Killer Flu Virus Mistakenly Sent to Thousands of Labs
H2N2, an influenza virus estimated to have caused the deaths of more than 1 million people in 1957, was sent to more than 4,000 labs between September 2004 and February 2005 as part of a test kit designed to measure laboratory proficiency in identifying viruses. A Canadian lab alerted the World Health Organization (WHO) in March that its kit included the 1957 strain.

The College of American Pathologists, one of the organizations that sent out the samples from Meridian Bioscience, states that it is the association’s policy not to include in kits microorganisms that can cause harm to users. Jared Schwartz, PhD, an officer with the organization, states that Meridian thought it had sent an ordinary flu strain in its kits.

While most of the samples were sent to labs in the United States, 61 laboratories outside the country also received the virus. After being alerted about the mistake, the WHO quickly urged laboratories to destroy all samples of the virus, fearing the risk of a global outbreak.

Late last month, the WHO declared that all samples of the killer influenza virus had been located. However, the organization states that there are still some laboratories in the United States that have not confirmed the destruction of their samples. As of press time, 98% of the H2N2 samples have been destroyed.

Contact: The World Health Organization (202) 974-3000;

Bill Targets Medical Technician Shortage
The US Department of Labor Bureau of Labor Statistics estimates that 13,800 medical laboratory professionals will be needed each year through 2012 to fill vacant positions. Only 4,000 people nationwide are graduating in the field every year, and schools are graduating 30% fewer students than 10 years ago and 56% fewer students than 20 years ago.

Faced with these daunting statistics, the clinical research community has been pressed to find solutions to the shortage. US Representative John Shimkus (R-Ill) introduced a bill last month that proposes to make medical technician training more financially accessible to students.

If passed, the legislation would amend the Public Health Service Act to increase funding for the Allied Health Project Grants program, expand scholarship opportunities for disadvantaged students to include loan repayment for medical technologists and medical laboratory technicians, and authorize a grant program to provide training to increase the number of cytotechnologists.

“[The industry] isn’t getting much new blood because there are so few schools and so few numbers in the schools,” says Jean Deitz, coordinator and instructor for the Medical Laboratory Technology Program at Southwestern Illinois College (SWIC). “It’s a hard situation. We need technicians out there, and with so many of us getting ready to retire, there isn’t going to be anyone to replace us.”

Contact: Southwestern Illinois College Medical Laboratory Technology Program (618) 235-2700;

Ortho-Clinical Expands Menu for Chemistry System
Ortho-Clinical Diagnostics, a Johnson & Johnson company, has released 20 MicroTip assays for sale on the VITROS 5,1 FS chemistry system. The expanded menu enhances onboard testing capabilities to provide better workflow and workstation consolidation. Therapeutic drug-monitoring assays and serum proteins can be performed with general chemistry tests on a single system, eliminating the need to batch or split samples.

 The VITROS 5,1 FS is the first VITROS chemistry system to support the new VITROS MicroTip technology, and it provides an extended menu of proteins, therapeutic drugs, general chemistry tests, and other critical assays. MicroTip technology assays are processed using disposable tips and cuvettes, eliminating maintenance and cost associated with water, wash reagents, plumbing, drains, fixed probes, and mixing assemblies. The technology also eliminates sample and reagent carryover that occurs with sample probes, uncapped reagents, and reusable cuvettes.

The line of new MicroTip assays include Rheumatoid Factor, Apolipoprotein A1, Apolipoprotein B, Gentamicin, Tobramycin, caffeine, Vancomycin, and high-sensitivity c-reactive protein.

The VITROS caffeine assay is the only available test of its kind with clearance by the Food and Drug Administration (FDA) for the assessment of neonatal apnea. The high-sensitivity c-reactive protein assay is the first of its kind on a random access chemistry system to be cleared for use in assessing the risk of developing coronary heart disease.

The VITROS 5,1 FS chemistry system offers design advantages in addition to menu expansion. The system features MicroSlide™ technology for reportable result efficiency, Intellicheck® technology for system monitoring, advanced clot and bubble detection management, and intelligent error reduction. MicroSensor™ technology provides rapid (0.75 second), reagentless sample quality/indices assessment; and it flags only the impacted tests, saving time and minimizing the opportunity for reporting of erroneous results.

Contact: Ortho-Clinical Diagnostics (908) 218-8667;

Podiatrists Report Growing Need for Specialized Lab Services
While oncologists and gynecologists are still the most frequent users of specialized laboratory services, podiatrists are increasing the number of calls they make to independent pathology labs. Many in the field report that the rising rate of diabetes, combined with early-detection programs for the disease and better awareness and treatment options for other chronic foot conditions, have prompted podiatrists to seek the personalized service, advanced technologies, and accountability offered by smaller labs.

