News Article | November 14, 2016
BRIDGEWATER, N.J., Nov. 14, 2016 (GLOBE NEWSWIRE) -- Clinical Genomics, a private company developing evidence-driven diagnostic tools for colorectal cancer, today announced the appointment of Michael Dugan, M.D. as Chief Medical Officer. Dr. Dugan’s addition to the leadership team will strengthen the Company as it prepares to make Colvera™, a blood-based test for colorectal cancer (CRC) recurrence monitoring, available later this year. “We are excited to welcome Dr. Dugan as CMO. His appointment comes at an important time as we approach the launch of Colvera,” said Lawrence LaPointe, Ph.D., President and CEO of Clinical Genomics. “Dr. Dugan’s extensive experience in developing and launching novel diagnostic tests make him uniquely suited to help us realize our near and long term goals. We are confident that his demonstrated track record across the entire product development continuum will bring value to our team.” Dr. Dugan brings more than 20 years of executive-level experience in healthcare management, clinical development, market evaluation and laboratory operations to Clinical Genomics. Previously, he served as President and CEO of MCDXI Medical Diagnostics, where he led clinical evaluation, strategic development and clinical education efforts for several companies introducing novel diagnostic tests, platforms and related products to market. Dr. Dugan’s previous roles include Senior Vice President of Clinical Development and Medical Affairs at Exact Sciences, Medical Director at Quest Diagnostics Nichols Institute and Vice President and Laboratory Director at Specialty Laboratories, Inc. He holds a B.S. in Biology from the University of Notre Dame, an M.D. from the University of Arizona College of Medicine, and completed postgraduate training in pathology and laboratory medicine at Yale University and UCLA. About Colorectal Cancer (CRC) Colorectal Cancer (CRC) is one of the leading causes of cancer-related deaths worldwide, accounting for more than 600,000 deaths each year. When diagnosed early, before cancer has spread, the relative five-year survival rate for CRC is 90 percent, but only approximately four out of 10 CRC cases are detected early. Among individuals undergoing surgical treatment for CRC, recurrence occurs in 30 to 40 percent of all cases, the majority of which present in the first two to three years following initial diagnosis and treatment. About Clinical Genomics Clinical Genomics is a privately held biotechnology company committed to reducing the impact of colorectal cancer (CRC) through early detection of disease and clinically actionable, evidence-driven recurrence monitoring tools. With a broad intellectual property portfolio consisting of more than 20 patents, Clinical Genomics, via its wholly-owned subsidiary Enterix Inc., currently offers the user-friendly, patient-preferred CRC screening InSure® FIT™ assay, a fecal immunochemical test that detects blood in the stool. InSure is also marketed as a lab-based test in Australia and other countries (ColoVantage Home). Building on an established history in the field of CRC screening and diagnosis, Clinical Genomics developed a sensitive and specific blood-based circulating tumor DNA (ctDNA) test for colorectal cancer based on methylated DNA from two genes, BCAT1 and IKZF1. The Company plans to offer this two-gene test for recurrence monitoring later in 2016. Clinical Genomics has offices and laboratories in Bridgewater and Edison, New Jersey and Sydney, Australia, and operates as an FDA-registered and TGA-licensed manufacturer and a NATA-accredited laboratory. For more information, please visit www.clinicalgenomics.com.
