July 1, 2009--ViraCor Laboratories and IBT Laboratories announce that the companies are merging to create a new specialty diagnostics laboratory. Uniting the strengths of ViraCor and IBT, the new company has a strong research and development (R&D) infrastructure and broad scientific proficiency that will allow it to create an expanded menu of diagnostic tests to serve the unmet needs of physicians, hospitals and researchers in the immunology and infectious disease arenas nationwide. The company also will offer an extensive range of services to biopharmaceutical clients seeking support for discovery and clinical trial testing.

"ViraCor and IBT share many values and areas of expertise, and we have admired one another from afar for many years," says John Martin, president of ViraCor, who will serve as president of the combined company.  "Separately, our companies have become market leaders in niche areas and enjoyed significant growth over the last few years. Together, we have tremendous opportunity to grow and innovate. This merger gives ViraCor and IBT the combined scientific know-how and national network not only to reach additional customers who could benefit from our current test menu, but also to expand our services, providing the critical diagnostic information that clinicians need to improve health outcomes for patients."

The merger of ViraCor and IBT creates a combined company with more than 200 employees that serves more than 4,000 physicians, hospitals, commercial laboratories and biopharmaceutical companies. The new company's broad test menu includes cellular, immunology and allergy testing services as well as molecular assays that detect and monitor microbial pathogens.

"This is an important day for our companies, our clients, our communities and our industry," says Maureen Loftus, president of IBT, who will serve as chief business officer of the combined company. "ViraCor and IBT share a dedication to unsurpassed client service as well to pioneering science that addresses the unmet diagnostic needs of countless patients. By combining our expertise and resources, we have created a company with an unmatched commitment to patient care, a rich diagnostic test menu, and deep R&D capabilities that will continue to set new standards for quality service and science in the clinical laboratory industry." 

Established in 2000, ViraCor is a clinical reference and research laboratory with particular expertise in molecular infectious disease testing and in understanding the special needs of patients with compromised immune systems. These patients include those who have had organ transplants as well as cancer patients, individuals with autoimmune disorders and pre-term infants who have weaker immune systems. In addition to serving hospitals and physicians, ViraCor works with pharmaceutical companies and clinical researchers to conduct clinical trials.

IBT was founded in 1983 and is an allergy and immunology laboratory. It offers esoteric molecular and cellular immunology services for pharmaceutical clinical trials and patient care diagnostic testing. IBT's extensive experience and leading-edge research enable it to offer clients the most advanced immunodiagnostic services available in areas such as immune deficiency, autoimmune disease, skin allergy, drug immunogenicity and immunogenomics.  

The combined company will operate out of its two current laboratory facilities located 22 miles apart in Lee's Summit, MO and Lenexa, KS. ViraCor founder and CEO Phillip "Flip" Short will step down from his role as CEO and serve on the company's board of directors. IBT founder Dr. John Halsey will continue to work with the combined company as a consultant to ensure a successful transition. Dr. Laurence R. McCarthy, a venture partner at Ampersand Ventures who served as executive chairman of IBT's board of directors, will serve as executive chairman of the combined company's board of directors.

www.viracor.com

www.ibtlabs.com

June 30, 2009--Appendicitis has been notoriously difficult to diagnose, but a new urine test shows promise in improving diagnosis and reducing both unnecessary surgeries and appendix ruptures. The results of the study are reported online in the "Discovery and Validation of Urine Markers of Acute Pediatric Appendicitis Using High Accuracy Mass Spectrometry" in the Annals of Emergency Medicine.

"We found a biomarker in the urine of appendicitis patients (leucine-rich alpha 2 glycoprotein, or LRG), even in two patients whose imaging studies looked normal," says lead study author Richard Bachur, MD, of Children's Hospital in Boston. "This could be a big step forward in the practice of pediatric emergency medicine, especially because urine is so easy to obtain. For a frightened and uncomfortable child, a simple test that either spares them surgery they don't need or gets them into surgery before the appendix has ruptured could make a bad experience a little better."

In collaboration with the Proteomics Center at Children's Hospital Boston, researchers studied urine from 67 patients with a median age of 11, 37 percent of whom had appendicitis. All of the patients diagnosed with appendicitis underwent appendectomies; 16 percent of the removed appendixes had perforated. Once an appendix has perforated or ruptured, complications can ensue such as infection requiring lengthy hospitalization. Leucine-rich alpha-2-glycoprotein (or LRG) appears to be a specific marker for appendicitis.

