatitis-unsubscribe Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 20, 2004 Report Share Posted August 20, 2004 Thanks, Pam! With my luck I'll probably fall in the "not normal but not specific for" category again, but it will certainly be nice to speed up diagnosis and to know to look for something else if it isn't positive. Kathy Fibro I got this from another Autoimmune list and thought you'd find it interesting...Pam Corgenix and Autoimmune Technologies Complete Development ofDiagnostic Product for Fibromyalgia------------------------------------------------------------Test Kit for Anti-Polymer Antibodies (APA) to Be Launched This Year ThroughCorgenix Distribution OrganizationWESTMINSTER, Colo., Aug. 19 /PRNewswire-FirstCall/ -- Corgenix MedicalCorporation (OTC Bulletin Board: CONX) announced today that it hascompleted the development of the APA ELISA test kit for diagnosingfibromyalgia. The product was developed under a Development andManufacturing Agreement with Autoimmune Technologies, LLC (Autoimmune), aNew Orleans biomedical company. The new product employs Autoimmune'spatented technology, and is expected to enter FDA clinical trials in theUnited States this September.The Development and Manufacturing Agreement provides Corgenix with theexclusive rights to manufacture the kit, which detects anti-polymerantibodies (APA) and serves as the first serum-based assay specific forfibromyalgia, a common pain and fatigue disorder. Corgenix andAutoimmune are collaborating on distribution of the product, and expectto launch the patented APA ELISA test kit this September in Europethrough Corgenix' international distribution network. Internationaldistribution will be coordinated by Corgenix' subsidiary in the UK. Theproduct will subsequently be available in the US if the FDA grantsregulatory clearance."Current data suggests that APA-positive fibromyalgia patients comprisethe majority of fibromyalgia patients," said , MD, Chairman andCEO of Corgenix. "This test is intended for use as an aid in thediagnosis of patients presenting with the symptoms and signs offibromyalgia syndrome, as an aid in differentiating fibromyalgia patientsfrom patients with other autoimmune diseases, and as an aid indetermining which fibromyalgia patients have an immune response that isassociated with their symptoms."Fibromyalgia Syndrome (FMS) is a common chronic disorder that afflictsmillions of individuals, primarily women. It appears to have multiplecauses. FMS signs and symptoms include widespread pain, specific painful"tender points," fatigue, stiffness, sleep disturbance, headache,depression, anxiety, cognitive problems and other symptoms. Not all ofthe symptoms are present in every patient, and each patient may havedifferent symptoms at different times. The American College ofRheumatology (ACR) criteria for fibromyalgia require that a patientmanifest localized pain in at least 11 of 18 possible tender points andhave a history of chronic widespread pain of greater than three months'duration. Clinical physicians often consider other symptoms as well whenmaking a diagnosis of FMS. However, all of the diagnostic criteria nowgenerally used for fibromyalgia are subjective, and this leads manypeople who aren't suffering from fibromyalgia to believe that FMS is apsychological disorder rather than a physical disorder."The APA Assay is the first specific clinical laboratory test forobjectively identifying fibromyalgia patients," said B. ,PhD, President and Chief Science Officer of Autoimmune Technologies."The APA ELISA test detects IgG anti-polymer antibodies in human serum.Research has shown that not only are these antibodies detected in themajority of fibromyalgia patients tested, but antibody titers alsocorrelate with the severity of symptoms in these patients."Between 2% and 5% of adult women in the US are believed to have receiveda diagnosis of fibromyalgia, but the total number of FMS sufferers mightbe far greater. Researchers have found that, although half of US womenhave none of the 18 possible fibromyalgia tender points, approximately20% of US women may have 6 or more of these tender points. Otherresearch has determined that the direct medical costs of fibromyalgia,which include patient visits to multiple physicians to obtain adiagnosis, may exceed more than $15 billion per year in the US alone.In discussing the potential market for the APA ELISA test kit in thecontext of these figures, Doug Simpson, President of Corgenix, said,"Although other laboratory markers exist, this is the only serum-basedlab test that specifically picks up fibromyalgia patients. Researchfindings to date strongly suggest that fibromyalgia in APA-positivepatients is associated with an abnormal immune system response. As aresult, we expect the APA ELISA test to be useful not only in helpingphysicians make an initial diagnosis of fibromyalgia but also inindicating to them which of their fibromyalgia patients might benefitfrom one or more of the many existing drugs or therapies that modulatethe immune system."Mr. Simpson went on to say, "This is a very important step forward forboth of our companies. Obtaining rights to this unique technologyrepresents an excellent strategic fit for Corgenix, and expands ourbusiness base in markets that we currently serve. We see a veryattractive market potential worldwide for this testing, and think thisbrings significant opportunity to our company. In addition, therelationship provides Autoimmune Technologies with access to a companywith a global network to distribute its unique technology to the worldmarkets. We are happy to be working with Corgenix in what we feel is avery important endeavor," said D. Charbonnet, CEO of Autoimmune."Not since the discovery of rheumatoid factors in the 1940s has alaboratory test had the potential to so dramatically change