News Article | November 15, 2016
Executive recruitment firm Slone Partners is proud to announce the placement of Dr. Michael Dugan, an esteemed biotechnology leader with extensive clinical experience in both commercial and academic settings, as Chief Medical Officer of Clinical Genomics. Clinical Genomics is a leading biotechnology company that develops innovative products for colorectal cancer diagnosis. With a broad intellectual property portfolio including more than 20 patents, Clinical Genomics delivers products to improve early cancer detection. In his new role, Dr. Dugan will lead medical affairs and clinical trials, develop key opinion leader relationships, and build a Scientific Advisory Board. In addition, he will serve as a member of the executive team responsible for establishing business and payer strategies. “Dr. Dugan’s unique background will further strengthen the leadership team we have in place. He brings years of clinical, commercial and management experience that will contribute to the sustained growth of Clinical Genomics and to the development of clinically actionable, evidence-driven colorectal cancer recurrence monitoring tools,” stated Dr. Lawrence LaPointe, President & CEO of Clinical Genomics. “Our ongoing strategic collaboration with Slone Partners was instrumental in securing Dr. Dugan’s placement and we look forward to a long-term continuing partnership.” With over 20 years of experience, Dr. Dugan is an acclaimed healthcare leader and clinical operations expert. Prior to joining Clinical Genomics, he served as President & CEO of MCDXI Medical Diagnostics International where he worked with advanced biotechnology companies in oncology and other clinically related applications to bring novel diagnostic tests to market. Before that, Dr. Dugan was the Senior Vice President of Clinical Development and Medical Affairs at Exact Sciences Corporation. He also served as Medical Director at Quest Diagnostics Nichols Institute, Chief Medical Officer at bioTheranostics, VP & Chief Medical Officer at Roche Molecular Systems, Inc., and VP of Pathology Services at Genzyme Genetics. Dr. Dugan received a Bachelor of Science in Biology from the University of Notre-Dame and a Medical Degree from the University of Arizona College of Medicine. Founded in 2000, Slone Partners is a premier executive search firm that specializes in recruitment for the diagnostics, life sciences, clinical trials, contract research, healthcare information technology and laboratory testing industries with offices in Boston, Washington, D.C. and San Francisco. For more information on Slone Partners, visit http://www.slonepartners.com. Clinical Genomics is a privately held biotechnology company developing innovative products for colorectal cancer (CRC) diagnosis. With a broad intellectual property portfolio consisting of more than 20 patents, Clinical Genomics, via its wholly-owned subsidiary Enterix Inc., currently offers the user-friendly, patient-preferred colorectal cancer screening InSure® FIT™ assay, a fecal immunochemical test that detects blood in the stool. InSure is also marketed as a lab-based test in Australia and other countries (ColoVantage Home). Building on an established history in the field of CRC screening and diagnosis, Clinical Genomics developed a sensitive and specific blood-based circulating tumor DNA (ctDNA) test for colorectal cancer based on methylated DNA from two genes, BCAT1 and IKZF1. The Company plans to make its two-gene test for recurrence monitoring available prior to the end of 2016. Clinical Genomics has offices and laboratories in Bridgewater and Edison, New Jersey and Sydney, Australia, and operates as a FDA-registered and TGA-licensed manufacturer and a NATA-accredited laboratory. For more information, please visit http://www.clinicalgenomics.com.
Nguyen H.M.,Northwest Permanente |
Shier K.L.,Quest Diagnostics Nichols Institute |
Graber C.J.,University of California at Los Angeles
Journal of Antimicrobial Chemotherapy | Year: 2014
Traditionally, physicians have not used cefepime (a fourth-generation cephalosporin with greater stability against β-lactamases) or β-lactam/β-lactamase inhibitors (BLBLIs) for infections caused by bacteria (generally Escherichia coli and Klebsiella species) that produce an extended-spectrum β-lactamase (ESBL). Many microbiology laboratories have historically labelled these ESBL-producing organisms as resistant to all cephalosporins regardless of their MIC. The recommendation to eliminate ESBL identification started with EUCAST in 2009, followed by CLSI in 2010. As a consequence, many ESBL-producing organisms that were previously labelled as resistant to all cephalosporins may be reclassified as susceptible to some (particularly cefepime), depending on their MICs. Because there are limited treatment options against ESBL-producing organisms, there is growing interest in using cefepime and BLBLIs. In this review, we examine the clinical outcomes of therapy directed against ESBL-producing Enterobacteriaceae and the pharmacokinetics/pharmacodynamics of cefepime and BLBLIs to construct a clinical framework for how physicians can best employ these carbapenem-sparing alternatives for the treatment of infections caused by ESBL-producing Enterobacteriaceae. We conclude that standard-dose cefepime is a reasonable option for the definitive therapy of invasive infections resulting from ESBL-producing E. coli and Klebsiella species when the MIC for the organism is ≤2 mg/L (CLSI) or ≤1 mg/L (EUCAST), although higher doses may be considered for MICs in the 4-8 mg/L range. Piperacillin/tazobactam is also a reasonable option when the MIC is ≤16 mg/L. © The Author 2013. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.