Currently, three to 30 percent of appendectomies are found to be unnecessary, while 30 to 45 percent of appendicitis cases take so long to diagnose that the appendix ruptures. 

"Currently, the mass spectrometry needed to analyze urine for LRG is limited to large academic centers," says Dr. Bachur.  "However, clinical laboratory urine tests could be developed for rapid point-of-care testing.  This could be a significant breakthrough in diagnosing and treating a common pediatric emergency."

www.acep.org

June 23, 2009--Fluke Biomedical announces the launch of a new and improved Web site.  With updated functionality and a new look and feel, Fluke Biomedical's site now features enhanced search capabilities, a progressive user interface and a pleasant and efficient customer experience. It serves as another example of how Fluke Biomedical remains poised as the long-term solution for their customers. 

"Just like everything we do, this Web site is the culmination of extensive voice-of-the-customer research," says Roderick Jones, president of Fluke Biomedical. "And thanks to the advances we've made in our online customer support platform, what you see today is just the beginning of interesting things to come."

www.flukebiomedical.com

June 23, 2009--HHS Secretary Kathleen Sebelius announces that the department will pursue advanced development of new way to make influenza vaccine. The work will be done by Protein Sciences Corporation Inc. under a new $35 million contract. The contract could be extended up to five years at a total cost of approximately $147 million.

"The technology has advanced in recent years to a point that we believe it could help meet a surge in demand for U.S.-based vaccine for seasonal and pandemic flu," Secretary Sebelius says. "We want to use the technology to help our nation respond to emerging infectious diseases."

With this new technology, known as recombinant influenza vaccine, a gene would be extracted from a flu virus and placed into an insect virus called baculovirus, which does not affect people and can multiply quickly to high levels in insect cells. The cells are purified to become a basic part of a human vaccine.

Using this method, vaccine candidates, clinical investigational lots and commercial-scale vaccine production may be available faster than by using traditional vaccine production methods. Because the basic cells can be frozen and stored indefinitely, manufacturing large quantities of a vaccine is also faster using this recombinant technology.

The new contract will be administered by the Office of Biomedical Advanced Research and Development Authority (BARDA) within HHS and will support Protein Sciences Corporation Inc. in advanced development activities needed for potential Food and Drug Administration (FDA) approval to use this new technology for producing flu vaccines.

If this new technology is demonstrated to be safe and effective and the FDA licenses the new technology for flu vaccines, the contract requires the company to establish domestic manufacturing capability to provide a finished vaccine within 12 weeks of pandemic onset and to produce at least 50 million doses of pandemic flu vaccine within six months of pandemic onset.

Today's award aligns with the National Strategy for Pandemic Influenza Implementation Plan, which calls on HHS to develop and procure medical countermeasures for pandemic influenza or for potentially pandemic strains, such as the recent novel H1N1 flu virus.

www.hhs.gov/news

June 22, 2009--COLA announces that Cecil B. Wilson, MD, a member of the COLA Board of Directors from Winter Park, FL, has been named president-elect of the American Medical Association (AMA). Following a year-long term as president-elect, Dr. Wilson will assume the office of AMA president in June 2010.

"COLA congratulates Dr. Wilson on this great achievement," says COLA Chief Executive Officer Douglas Beigel. "Just as he has been a tremendous asset to COLA and the laboratory industry, we're confident he will be a forceful leader and advocate for the AMA on the many issues affecting the practice of medicine and patient health in the United States."

Dr. Wilson, who was appointed by the AMA to the COLA Board of Directors in July, 2005, was first elected to the AMA Board of Trustees in 2002 and served a one-year term as chair of the AMA Board of Trustees in 2006-2007. He previously chaired the AMA's Membership Committee for three years, leading efforts to focus on member involvement, effective communication and leadership on the national AMA health care advocacy agenda. Prior to being elected to the AMA Board of Trustees, Dr. Wilson served in the AMA House of Delegates for 10 years as a delegate from Florida.

