Quest Diagnostics has launched their own IL28B test called AccuType to compete with LabCorp's IL28B assay. As discussed before, I've talked with several physicians who felt that the assay is helpful, but may not be clinically relevant enough to make the decision to treat or not to treat, despite the data to back the assay. They've had enough T/T's succeed in achieving SVR and enough C/C's fail therapy to know that the IL28B polymorphism is an important factor in achieving an SVR, but certainly not the only one. In the words of one physician, "RVR trumps all". I've also talked with several who buy into the importance of the assay in making treatment decisions. I reckon the market will decide for us.
AccuType® IL28B test now available to physicians and for clinical trials research
MADISON, N.J., April 18, 2011 /PRNewswire/ -- Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced the availability of its AccuType® IL28B test for aiding in the prediction of patient response to peginterferon alpha-based therapy for hepatitis C virus (HCV) infection. Quest Diagnostics is now offering the test to physicians and other healthcare providers in the U.S. and to pharmaceutical companies for use in clinical trials research.
The test was developed through a global non-exclusive license agreement under which Schering Corporation, a Merck affiliate, licensed certain patent rights claiming Interleukin (IL) 28B genetic markers to Quest Diagnostics. These genetic markers have been shown to provide an indicator of potential response to peginterferon alpha-based therapy for HCV. Additional terms were not disclosed.
"Our AccuType IL28B test will give physicians greater insights for treating individual patients infected with the most common form of HCV using standard antiviral therapies," said Rick L. Pesano, M.D., Ph.D., medical director, infectious diseases, Quest Diagnostics. "AccuType IL28B testing will also help physicians consider alternative therapies, which in the future may include HCV protease inhibitors."
Combination interferon-ribavirin therapy administered over several months is considered standard of care in treating HCV, although experimental HCV protease inhibitors are now under priority review by the U.S. Food and Drug Administration.(1),(2) Side effects, such as fatigue, depression and nausea, affect the majority of patients, and an estimated 10% to 14% of people discontinue therapy.(3),(4) Moreover, as many as one in two patients fail to eradicate the virus, as indicated by blood tests, after a full course of therapy.(5)
A certain polymorphism of the IL28B gene found in individuals infected with the most common type of HCV, HCV genotype 1, aids in identifying those patients who are twice as likely to eliminate the HCV virus on a sustained basis when treated with pegylated interferon-ribavirin combination therapies.(6) Other factors, including age and gender, may affect treatment response.
HCV infection is the most common chronic blood borne infection in the United States, chronically infecting approximately 3.2 million people. Left untreated, chronic HCV can lead to liver cancer or liver cirrhosis requiring liver transplantation. Chronic HCV infection accounts for an estimated 8,000 to 10,000 deaths each year in the United States.(7)
About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.
Quest Diagnostics' broad hepatitis C and B virus testing menu includes hepatic function tests to help determine HCV exposure and identify abnormal liver function; Heptimax® viral RNA quantitative testing to monitor viral load during therapy; and HCV genotyping to aid in predicting treatment duration and success. Quest Diagnostics also offers tests, such as HepaScore™, to help physicians identify and stage liver fibrosis.
Additional company information is available at www.QuestDiagnostics.com.
Quest, Quest Diagnostics, the associated logo, Nichols Institute and all associated Quest Diagnostics marks are the registered trademarks of Quest Diagnostics. All third party marks — ®' and ™' — are the property of their respective owners. © 2000-2011 Quest Diagnostics Incorporated. All rights reserved.
(1) Merck press release, 1/6/11; Vertex Pharmaceuticals press release; 1/20/11.
(2) HCSP Fact Sheet, Hepatitis C Support Project (HCSP);2008;ver 3.
(3) Lancet 2001; 358:958-965.
(4) N Engl J Med 2002; 347:975-982.
(5) HCSP Fact Sheet, Hepatitis C Support Project (HCSP),ver 3, 12/08.
(6) "Nature, 2009;10.1038;1-3.
(7) Hepatitis C FAQs for Health Professionals, U.S. Centers for Disease Control and Prevention Source, updated 12/17/10.
Quest Diagnostics Contacts:
Wendy Bost (Media): 973-520-2800
Kathleen Valentine (Investors): 973-520-2900
SOURCE Quest Diagnostics Incorporated
Back to top
RELATED LINKS
http://www.questdiagnostics.com
Showing posts with label IL28B. Show all posts
Showing posts with label IL28B. Show all posts
Tuesday, April 19, 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
Friday, June 4, 2010
Online article in the journal "Hepatology" looks at IL28B effect on Telaprevir response
Just published online from the journal Hepatology: A small Japanese study looks to see if amino acid substitution in the HCV core region in conjunction with genetic variation near the IL28B gene can predict viral response to a 12 or 24 week regimen of Telaprevir + P/R in a similar way to how it predicts response in good ol' fashioned peginterferon and ribavirin.
Investigators looked at 72 of 81 Japanese adults infected with HCV genotype 1b. Authors conclusion's cut n' pasted from the actual study below. Looks very positive, but needs a trial with larger numbers in different genotypes and ethnicities to really be sure.
Overall, sustained virological response and end-of-treatment response were achieved by 61% and 89%, respectively. Especially, sustained virological response was achieved by 45% and 67% in 12- and 24-week regimen, respectively. Multivariate analysis identified rs8099917 near IL28B gene (genotype TT) and substitution at aa 70 (Arg70) as significant determinants of sustained virological response. Prediction of response to therapy based on combination of these factors had high sensitivity, specificity, positive and negative predictive values. Efficacy of triple therapy was high in the patients with genotype TT who accomplished sustained virological response (84%), irrespective of substitution of core aa 70. In the patients having genotype non-TT, those of Arg70 gained high sustained virological response (50%), and sustained virological response (12%) were the worst in patients who possessed both of genotype non-TT and Gln70(His70). In conclusions, this study identified genetic variation near IL28B gene and aa substitution of the core region as predictors of sustained virological response to triple therapy of telaprevir/PEG-IFN/ribavirin in Japanese patients infected with HCV genotype 1b.
Investigators looked at 72 of 81 Japanese adults infected with HCV genotype 1b. Authors conclusion's cut n' pasted from the actual study below. Looks very positive, but needs a trial with larger numbers in different genotypes and ethnicities to really be sure.
Overall, sustained virological response and end-of-treatment response were achieved by 61% and 89%, respectively. Especially, sustained virological response was achieved by 45% and 67% in 12- and 24-week regimen, respectively. Multivariate analysis identified rs8099917 near IL28B gene (genotype TT) and substitution at aa 70 (Arg70) as significant determinants of sustained virological response. Prediction of response to therapy based on combination of these factors had high sensitivity, specificity, positive and negative predictive values. Efficacy of triple therapy was high in the patients with genotype TT who accomplished sustained virological response (84%), irrespective of substitution of core aa 70. In the patients having genotype non-TT, those of Arg70 gained high sustained virological response (50%), and sustained virological response (12%) were the worst in patients who possessed both of genotype non-TT and Gln70(His70). In conclusions, this study identified genetic variation near IL28B gene and aa substitution of the core region as predictors of sustained virological response to triple therapy of telaprevir/PEG-IFN/ribavirin in Japanese patients infected with HCV genotype 1b.
Subscribe to:
Posts (Atom)
Posts