Pesano R.L.,Quest Diagnostics Nichols Institute
Antiviral Therapy | Year: 2012
Recent advances in diagnosis and treatment are providing physicians with new options for managing patients with chronic HCV infection. The potential of these new technologies, however, can only be fully realized in the US if surveillance of new cases is improved; this can be achieved by establishing and implementing comprehensive test reporting requirements and by ensuring that physicians have a good understanding of appropriate test ordering and interpretation. Harmonized reporting standards, combined with physician education, will lead to improved identification of infected individuals and increased timeliness of medical interventions. ©2012 International Medical Press.
Stanczyk F.Z.,University of Southern California |
Clarke N.J.,Quest Diagnostics Nichols Institute
Journal of Steroid Biochemistry and Molecular Biology | Year: 2010
Although steroid hormones have been measured, primarily in urine, by gas chromatography-mass spectrometry (GC-MS) assays for many years, in the past decade both clinical and research laboratories have dramatically increased usage of liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays for measuring circulating levels of steroid hormones. Because of their high validity and throughput, mass spectrometry (MS) assays have replaced conventional radioimmunoassays (RIAs) and direct immunoassays for steroid hormones in larger reference laboratories, and they are touted to become the " gold standard" for steroid hormone quantitation. These advances in MS assays present several major challenges, which include the affordability of smaller laboratories to purchase MS instruments and pay for related operating costs; improving assay sensitivity, especially for measuring low estradiol levels in postmenopausal women and women treated with aromatase inhibitors; developing assays for quantitating profiles of steroid hormone metabolites in serum and tissues; standardizing steroid MS assays; and obtaining reliable reference intervals. The present review discusses the advantages of MS assays over conventional RIAs and direct immunoassays in steroid hormone measurements, and points out some of the important challenges facing the rapid increase in usage of MS assays. © 2010.
Nakamoto J.M.,Quest Diagnostics Nichols Institute
Obstetrics and Gynecology | Year: 2011
Objective: To estimate the screening rate and prevalence of gestational diabetes mellitus (GDM) and the screening rate and prevalence of postpartum diabetes, in a large, national sample of pregnant women. We also estimated the potential effects of the new International Association of Diabetes and Pregnancy Study Groups recommendations, which replace the 100-g oral glucose tolerance test (OGTT) with the 75-g OGTT, on GDM prevalence and gestational plasma glucose testing practices. Methods: We identified pregnant women who used the laboratory services of Quest Diagnostics and who were screened for GDM and were tested postpartum. Gestational diabetes mellitus prevalence was calculated according to the current American Diabetes Association/ Carpenter-Coustan criteria, and the new International Association of Diabetes and Pregnancy Study Groups criteria. Results: Sixty-eight percent (632,820/924,873) of pregnant women aged 25 to 40 (ie, those not in a low-risk age group) who utilized the services of Quest Diagnostics during this study were screened for GDM. Of the entire adult pregnant population (ages 18-40) who received GDM screening, 5% (40,955/842,993) had positive test results under the current criteria. Nineteen percent (4,486/23,299) of those with GDM received postpartum diabetes testing within a 6-month period. Ninety percent (148,749/166,085) of all confirmatory GDM tests performed on pregnant women at Quest Diagnostics were the 100-g OGTT. The number of women with GDM after receiving the 75-g OGTT would have doubled under the International Association of Diabetes and Pregnancy Study Groups criteria. Conclusion: Many women may not be receiving GDM screening during pregnancy. Postpartum diabetes screening rates after pregnancy remain low. Adoption of the new International Association of Diabetes and Pregnancy Study Groups criteria would require a significant change in current clinical practice. © 2010 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins.
Strom C.M.,Quest Diagnostics Nichols Institute
Clinics in Laboratory Medicine | Year: 2012
This article reflects on my nearly 40 years providing clinical and laboratory genetic services. It reviews the evolution of laboratory and genetic testing from their grant-supported academic research to current complexities. Changes in the economic and academic landscape parallel technological innovations in laboratory testing. My career trajectory parallels the newer trend of genetic testing. I began in academics, working as a student and postdoctoral fellow in academic laboratories that also provided clinical testing services. Next came time in a small molecular laboratory performing diagnosis and testing services. My current position is with a national commercial laboratory company. © 2012 Elsevier Inc.
