LabCorp Introduces HCV Resistance Testing through Monogram Biosciences with the Launch of HCV GenoSure(R) NS3/4A
BURLINGTON, N.C., Aug 25, 2011 (BUSINESS WIRE) -- Laboratory Corporation of America(R) Holdings (LabCorp(R)) (NYSE: LH) announced today the nationwide availability of a nucleic acid sequencing assay that reports NS3 and NS4A mutations and NS3 associated resistance to the recently approved hepatitis C virus (HCV) protease inhibitors, adding to LabCorp's suite of HCV testing. Identification of certain mutations may be useful to clinicians considering patient treatment decisions.
"HCV GenoSure NS3/4A represents the first in a series of HCV drug resistance assays that have been developed at Monogram Biosciences to support the clinical evaluation of HCV direct-acting antiviral (DAA) agents and their use in the management of HCV infection," commented Chris Petropoulos, PhD, LabCorp's Vice President of Monogram Research & Development. "We look forward to expanding our broad HCV assay portfolio to support the development and clinical application of additional DAA agents that target other distinct steps in the HCV replication cycle."
HCV GenoSure NS3/4A is currently available exclusively through LabCorp and its Monogram Biosciences Center of Excellence. The test is available for commercial use as well as clinical trial use. Monogram is an established leader in anti-viral drug resistance with 15 years experience in virology and infectious disease testing.
An estimated 3.2 million people in the United States and up to 170 million people worldwide are infected by HCV. Since 2002, the standard of care for HCV infection in the US has been treatment with pegylated a-interferon and ribavirin. In May 2011, the FDA approved the first two DAA agents, boceprevir (Victrelis(TM), Merck & Co) and telaprevir (Incivek(TM), Vertex Pharmaceuticals). Either agent is used in combination with pegylated a-interferon and ribavirin for the treatment of HCV genotype 1 infection. During clinical trials conducted to support regulatory approval, HCV variants containing mutations that confer reduced susceptibility to boceprevir and telaprevir emerged in patients who experienced sub-optimal treatment response.
HCV GenoSure NS3/4A analyzes the genetic sequence for the non-structural proteins NS3 and NS4A of HCV genotypes 1a and 1b that encode for an enzyme essential to viral replication. The assay detects mutations in NS3 and NS4A and specifically identifies those associated with boceprevir and telaprevir resistance.
Recommendations recently developed by the HCV Drug Resistance Advisory Group emphasize the value of resistance testing at treatment baseline and failure in support of the development and clinical evaluation of new drug candidates. In HIV, the routine use of resistance testing to guide antiviral drug treatment is established in clinical practice. In response to the recent and future availability of DAA agents, some experts anticipate that drug resistance testing will provide similar value to the clinical management of HCV infection.
About LabCorp(R)
Laboratory Corporation of America(R) Holdings, an S&P 500 company, is a pioneer in commercializing new diagnostic technologies and the first in its industry to embrace genomic testing. With annual revenues of $5.0 billion in 2010, over 31,000 employees worldwide, and more than 220,000 clients, LabCorp offers a broad test menu ranging from routine blood analyses to reproductive genetics to DNA sequencing. LabCorp furthers its scientific expertise and innovative clinical testing technology with its Centers of Excellence: The Center for Molecular Biology and Pathology, National Genetics Institute, ViroMed Laboratories, Inc., The Center for Esoteric Testing, Litholink Corporation, Genzyme Genetics(SM)*, DIANON Systems, Inc., US LABS, Monogram Biosciences, Inc., and Esoterix and its Colorado Coagulation, Endocrine Sciences, and Cytometry Associates laboratories. LabCorp conducts clinical trials testing through its Esoterix Clinical Trials Services division. LabCorp clients include physicians, government agencies, managed care organizations, hospitals, clinical labs, and pharmaceutical companies. To learn more about our organization, visit our Web site at: www.labcorp.com .
*Genzyme Genetics and its logo are trademarks of Genzyme Corporation and used by Esoterix Genetic Laboratories, LLC, a wholly-owned subsidiary of LabCorp, under license. Esoterix Genetic Laboratories and LabCorp are operated independently from Genzyme Corporation.