theperception of a medical disorder. Rheumatoid factors provided theearliest laboratory evidence that rheumatoid arthritis was a 'realdisease' and led to dramatic advances in treatment for it. We believethat the APA Assay has the ability to do the same thing for fibromyalgia,formally establishing fibromyalgia as a separate and distinct physicaldisease and leading to greatly improved patient outcomes."About CorgenixCorgenix is a leader in the development and manufacture of anti-Phospholipid test kits and other unique diagnostic products forcardiovascular disease and thrombotic risk, being the first on the marketwith an FDA cleared assay for anti-Cardiolipin (aCL). The company isbased in metropolitan Denver and is focused on the development ofspecialized diagnostic kits for immunology disorders, vascular diseasesand bone and joint diseases. Corgenix diagnostic products arecommercialized for use in clinical laboratories throughout the world.More information about the company can be found on its Web site,http://www.corgenix.com.Corgenix has previously announced a planned merger with GenesisBioventures, Inc., (Genesis), a biomedical corporation focusing on thedevelopment and marketing of novel diagnostics and therapeutics.About Autoimmune TechnologiesAutoimmune Technologies is a privately held early-stage biomedicalcompany based in New Orleans. Autoimmune has licensed severalproprietary breakthrough research discoveries, including the APA Assay,from Tulane University School of Medicine and is working to make themcommercially available to the medical community. More information aboutthe company can be found on its Web site, http://www.autoimmune.com.Statements in this press release that are not strictly historical factsare "forward looking" statements (identified by the words "believe,""estimate," "project," "expect" or similar expressions) within themeaning of the Private Securities Litigation Reform Act of 1995. Thesestatements inherently involve risks and uncertainties that could causeactual results to differ materially from the forward-looking statements.Factors that would cause or contribute to such differences include, butare not limited to, continued acceptance of the Company's products andservices in the marketplace, competitive factors, changes in theregulatory environment, and other risks detailed in the Company'speriodic report filings with the Securities and Exchange Commission.The statements in this press release are made as of today, based uponinformation currently known to management, and the company does notundertake any obligation to publicly update or revise any forward-lookingstatements.--------© 2004 PR Newswire NASH Website http://www.liver-nash.com/ Join NASH-Non-Alcoholic-Steatohepatitis-subscribe Unsubscribe NASH-Non-Alcoholic-Steatohepatitis-unsubscribe Please visit our website at:http://ACES_Autoimmune.tripod.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 20, 2004 Report Share Posted August 20, 2004 Thanks, Pam! With my luck I'll probably fall in the "not normal but not specific for" category again, but it will certainly be nice to speed up diagnosis and to know to look for something else if it isn't positive. Kathy Fibro I got this from another Autoimmune list and thought you'd find it interesting...Pam Corgenix and Autoimmune Technologies Complete Development ofDiagnostic Product for Fibromyalgia------------------------------------------------------------Test Kit for Anti-Polymer Antibodies (APA) to Be Launched This Year ThroughCorgenix Distribution OrganizationWESTMINSTER, Colo., Aug. 19 /PRNewswire-FirstCall/ -- Corgenix MedicalCorporation (OTC Bulletin Board: CONX) announced today that it hascompleted the development of the APA ELISA test kit for diagnosingfibromyalgia. The product was developed under a Development andManufacturing Agreement with Autoimmune Technologies, LLC (Autoimmune), aNew Orleans biomedical company. The new product employs Autoimmune'spatented technology, and is expected to enter FDA clinical trials in theUnited States this September.The Development and Manufacturing Agreement provides Corgenix with theexclusive rights to manufacture the kit, which detects anti-polymerantibodies (APA) and serves as the first serum-based assay specific forfibromyalgia, a common pain and fatigue disorder. Corgenix andAutoimmune are collaborating on distribution of the product, and expectto launch the patented APA ELISA test kit this September in Europethrough Corgenix' international distribution network. Internationaldistribution will be coordinated by Corgenix' subsidiary in the UK. Theproduct will subsequently be available in the US if the FDA grantsregulatory clearance."Current data suggests that APA-positive fibromyalgia patients comprisethe majority of fibromyalgia patients," said , MD, Chairman andCEO of Corgenix. "This test is intended for use as an aid in thediagnosis of patients presenting with the symptoms and signs offibromyalgia syndrome, as an aid in differentiating fibromyalgia patientsfrom patients with other autoimmune diseases, and as an aid indetermining which fibromyalgia patients have an immune response that isassociated with their symptoms."Fibromyalgia Syndrome (FMS) is a common chronic disorder that afflictsmillions of individuals, primarily women. It appears to have multiplecauses. FMS signs and symptoms include widespread pain, specific painful"tender points," fatigue, stiffness, sleep disturbance, headache,depression, anxiety, cognitive problems and other symptoms. Not all ofthe symptoms are present in every patient, and each patient may havedifferent symptoms at different times. The American College ofRheumatology (ACR) criteria for fibromyalgia require that a patientmanifest localized pain in at least 11 of 18 possible tender points andhave a history of chronic widespread pain of greater