An internist who has been in private practice in central Florida for over 30 years, Dr. Wilson has a distinguished record of service and leadership in organized medicine. He was president of the Florida Medical Association and chair of its Board of Governors and executive committee. He has served as president of the Orange County Medical Society and of the medical staffs of Winter Park Memorial Hospital and Florida Hospital Orlando Medical Center. He is a former chair of the American College of Physicians Board of Regents. For his dedication to organized medicine and to his patients, Dr. Wilson received the Florida Medical Association's highest honor, the Certificate of Merit and the prestigious Laureate Award from the American College of Physicians.

In addition to his role with COLA, Dr. Wilson also serves as the national fellow and advisor for the Center for Global Health and Medical Diplomacy at the University of North Florida.

Dr. Wilson received his bachelor's and medical degrees from Emory University in Atlanta. He completed his residency in internal medicine in the United States Navy. He served as a Navy flight surgeon, rising to the rank of commander. He is board-certified in internal medicine and a Master of the American College of Physicians.

Dr. Wilson and his wife, Betty Jane, have three children.

www.cola.org

June 16, 2009--The BD BACTEC FX™ microbial detection system, manufactured by Becton, Dickinson and Co. is the recipient of the 2009 Medical Design Excellence Award (MDEA) in diagnostics. This award recognizes today's top innovators in medical technology. The BD BACTEC FX is a microbial detection system used for growing and detecting microorganisms in clinical specimens. The product's ergonomically optimized design offers an efficient work flow and high-capacity output with a small footprint. Supply and design credit goes to Bresslergroup Inc., Crescent Industries Inc. and CW Thomas Inc.

The MDEA competition recognizes the achievements of medical product manufacturers, their suppliers and the many people behind the scenes--engineers, scientists, designers and clinicians--who are responsible for groundbreaking innovations that are changing the face of healthcare. The program is open worldwide to companies and individuals involved in the design, engineering, manufacturing or distribution of finished medical devices or medical packaging.

The data/result communication capabilities, automatic physician notification from the EpiCenter operating system, proven performance by the BACTEC media and aesthetics/ergonomics are key attributes that made the BD BACTEC FX excel. BD partnered with Bresslergroup, an industrial design firm in Philadelphia, to create an attractive and functional design.

BD BACTEC FX Program Manager Brad Spring says "improved laboratory workflow, ease of use and space savings are the key, innovative, attributes of the system. Because laboratory staff and space are at a premium these days, reducing the footprint and the lab's hands-on time was critical for customer acceptance of this product. I believe we not only improved workflow, but we also helped brighten the laboratory."

Today the BD BACTEC FX System maintains the performance and instrument reliability of its predecessor, the BD BACTEC 9000 System. It retains the fluorescent technology for excellence in blood culture isolate recovery along with peak instrument and media performance. BD has taken the extra step to provide a blood culture vial that is compatible with standard and readily available Vacutainer® blood collection safety adapters, which improve healthcare worker safety by reducing risk of needle-stick during blood collection and subculture. The BD BACTEC FX System has a compact and versatile system design. It offers a 200-vial benchtop unit or a full 400 vial stack with an embedded, centralized computer in a compact 24-inch linear space.

www.bd.com/ds

June 8, 2009--Clinical investigators observe that Soliris® (eculizumab), a first-in-class terminal complement inhibitor developed by Alexion Pharmaceutical Inc., reduces hemolysis (red blood cell destruction) and improves symptoms patients with paroxysmal nocturnal hemoglobinuria (PNH) who have received no blood transfusions prior to initiating Soliris therapy.

In a separate study of 11 patients with PNH, researchers observed sustained platelet recovery with Soliris treatment in a subset of seven patients with thrombocytopenia (reduced platelet levels), indicating a likely reversal of platelet consumption with Soliris in these thrombocytopenic PNH patients. These and other data sets were presented on June 6 and 7 at the European Hematology Association Congress in Berlin. Soliris is the only therapy approved in the European Union, United States, Australia and Canada for the treatment of patients with PNH, an ultra-rare, debilitating and life-threatening blood disorder.

