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December 15, 2011

In This Issue:

arrowASH conference features a wide range of intriguing studies

arrowCleveland Clinic opens new home for Pathology and Laboratory Medicine

arrowTherakos to begin Phase Two study for treatment of graft-versus-host disease

arrowACIP recommends that boys and young men get HPV vaccine

arrowGenome Sequencing Reveals Genetic Changes in Triple Negative Breast Tumors

arrowCLSI publishes new guideline on assessment of fetal lung maturity by the lamellar body count

arrowThermo Fisher QC product cleared by FDA

arrowHot Clips: Regulations/Compliance

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ASH conference features a wide range of intriguing studies

The 53rd Annual Meeting of the American Society of Hematology, which convened in San Diego December 10 through 13, featured a wide range of important presentations and poster sessions. Among many highlights: Clark Distelhorst, MD, from Seidman Cancer Center at University Hospitals (UH) Case Medical Center and Case Western Reserve University School of Medicine, presented a session on autophagy and metabolism in lymphoid malignancies; James N. Kochenderfer, MD, Experimental Transplantation and Immunology Branch, National Cancer Institute in Bethesda, MD, discussed the B-cell antigen CD19 and its role in chemotherapy-resistant B-cell malignancies; Tatyana Feldman, MD, a hematologist and oncologist who specializes in lymphoma at John Theurer Cancer Center at Hackensack University Medical Center in Hackensack, NJ, discussed the difficulty of treating rare forms of lymphoma, as not many good therapies exist for treating the relatively small population of affected patients; Claudio Anasetti, MD, chair of the department of Blood and Marrow Transplant at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, presented findings that indicate that peripheral blood stem cell (PBSC) transplants increase the incidence of graft-versus-host disease (GVHD) ; and Sylvie Castaigne, MD, professor, Department of Hematology at Hôpital de Versailles, Versailles, France, reported that minimal dosing strategy with gemtuzumab ozogamicin improves survival in older patients with acute myeloid leukemia. View a comprehensive list of abstracts and presentations at the ASH website.

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Cleveland Clinic opens new home for Pathology and Laboratory Medicine

Cleveland Clinic recently completed construction of a $75 million building to house the hospital’s Pathology and Laboratory Medicine Institute and Cleveland Clinic Laboratories The ambitious project will improve medical testing capabilities, time, and efficiency of testing while creating new jobs. The new structure near the intersection of East 105th Street and Carnegie Avenue in Cleveland, Ohio, stands three stories high and covers 135,000 square feet. Cleveland Clinic was ranked one of the top hospitals in America by U.S. News & World Report in 2010, and this impressive structure will only enhance its reputation.

Currently, the Pathology and Laboratory Medicine Institute (PLMI) employs 1,300 people and conducts more than 12 million tests each year. Laboratory tests are a vital element of diagnosis, treatment planning and monitoring for every disease from the most common to the esoteric. Approximately 70 percent of all medical decisions are based on laboratory testing. Physicians rely on the specialists in the Institute to provide the expert diagnosis, second opinions, and subspecialty consultation that are the basis for effective patient care. Visit Cleveland Clinic’s site to learn more about how this distinguished medical institution is serving the public and supporting healthcare professionals.

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Therakos to begin Phase Two study for treatment of graft-versus-host disease

Therakos, Inc, has announced that the first patient has been enrolled in its Phase IIb clinical study evaluating the use of the company’s photopheresis technology in the treatment of patients with moderate-to-severe chronic Graft-versus-Host Disease (GvHD). An estimated 15,000 new patients worldwide are diagnosed every year with chronic GvHD, a life threatening condition occurring when a donor’s transplanted stem cells attack the recipient’s body.

The Therakos study will assess the safety and efficacy of extracorporeal photophoresis (ECP) treatment as an add-on to the standard of care for patients suffering from moderate-to-severe GvHD. ECP is a procedure performed outside the body using either the THERAKOS UVAR XTS Photopheresis System or the THERAKOS CELLEX Photopheresis System to withdraw a volume of whole blood that is then centrifuged to separate the white blood cells from the red blood cells and plasma. The red blood cells and plasma are immediately returned to the patient. The white blood cells are treated with methoxsalen, which is photoactivated after exposure to UVA light. The treated white blood cells are then reinfused into the patient. Patients will be enrolled over an 18-month period. Randomization will occur in a 1:1 ratio with half of the patients receiving the current standard of care and the other half receiving standard of care coupled with ECP.

The clinical study will consist of patients from across the United States and Europe. There will be roughly 35 sites participating in the trial. Full results of the study, expected in early 2013, will form the basis for a global Phase Three study. See a video in which top hospital administrators discuss ECP.

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ACIP recommends that boys and young men get HPV vaccine

The Advisory Commission on Immunization Practices (ACIP) has voted that the human papillomavirus (HPV) vaccine should be routinely offered to boys and young men ages 11 to 21. The government panel also voted to recommend the vaccine for men ages 22 to 26 who have sex with other men or who are immunocompromised. If widely adopted, the recommendations would represent a major extension of the use of the vaccine, which had previously, and somewhat controversially, been recommended only for girls and young women up to age 26. The panel recommends either of two vaccines, Merck’s Gardasil and GlaxoSmithKline’s Cervarix to girls and women; it specifies Gardasil for boys and men.