This press release contains forward-looking statements. Each of the forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions in the marketplace and adverse actions of governmental and other third-party payors. Actual results could differ materially from those suggested by these forward-looking statements. Further information on potential factors that could affect LabCorp's financial results is included in the Company's Form 10-K for the year ended December 31, 2010, and subsequent SEC filings.
SOURCE: Laboratory Corporation of America(R) Holdings
Showing posts with label LabCorp. Show all posts
Showing posts with label LabCorp. Show all posts
Thursday, August 25, 2011
Friday, February 25, 2011
Scripps Health to offer genetic testing to HCV patients...
Sounds good on the surface, but I've heard mixed things about the IL28B genetic test... at least four providers I've talked to that have been using the IL28B test say that it really doesn't predict much at all and in fact, can create an environment of 'treatment nihilism' if the patient turns out to have the T/T allele. According to anecdotal evidence, these providers have had subjects with the T/T allele respond just as favorably as those with the C/C allele and had cases where the patient with the C/C allele haven't responded at all. The bottom line - a genetic test should act only as one predictor of outcomes along with many others, such as age, fibrosis status, kidney function, adherence and social support, etc. No one should be denied therapy as a result of the IL28B test.
Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C Patients
Date: 25 February 2011
Source: Scripps Health Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C PatientsIndividualized Therapies Now Available for Drug Treatment of Hepatitis C
SAN DIEGO, Feb. 25, 2011 (GLOBE NEWSWIRE) -- Scripps Health is one of the first health systems in the United States to offer genetic testing as part of its care for hepatitis C patients planning to undergo drug treatment.
The tests offer hope to the more than 4 million patients diagnosed annually in the U.S. with hepatitis C and could spare them from taking interferon, which is commonly prescribed. Interferon causes flu-like symptoms as a side effect and costs more than $50,000 annually. Instead, the genetic test determines whether patients have a common gene variant that predicts a favorable cure rate if they are treated with the drug combination therapy of pegylated interferon and ribavirin.
A manuscript describing this approach to treatment, authored by Paul J. Pockros, MD, clinical director of research at the Scripps Translational Science Institute, head of the Division of Gastroenterology and Hepatology and director of the Liver Disease Center at Scripps Clinic, will be published in the journal Drugs in March.
"This is a huge step forward in the movement toward individualized medicine," said Dr. Pockros, "As a physician, knowing what drug therapies will have benefit and which ones won't based on a patient's IL28B genotype is significant because we are able to be more targeted in our approach to treatment."
This is the first of numerous genetic tests that will accurately give doctors vastly improved data, leading to better prescription of drug treatments. Later this year, a second test will be available that will accurately predict anemia in hepatitis C patients taking the pegylated interferon and ribavirin drug combination. Anemia is one of the most common side effects of the regimen. This will allow doctors to modify the therapy before starting the regimen to prevent patients from developing this problematic side effect.
Genetic testing for hepatitis C patients carries significant implications for patient care, as there are more than 4 million infected people in the United States, most of them undiagnosed and untreated.
Scripps Clinic now routinely orders IL28B genotyping on all patients with Hepatitis C who are potential candidates for anti-viral therapy. If the patients have a favorable IL28B genotype and advanced fibrosis on liver biopsy, doctors can initiate therapy with the current standard of care. If patients have a less favorable genotype or they have mild fibrosis, doctors can recommend waiting for FDA approval of direct acting antiviral drugs to improve their chances of response.
Currently, LabCorps Diagnostics is performing the IL28B testing for Scripps patients, a procedure covered by most insurance plans. The results are transmitted to the treating physician in about one week and the treatment choice is tailored based on the patient's likelihood to have a favorable response.
The hepatitis C genetic testing is the latest example of Scripps' leadership in individualized medicine. Scripps doctors were the first to use genetic testing for cardiovascular patients planning to undergo elective stent procedures to determine if they have one or more of the common gene variants linked to an inability to metabolize the anti-clotting drug Plavix (clopidrogel). Plavix is the second-most commonly prescribed drug in the United States and is given to most patients after they receive coronary stents.