than three months'duration. Clinical physicians often consider other symptoms as well whenmaking a diagnosis of FMS. However, all of the diagnostic criteria nowgenerally used for fibromyalgia are subjective, and this leads manypeople who aren't suffering from fibromyalgia to believe that FMS is apsychological disorder rather than a physical disorder."The APA Assay is the first specific clinical laboratory test forobjectively identifying fibromyalgia patients," said B. ,PhD, President and Chief Science Officer of Autoimmune Technologies."The APA ELISA test detects IgG anti-polymer antibodies in human serum.Research has shown that not only are these antibodies detected in themajority of fibromyalgia patients tested, but antibody titers alsocorrelate with the severity of symptoms in these patients."Between 2% and 5% of adult women in the US are believed to have receiveda diagnosis of fibromyalgia, but the total number of FMS sufferers mightbe far greater. Researchers have found that, although half of US womenhave none of the 18 possible fibromyalgia tender points, approximately20% of US women may have 6 or more of these tender points. Otherresearch has determined that the direct medical costs of fibromyalgia,which include patient visits to multiple physicians to obtain adiagnosis, may exceed more than $15 billion per year in the US alone.In discussing the potential market for the APA ELISA test kit in thecontext of these figures, Doug Simpson, President of Corgenix, said,"Although other laboratory markers exist, this is the only serum-basedlab test that specifically picks up fibromyalgia patients. Researchfindings to date strongly suggest that fibromyalgia in APA-positivepatients is associated with an abnormal immune system response. As aresult, we expect the APA ELISA test to be useful not only in helpingphysicians make an initial diagnosis of fibromyalgia but also inindicating to them which of their fibromyalgia patients might benefitfrom one or more of the many existing drugs or therapies that modulatethe immune system."Mr. Simpson went on to say, "This is a very important step forward forboth of our companies. Obtaining rights to this unique technologyrepresents an excellent strategic fit for Corgenix, and expands ourbusiness base in markets that we currently serve. We see a veryattractive market potential worldwide for this testing, and think thisbrings significant opportunity to our company. In addition, therelationship provides Autoimmune Technologies with access to a companywith a global network to distribute its unique technology to the worldmarkets. We are happy to be working with Corgenix in what we feel is avery important endeavor," said D. Charbonnet, CEO of Autoimmune."Not since the discovery of rheumatoid factors in the 1940s has alaboratory test had the potential to so dramatically change theperception of a medical disorder. Rheumatoid factors provided theearliest laboratory evidence that rheumatoid arthritis was a 'realdisease' and led to dramatic advances in treatment for it. We believethat the APA Assay has the ability to do the same thing for fibromyalgia,formally establishing fibromyalgia as a separate and distinct physicaldisease and leading to greatly improved patient outcomes."About CorgenixCorgenix is a leader in the development and manufacture of anti-Phospholipid test kits and other unique diagnostic products forcardiovascular disease and thrombotic risk, being the first on the marketwith an FDA cleared assay for anti-Cardiolipin (aCL). The company isbased in metropolitan Denver and is focused on the development ofspecialized diagnostic kits for immunology disorders, vascular diseasesand bone and joint diseases. Corgenix diagnostic products arecommercialized for use in clinical laboratories throughout the world.More information about the company can be found on its Web site,http://www.corgenix.com.Corgenix has previously announced a planned merger with GenesisBioventures, Inc., (Genesis), a biomedical corporation focusing on thedevelopment and marketing of novel diagnostics and therapeutics.About Autoimmune TechnologiesAutoimmune Technologies is a privately held early-stage biomedicalcompany based in New Orleans. Autoimmune has licensed severalproprietary breakthrough research discoveries, including the APA Assay,from Tulane University School of Medicine and is working to make themcommercially available to the medical community. More information aboutthe company can be found on its Web site, http://www.autoimmune.com.Statements in this press release that are not strictly historical factsare "forward looking" statements (identified by the words "believe,""estimate," "project," "expect" or similar expressions) within themeaning of the Private Securities Litigation Reform Act of 1995. Thesestatements inherently involve risks and uncertainties that could causeactual results to differ materially from the forward-looking statements.Factors that would cause or contribute to such differences include, butare not limited to, continued acceptance of the Company's products andservices in the marketplace, competitive factors, changes in theregulatory environment, and other risks detailed in the Company'speriodic report filings with the Securities and Exchange Commission.The statements in this press release are made as of today, based uponinformation currently known to management, and the company does notundertake any obligation to publicly update or revise any forward-lookingstatements.--------© 2004 PR Newswire NASH Website http://www.liver-nash.com/ Join NASH-Non-Alcoholic-Steatohepatitis-subscribe Unsubscribe NASH-Non-Alcoholic-Steatohepatitis-unsubscribe Please visit our website at:http://ACES_Autoimmune.tripod.com Quote Link to comment Share on other sites More sharing options...
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