“There are numerous conditions of the foot that require timely and accurate laboratory analysis,” says John Jurcisin, MD, a practicing podiatrist for nearly 17 years. “Not only do we perform surgeries on the feet such as hammertoes and bunions, we also remove soft-tissue masses from the feet, and treat patients whose diabetes has led to complications of the feet. Even nonsurgical diagnoses like chronic or recurrent infections can require long-term treatment, monitoring through biopsy, and follow-up care.”

George Hollenberg, MD, New York-area pathologist, and founder of Acupath Laboratories, confirms that podiatry is a growing specialty served by independent pathology laboratories. “Monitoring such chronic conditions as diabetes and infections that affect the foot requires the treating physician and the laboratory to establish a good working relationship,” explains Hollenberg. “Because podiatrists are now forming long-term relationships with their patients, they need reliable and accountable service that can help them enhance that relationship.”

According to Jurcisin, the lab report is the bridge that connects the pathologist’s findings to the treating physician. Yet, some podiatrists have encountered wide gaps between the diagnosis and the findings when using larger labs.

“In the past, I’ve sent tissue samples for biopsy and included the proper diagnosis,” explains Jurcisin. “The report came back very generalized, with no specific information about the diagnosis.”

In an effort to prevent problems such as communication gaps between the podiatrist and the pathology lab, laboratories such as Acupath require two separate reviews of every laboratory analysis. They have also instituted a system that locks the report when it is approved. This process prevents any changes or deletions before the sample is delivered to the treating physician. Additionally, Acupath generates a patient-friendly letter for each report, which the treating physician can share during a consultation with the patient to explain the diagnoses, lab findings, causes, and treatment options.

“The prevailing reason for choosing to work with an independent pathology lab is that both the doctor and the staff can build a rapport that you just can’t find at the bigger labs,” says Lori Weisenfeld, MD, a New York-area podiatrist. “That makes everything much easier.”

Contact: Acupath Laboratories Inc (888) 228-7284;

Sigma-Aldrich Joins RNAi Consortium
To expand its move into functional genomics, Sigma-Aldrich Corp has entered into an agreement with the Massachusetts Institute of Technology (MIT) to serve as a scientific collaborator and distribution partner in The RNAi Consortium (TRC). The consortium, based at The Broad Institute in Boston, is made up of seven research institutes and four commercial partners. Over the next 3 years, the consortium’s goal is to create a comprehensive library of RNA interference (RNAi) reagents designed to reduce expression of specific human and mouse genes, thereby enabling scientists to elucidate the function of the targeted gene. In addition to participating as a sponsoring member of the consortium, Sigma-Aldrich will commercially distribute clones, purified DNA, and viral stocks from the RNAi libraries, facilitating their use by researchers worldwide.

The consortium involves scientific collaborations between principal investigators at seven research institutions: Massachusetts General Hospital, Harvard Medical School, Dana-Farber Cancer Institute, The Broad Institute, Whitehead Institute for Biomedical Research, Massachusetts Institute of Technology, and Academia Sinica. In addition to Sigma-Aldrich, TRC also includes corporate partners Bristol-Myers Squibb, Eli Lilly, and Novartis.

The RNAi research reagents created by the consortium will enable biomedical researchers to discover the key genes that underly normal physiology as well as disease states. It is widely believed that RNAi will revolutionize the way in which life science research is conducted, and it is expected that RNAi will have a major impact on the understanding of the genetic basis of diseases such as cancer, arthritis, and Alzheimer’s.

“We are very excited to participate in the development of these reagents and to make them available to the entire biomedical research community,” says Dave Julien, president of the biotechnology division at Sigma-Aldrich. “This collaboration is a wonderful opportunity to participate in an important scientific undertaking while furthering our goal of providing cutting-edge tools to enable life science research.”

Contact: Sigma-Aldrich Corp (800) 521-8956;

ITC Awarded Novation Contract
 International Technidyne Corp (ITC), a subsidiary of Thoratec Corp, has signed a 36-month multi-source agreement with Novation, the supply company of VHA Inc and the University Health System Consortium (UHC). Under the terms of the agreement, ITC will provide Novation access to its HEMOCHRON product line for blood-coagulation monitoring in the operating room, the cardiac catheterization lab, the oral anticoagulation clinic, and other point-of-care locations. ITC will also provide its ProTime system for alternate-site (nonhospital) testing. Both product lines are designed for patients who require frequent blood testing and monitoring due to oral anticoagulant medication, and for quickly and efficiently monitoring blood-coagulation status during cardiac bypass surgery, valve-replacement surgery, and interventional catheterization procedures.