HPV has been linked to cervical cancer in women; genital warts, anal cancer, and oral cancer in both sexes; and penile cancer in men. It is believed to cause cancer only rarely, but the psychological stigma of testing positive for HPV is also invoked by supporters of widespread vaccination. Opponents often point to the costs: The Centers for Disease Control and Prevention estimates that if two-thirds of boys and young men between 11 and 21 complete the vaccination series, the cost will be about $850 million. MSNBC has an interesting report on the scientific and sociopolitical aspects of this development.

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Genome Sequencing Reveals Genetic Changes in Triple Negative Breast Tumors

Dramatic results of groundbreaking research were announced last week at the CRTC-AACR Breast Cancer Symposium in San Antonio. Initial data from an ongoing clinical trial, the first such trial designed to examine the utility of whole-genome sequencing for triple negative breast cancer, indicate activation of targets not previously associated with triple negative disease. The discovery could point toward new treatment strategies. Based on mutations uncovered by sequencing, physicians recommended the women enter treatment protocols for either existing drugs or new agents being evaluated in pharma-sponsored clinical trials.

Triple negative breast tumors, which make up nearly 20 percent of breast cancers, do not respond to treatment with targeted therapies such as Herceptin (trastuzumab). Of eleven such tumors sequenced to date, each was genomically unique, but common factors were seen. Some patients displayed amplified genes in the RAS pathway; one patient had amplification of the BRAF oncogene, as well as activation of a growth pathway known as the MEK/AKT pathway. That patient displayed an impressive response to a MEK/AKT inhibitor currently in a phase I clinical study.

Joyce O’Shaughnessy, MD, presented the data and stressed its far-reaching implications. "Those results are quite striking considering that these are women with advanced disease. If MEK/AKT activation is found to be present in a substantial fraction of triple negative patients, inhibitors of this pathway could prove a significant tool in fighting this disease. Learn more about the CRTC-AACR and developments at its recent meeting.

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CLSI publishes new guideline on assessment of fetal lung maturity by the lamellar body count

The Clinical and Laboratory Standards Institute (CLSI) recently published Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline (C58-A). This document provides guidelines for the use of automated cell counting to enumerate lamellar bodies in amniotic fluid. It describes the different counting technologies used in automated cell counters as well as methods laboratorians can use to verify/validate the lamellar body count (LBC) test.

Explains David G. Grenache, PhD, DABCC, FACB, Associate Professor of Pathology, University of Utah, and Medical Director, Special Chemistry, ARUP Laboratories. "The LBC test is performed using an automated cell counter to enumerate the number of lamellar bodies in amniotic fluid, and has been demonstrated to be as clinically useful as the surfactant/albumin ratio in predicting lung maturity. Because it is a 'laboratory-developed test,' laboratorians who wish to validate and implement LBC need to be aware of the many preanalytical, analytical, and utilization issues that are associated with it. C58 addresses these issues."

Lamellar body counting has proven to have many advantages over other tests of FLM, including rapid turnaround time, low reagent cost, and excellent clinical performance. As such, laboratory directors, medical technologists, laboratory supervisors, and pathologists, as well as in vitro diagnostic manufacturers involved in the development of devices and materials related to LBC testing, will benefit from using this guideline. Preview sample pages of C58-A at the CLSI site.

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Thermo Fisher QC product cleared by FDA

The FDA has given formal clearance to Thermo Fisher Scientific Inc.’s MAS Omni•CORE quality control product. The stamp of approval follows the recent release of the MAS Omni•IMMUNE and Omni•IMMUNE PRO quality control products. The MAS Omni•CORE is the third in a series of QC products that are designed for use with the latest generation of clinical laboratory instrumentation, where multiple technologies exist within a single platform.

The three products fundamentally shift the quality-control paradigm, consolidating several QC products that have historically been stand-alone. Omni•IMMUNE (including PRO) integrates routine immunoassay, tumor markers, and speciality immunoassay. Omni•CORE, which contains 89 claimed analytes, consolidates control materials for general chemistry, serum protein, TDM/toxicology, and immunology into a single QC product. All the MAS Omni quality control products are offered in three distinct levels, providing the flexibility to choose different levels based on lab testing needs to reduce cost and streamline workflow. Value assignment is provided for key integrated instrument systems. In addition, the MAS OMNI product line lets clinicians consolidate up to three separate QC products into one, while maintaining stability and performance claims. QC results can also be submitted into Thermo Scientific’s web-based quality assurance program, LabLink xL, for daily comparison, including peer based assessment. Find out more about Thermo Scientific MAS Omni quality controls.

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HOT CLIPS: Regulations/Compliance - Top Picks

Click on the highlighted links below to discover the top MLO archival properties concerning regulations/compliance, a topic that is now at the forefront of healthcare discussions.

  1. HIV testing update
  2. The lab’s increasing arsenal of tools to battle antibiotic resistance
  3. The continued rise of respiratory viruses
  4. HPV: A look into new methods for high-risk testing

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