"All patients with PNH, including those who do not require transfusion and may appear to be stable, are at increased risk for blood clots, kidney dysfunction, pulmonary hypertension and disabling fatigue caused by hemolysis," says Leonard Bell, MD, chief executive officer of Alexion. "Research presented at EHA is a sobering reminder of the clinical consequences of this progressive, ultra-rare disease. These data further underscore the clinical impact of Soliris for the treatment of patients with PNH, and also provide insight into the potential role of complement inhibition in addressing other complement-mediated diseases."

Abstract 0581 titled "Efficacy of the Complement Inhibitor Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients Never Transfused," was presented at a poster session at the EHA Congress on June 6 by Dr. Antonio Risitano, research associate at the University of Naples in Italy. Published research shows that Soliris reduces hemolysis in patients with PNH who require minimal transfusions. However, many patients with PNH do not receive blood transfusions and continue to experience hemolysis and its clinical consequences. In this analysis, investigators assessed the safety and efficacy of Soliris in the treatment of nine patients with PNH who required no transfusions prior to starting Soliris therapy. These never-transfused patients were enrolled in the Italian Early Access Program with at least one of the following conditions: severe anemia due to intravascular hemolysis, frequent paroxysmal crises, severe symptoms due to hemolysis or thrombosis (life-threatening blood clots).

All patients experienced a dramatic reduction in hemolysis following treatment with Soliris for a median of 16 months, as measured by a median reduction in LDH from 1,500 U/L before treatment to 356 U/L after treatment (p=0.008). Overall, hemoglobin levels increased significantly from 9.0 g/dL before treatment to 10.7 g/dL after treatment (p=0.0003), with a median increase of 2.0 g/dL. The investigator noted that patients reported a marked improvement in quality of life. No serious adverse events were reported.

Investigators compared these results to a subset of 21 patients previously enrolled in eculizumab clinical trials who had received zero or one transfusion during the year prior to eculizumab treatment. These patients experienced a significant reduction in hemolysis following six months of Soliris therapy, with a median reduction in LDH from 2,030 U/L before treatment to 336 U/L after treatment (p < 0.001). Hemoglobin levels increased significantly from 9.0 g/dL before treatment to 10.7 g/dL after treatment (p=0.0003), with a median increase of 1.7 g/dL. Fatigue was also significantly improved (p<0.001).

"PNH is a debilitating and life-threatening disease, even among patients who do not require blood transfusion," says Dr. Risitano. "Based on clinical data, eculizumab therapy inhibited hemolysis in these never-transfused patients, leading to immediate clinical benefit and potentially reducing the long-term morbidity and mortality associated with this ultra-rare disease."

Abstract 0584 titled "Effect of Eculizumab Therapy on Thrombocytopenia in Patients with Paroxysmal Nocturnal Hemoglobinuria," was presented at a poster session at the EHA Congress on June 6 by Ilene Ceil Weitz, MD, assistant clinical professor of medicine, Jane Anne Nohl Division of Hematology, Keck School of Medicine of the University of Southern California.

Dr. Weitz presented additional results from an ongoing prospective study to measure the effect of Soliris therapy on measures of inflammation and thrombin generation in patients with PNH. The study uses highly sensitive laboratory tests to analyze blood samples collected from patients with PNH prior to treatment with Soliris and prior to each dose during the following 90 days.

Preliminary results presented at the American Society of Hematology annual meeting in December 2008 found that patients with PNH, only one of whom had been previously diagnosed with a blood clot, exhibited a hypercoagulable state (high risk of blood clots) prior to treatment with Soliris, as indicated by elevated levels of key inflammatory and pro-thrombotic measures, including D-dimers and thrombin-antithrombin (TAT) complex.

Among the 11 patients enrolled in this study, seven had thrombocytopenia with platelet counts below 100 x 109/L (range: 26 to 88 x 109/L) prior to Soliris treatment. A sustained platelet recovery above 100,000 occurred in four out of seven patients during treatment with Soliris for periods ranging from two to 20 months. Levels of D-Dimer and TAT were elevated in all of the patients with thrombocytopenia prior to treatment, and decreased following Soliris therapy.

"These results suggest that in some patients with PNH, thrombocytopenia may be due to platelet consumption and not bone marrow failure," says Dr. Weitz. "The finding that Soliris reduces thrombin-mediated platelet consumption in these PNH patients may have implications for the treatment of patients with other complement-mediated diseases complicated by thrombocytopenia."

www.soliris.net