“It’s a great privilege and excellent growth opportunity for ITC to make its products available through Novation, and this agreement is further evidence that the HEMOCHRON and ProTime systems have become the standard for point-of-care coagulation monitoring,” says ITC President Lawrence Cohen.

HEMOCHRON Response is a tube-based, whole-blood-coagulation-monitoring instrument that is capable of performing 12 routine and specialty tests at various point-of-care locations. The HEMOCHRON Signature line of instruments are low-blood-volume, cuvette-based systems capable of performing six different whole- and citrated whole-blood tests.

The HEMOCHRON line of instruments also have compliance features that include enhanced operator lockout options, multiple levels of quality control, the ability to add user notes to test results, and an increased number of stored operator-identification numbers and quality-control records. These and other features provide flexibility to fit the users’ needs and ensure compliance with laboratory regulations. Programs such as idms and HEMOCHRON Response Data Manager enable capturing, managing, and transferring of critical data into laboratory and hospital databases.

Contact: International Technidyne Corp (800) 631-5945;

Global Med Technologies Announces Milestone
Wyndgate Technologies®, a division of Global Med Technologies®, has announced the installation of its SafeTrace® donor management system and SafeTrace Tx® transfusion management system in more than 300 blood centers, hospitals, hospital networks, and centralized transfusion services, both domestically and internationally.

“Global Med Technologies has reached yet another of its projected milestones—contracting and implementing our donor management and transfusion-management software products in more than 300 facilities,” says Michael I. Ruxin, MD, chairman and CEO of Global Med Technologies. “Quality and safety have been the foundation for our success in providing high-quality products and services through continuous improvement. Our success is proven by our loyal customer base, as well as our growing list of prestigious new clients in the United States and internationally. Our next milestone is 500 sites, and we have more than enough prospects in the pipeline to see that business materializing in the foreseeable future.”

Wyndgate Technologies developed the SafeTrace Tx advanced transfusion-management system in collaboration with the Institute for Transfusion Medicine in Pittsburgh. SafeTrace TX is a Microsoft® Windows®-based, feature-rich hospital transfusion service-management system.

SafeTrace’s features include donor management, from recruitment and collection through testing, labeling, and final distribution.

Contact: Global Med Technologies Inc (800) 996-4283;

Gen-Probe Receives Tentative Award in Arbitration
Gen-Probe recently announced that it has received a tentative award in its arbitration with Bayer HealthCare LLC. The arbitration addressed the collaboration between the two companies in the development and sale of a nucleic acid diagnostic test for viral organisms.

The result of the arbitration determined that Gen-Probe is entitled to coexclusive rights to distribute the qualitative TMA assays that detect the hepatitis C virus and HIV-1. Bayer previously held the exclusive rights to market these products.

The arbitration also determined that the collaboration agreement should be prospectively terminated, as requested by Gen-Probe. As a result of terminating the agreement, Gen-Probe will have the right to develop and market future viral assays that had been previously reserved for Bayer. Bayer will retain coexclusive rights to distribute two products that the company currently markets. Bayer also will be required to reimburse Gen-Probe $2 million for its legal fees and expenses related to the arbitration proceedings.

The presiding arbitrator rejected Bayer’s multimillion-dollar counterclaim for damages. The tentative decision is subject to further proceedings related to implementation of the decision.

Gen-Probe initiated the arbitration in November 2002, pursuant to the terms of the parties’ 1998 collaboration agreement. Bayer filed its counterclaims in November 2003.

Contact: Gen-Probe (800) 523-5001; 

Utah Newborns to Receive Additional Testing
Beginning January 2006, the Utah Department of Health (UDOH) will begin testing all Utah newborns for 36 metabolic diseases. Currently, newborns in Utah are tested for four disorders that otherwise might not be detected until signs and symptoms appear, which is often too late to prevent disability or death.

“The expanded newborn screening will help pediatricians and other health care providers identify rare disorders that easily can be confused with common pediatric problems,” says Nicola Longo, MD, PhD, professor of pediatric genetics at the University of Utah School of Medicine. “Diagnosing and treating these conditions will help us prevent elements such as irreversible brain damage, permanent disabilities, and possibly death.”

The expansion of newborn screening in Utah is made possible by recent legislation that increased the allowable fee the UDOH charges hospitals for newborn screening kits from $35 to $65. The organization is moving forward to implement system changes to ensure that all infants born in the state receive the expanded screening and appropriate follow-up care. Changes include upgrading the current newborn screening computer software, amending the state’s newborn screening rule, developing educational materials for health care professionals and families, and updating the current newborn screening specimen-collection forms.

 As part of its preparation for the expanded screening, the UDOH began a pilot program in October 2003 with ARUP Laboratories and the University of Utah Hospital. The pilot project helped establish appropriate and timely follow-up procedures between the public health and private health care providers. The success of the pilot program enabled the UDOH to implement statewide system changes.