ABOUT SCRIPPS HEALTH
Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a $2.3 billion nonprofit community health system based in San Diego, Calif. Scripps treats a half-million patients annually through the dedication of 2,500 affiliated physicians and 13,000 employees among its five acute-care hospital campuses, home health care services, and an ambulatory care network of physician offices and 22 outpatient centers and clinics. Scripps has been recognized by Thomson Reuters as one of the Top 10 health systems in the nation for quality care. Scripps is also at the forefront of clinical research, genomic medicine, wireless health and graduate medical education. With three highly respected graduate medical education programs, Scripps is a longstanding member of the Association of American Medical Colleges. More information can be found at www.scripps.org.
This information was brought to you by Cision http://www.cisionwire.com
CONTACT: Johnny Hagerman 858-361-8962 hagerman.johnny@scrippshealth.org
Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C Patients
Date: 25 February 2011
Source: Scripps Health Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C PatientsIndividualized Therapies Now Available for Drug Treatment of Hepatitis C
SAN DIEGO, Feb. 25, 2011 (GLOBE NEWSWIRE) -- Scripps Health is one of the first health systems in the United States to offer genetic testing as part of its care for hepatitis C patients planning to undergo drug treatment.
The tests offer hope to the more than 4 million patients diagnosed annually in the U.S. with hepatitis C and could spare them from taking interferon, which is commonly prescribed. Interferon causes flu-like symptoms as a side effect and costs more than $50,000 annually. Instead, the genetic test determines whether patients have a common gene variant that predicts a favorable cure rate if they are treated with the drug combination therapy of pegylated interferon and ribavirin.
A manuscript describing this approach to treatment, authored by Paul J. Pockros, MD, clinical director of research at the Scripps Translational Science Institute, head of the Division of Gastroenterology and Hepatology and director of the Liver Disease Center at Scripps Clinic, will be published in the journal Drugs in March.
"This is a huge step forward in the movement toward individualized medicine," said Dr. Pockros, "As a physician, knowing what drug therapies will have benefit and which ones won't based on a patient's IL28B genotype is significant because we are able to be more targeted in our approach to treatment."
This is the first of numerous genetic tests that will accurately give doctors vastly improved data, leading to better prescription of drug treatments. Later this year, a second test will be available that will accurately predict anemia in hepatitis C patients taking the pegylated interferon and ribavirin drug combination. Anemia is one of the most common side effects of the regimen. This will allow doctors to modify the therapy before starting the regimen to prevent patients from developing this problematic side effect.
Genetic testing for hepatitis C patients carries significant implications for patient care, as there are more than 4 million infected people in the United States, most of them undiagnosed and untreated.
Scripps Clinic now routinely orders IL28B genotyping on all patients with Hepatitis C who are potential candidates for anti-viral therapy. If the patients have a favorable IL28B genotype and advanced fibrosis on liver biopsy, doctors can initiate therapy with the current standard of care. If patients have a less favorable genotype or they have mild fibrosis, doctors can recommend waiting for FDA approval of direct acting antiviral drugs to improve their chances of response.
Currently, LabCorps Diagnostics is performing the IL28B testing for Scripps patients, a procedure covered by most insurance plans. The results are transmitted to the treating physician in about one week and the treatment choice is tailored based on the patient's likelihood to have a favorable response.
The hepatitis C genetic testing is the latest example of Scripps' leadership in individualized medicine. Scripps doctors were the first to use genetic testing for cardiovascular patients planning to undergo elective stent procedures to determine if they have one or more of the common gene variants linked to an inability to metabolize the anti-clotting drug Plavix (clopidrogel). Plavix is the second-most commonly prescribed drug in the United States and is given to most patients after they receive coronary stents.