Blatt A.J.,Quest Diagnostics |
Nakamoto J.M.,Quest Diagnostics Nichols Institute |
Kaufman H.W.,Quest Diagnostics
Journal of Clinical Endocrinology and Metabolism | Year: 2012
Context: Hypothyroidism, overt or subclinical, is associated with adverse outcomes for pregnant women and their offspring. Knowledge of current national thyroid testing rates and positivity during pregnancy is limited. Objective:Theaimof the studywasto estimate thyroid testing rateandpositivity during pregnancy and postpartum, including testing and positivity rates of thyroperoxidase antibody (TPO Ab) and free T 4 tests in pregnant women with elevated TSH levels (hypothyroid), and in pregnant women having TSH within range (euthyroid). Design and Setting: Records from a large, national sample of pregnantwomenscreened from June 2005 through May 2008 were examined. Participants: The study included 502,036 pregnant women, for whom gestational age information was available. Main Measures: Testing rates and the prevalence of hypothyroidism during pregnancy and postpartum were measured using assay-specific, trimester-specific reference intervals. Screening and positivity rates of TPO Ab and free T 4 tests were also measured. Results: Of women ages 18 to 40 yr, 23% (117,892 of 502,036) were tested for gestational hypothyroidism (defined as both subclinical and overt hypothyroidism). Of these, 15.5% (18,291 of 117,892) tested positive for gestational hypothyroidism. Twenty-four percent (22,650 of 93,312) of women with TSH within range and 33% (6,072 of 18,291) of women with elevated TSH were also tested for gestational hypothyroxinemia. Gestational hypothyroxinemia was seen in 0.2% (47 of 22,650) of the tested women with TSH within range and was seen in 2.4% (144 of 6,072) of the tested women having elevated TSH; 0.3% (276 of 93,312) of women with TSH within range received a TPO Ab test, and of these, 15% (41 of 276) tested positive; 0.66% (120 of 18,291) of women with elevated TSH received a TPOAb test, and of these, 65%(78 of 120) tested positive. Only 20.7%(1873 of 9063) of hypothyroid women received thyroid screening within 6 months postpartum; of these, 11.5% (215 of 1873) were diagnosed with postpartum hypothyroidism. Conclusion: Gestational hypothyroidism is more common than generally acknowledged. Testing is not common, and test selection is variable. There is a low rate of postpartum follow-up. Copyright © 2012 by The Endocrine Society.
Clarke N.J.,Quest Diagnostics Nichols Institute
Clinical Chemistry | Year: 2016
BACKGROUND: Precision medicine is becoming a major topic within the medical community and is gaining traction as a standard approach in many disciplines. This approach typically revolves around the use of a patient's genetic makeup to allow the physician to choose the appropriate course of treatment. In many cases the genetic information directs the drug to be used to treat the patient. In other cases the genetic markers associated with enzyme function may inform dosage recommendations. However there is a second way in which precision medicine can be practiced-that is, by therapeutic drug monitoring (TDM). CONTENT: A review of the use of mass spectrometry for TDM in the arena of precision medicine is undertaken. Because the measurement of a drug or its metabolites provides the physician with a snapshot of the therapeutic exposure the patient is undergoing, these concentrations can be thought of as an actual phenotype measurement based around the patient's genetics coupled with all of the environmental, pharmacological, and nutritional variables. The outcome of a TDM measurement by mass spectrometry provides the patient's current phenotype vs the potential phenotype imputed by the genetics. SUMMARY: The use of mass spectrometry can provide an understanding of how a drug is interacting with the patient, and is orthoganol to the information provided by pharmacogenomic assays. Further, the speed and relatively low expense of drug monitoring by mass spectrometry makes it an ideal test for precision medicine patient management. © 2015 American Association for Clinical Chemistry.
Sanders H.R.,Quest Diagnostics Nichols Institute
Cancer genetics and cytogenetics | Year: 2010
Lung cancer is the leading cause of cancer-related deaths, with non-small-cell lung cancer (NSCLC) accounting for approximately 85% of cases. A significant proportion of NSCLC cases are not diagnosed until a late stage, when aggressive treatments are required but often prolong survival only modestly. Recent advances in molecular characterization of NSCLC have enabled identification of numerous cell growth and proliferation pathways that are disrupted in these tumors. This knowledge has provided insight into the mechanisms of tumor development in various histologic subtypes of NSCLC and has pointed the way toward targeted treatment strategies. In this review, we highlight literature findings of somatic mutations in genes involved in cell growth and proliferation that are commonly found in the various subtypes of NSCLC, and we discuss how these findings may relate to treatment strategies. Copyright © 2010 Elsevier Inc. All rights reserved.