ABOUT SCRIPPS HEALTH
Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a $2.3 billion nonprofit community health system based in San Diego, Calif. Scripps treats a half-million patients annually through the dedication of 2,500 affiliated physicians and 13,000 employees among its five acute-care hospital campuses, home health care services, and an ambulatory care network of physician offices and 22 outpatient centers and clinics. Scripps has been recognized by Thomson Reuters as one of the Top 10 health systems in the nation for quality care. Scripps is also at the forefront of clinical research, genomic medicine, wireless health and graduate medical education. With three highly respected graduate medical education programs, Scripps is a longstanding member of the Association of American Medical Colleges. More information can be found at www.scripps.org.
This information was brought to you by Cision http://www.cisionwire.com
CONTACT: Johnny Hagerman 858-361-8962 hagerman.johnny@scrippshealth.org
Wednesday, September 15, 2010
LabCorp Enhances HCV Testing Services with the Launch of IL-28B Test
Assay is Commercially Available for Patient Testing and Clinical Trials BURLINGTON, N.C.--(BUSINESS WIRE [1])-- Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) announced today the nationwide availability of a genetic test to detect the presence of a single polymorphism within the IL-28B gene that has been reported to help predict a person’s response to certain hepatitis C virus (HCV) therapies.
“This test represents an important addition to the management and treatment of HCV infections, and complements the current company test portfolio for this disease,” indicated Dr. Mark Brecher, LabCorp’s Chief Medical Officer. “The ability to detect the polymorphism within the IL-28B gene may help predict the response to treatments, leading to an improvement in patient care and a reduction in treatment costs.”
An estimated 3.2 million people in the United States and 170 million people worldwide are infected with HCV. The recommended treatment regimen for chronic infection includes pegylated interferon-based therapies. However, some patients experience limited efficacy, treatment is often poorly tolerated and the side effects prevent some patients from completing therapy. Therefore, identifying patients who may be likely to have a favorable response to treatment is a high priority.
The importance of the IL-28B genetic polymorphism was first reported in the journal Nature (September 2009) by scientific teams from Merck and Duke University. Specific variants in this gene have been associated with an approximately 2-3 fold greater rate of sustained viral suppression in response to treatment with combination pegylated interferon alfa/ribavirin therapy among patients infected with HCV genotype 1 with a CC genotype as compared with either the CT or TT genotypes. HCV genotype 1 is the most common form of the virus, accounting for approximately 70 percent of HCV cases in the U.S.
The test is now available for patient testing through LabCorp’s Centers of Excellence, Monogram Biosciences and The Center for Molecular Biology and Pathology (CMBP). The test is also available through Esoterix Clinical Trials Services for clinical trials. LabCorp has licensed global rights to this marker from Merck.
“This test represents an important addition to the management and treatment of HCV infections, and complements the current company test portfolio for this disease,” indicated Dr. Mark Brecher, LabCorp’s Chief Medical Officer. “The ability to detect the polymorphism within the IL-28B gene may help predict the response to treatments, leading to an improvement in patient care and a reduction in treatment costs.”
An estimated 3.2 million people in the United States and 170 million people worldwide are infected with HCV. The recommended treatment regimen for chronic infection includes pegylated interferon-based therapies. However, some patients experience limited efficacy, treatment is often poorly tolerated and the side effects prevent some patients from completing therapy. Therefore, identifying patients who may be likely to have a favorable response to treatment is a high priority.
The importance of the IL-28B genetic polymorphism was first reported in the journal Nature (September 2009) by scientific teams from Merck and Duke University. Specific variants in this gene have been associated with an approximately 2-3 fold greater rate of sustained viral suppression in response to treatment with combination pegylated interferon alfa/ribavirin therapy among patients infected with HCV genotype 1 with a CC genotype as compared with either the CT or TT genotypes. HCV genotype 1 is the most common form of the virus, accounting for approximately 70 percent of HCV cases in the U.S.
The test is now available for patient testing through LabCorp’s Centers of Excellence, Monogram Biosciences and The Center for Molecular Biology and Pathology (CMBP). The test is also available through Esoterix Clinical Trials Services for clinical trials. LabCorp has licensed global rights to this marker from Merck.
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