“The pilot program showed that expanded newborn screening and timely follow-up could be successful with collaboration and cooperation between public health and private health care sectors,” says David Sundwall, MD, executive director of the UDOH. “This partnership has strengthened a basic public health program and greatly enhances the health of newborns in Utah.”

The new tests that will be added to the newborn screening panel include congenital adrenal hyperplasia; biotinidase deficiency; amino acid disorders, including maple syrup urine disease; organic acid disorders; and fatty acid oxidation disorders, the most common of which is medium chain Acyl-CoA dehydrogenase deficiency.

Contact: Utah Department of Health (801) 584-8410;

Kreatech Biotechnology BV and GE Healthcare Announce Agreement
Based on a new agreement between Kreatech Biotechnology BV and GE Healthcare, Kreatech is now able to market DNA microarray labeling kits with its proprietary Universal Linkage System (ULS™) and GE Healthcare’s Cy3 and Cy5 dyes for the life science research marketplace. The coupling of the ULS technology and the CyDyes will enable Kreatech to offer researchers direct DNA labeling with ULS, which eliminates the need for modified nucleotides with the preferred fluorescent label.

“This agreement is the result of a relationship that has developed over the last several years,” says Lex Altink, CEO, Kreatech Biotechnology BV. “[The agreement] enables us to deliver a unique product to researchers with the preferred fluorescent label and the advantages of direct, nonenzymatic labeling.”

Another term of the agreement is that Kreatech will develop and manufacture microarray labeling kits for amplified RNA labeling and genomic DNA labeling for DNA microarrays and array CGH applications.

Contact: Kreatech Biotechnology (858) 794-0226;

 Leica Takes New Direction with Marketing Campaign
Leica Microsystems recently launched a campaign that highlights the company’s line of specimen-preparation products and how it benefits individual users in their daily work. The campaign, titled “Designed with You in Mind,” has been developed to reach Leica Microsystems customers in a more personal way through matching product benefits to actual laboratory duties. Elements of the human body are portrayed in black-and-white tableaus that appeal to the senses and illustrate how Leica products are designed to make histology easy, fast, accurate, comfortable, and safe.

For the past several years, Leica’s tagline has been “Advancing Traditional Histology.” With the new marketing focus, the company is further expressing the way technology interfaces with real-world users to enhance their work and achieve unique personal benefits.

Contact: Leica Microsystems (800) 248-0123;

The Number of Children Screened for Lead in Michigan County Doubles
Using the LeadCare® blood lead testing system from ESA Biosciences Inc, officials in Michigan’s Muskegon County Health Department have been able to screen twice as many area children for lead poisoning, according to Carolyn Warren, Muskegon County public health nurse.

“During the second quarter of 2004, for example, we screened nearly twelve hundred children for lead, compared to about 600 for the same quarter in the previous year,” says Warren. “This dramatic increase clearly can be attributed to the LeadCare system, which makes the screening procedure simple, easy, and fast.”

According to Warren, the main advantage of the LeadCare system is that it gives parents immediate results. “Parents really appreciate knowing right away if their child has any elevated lead levels,” adds Warren.

Using the LeadCare test, blood is taken from the same finger-poke sample as the child’s hemoglobin test, which is required annually by the Women, Infants and Children (WIC) program. LeadCare eliminates virtually all reasons for not having a lead test, resulting in more screened children.

“Portability is another key advantage of LeadCare,” says Warren. “It brings screening to the people.” According to Warren, Muskegon County Health Department officials often take the portable LeadCare analyzers on the road, visiting health fairs and other Head Start sites throughout the county for on-location screening. “You can’t do this with the larger, more conventional equipment,” adds Warren.

Contact: ESA Bioscience Inc (978) 250-7000;

Uniflex Acquired By Brynwood Partners
Uniflex Inc, the manufacturer and marketer of hospital and laboratory bags, including Speci-Gard® specimen-transport bags, has been acquired by Brynwood Partners, a private-equity firm based in Greenwich, Conn. The alliance will serve to strengthen Uniflex’s position as the premier designer, manufacturer, and marketer of customized bags to the laboratory and hospital purchasing markets, according to Vince Schaller, the newly appointed president and CEO of Uniflex.

“Now that the acquisition is complete, our first priority is to let the medical industry know that Uniflex is leaner, stronger, and more committed than ever to manufacturing and delivering medical packaging products that meet and exceed expectations. Currently, we are significantly enlarging our sales force to ensure our ability to provide top-notch service to our customers throughout the country,” Schaller says.

Contact: Uniflex Inc(800) 223-0564;

bioMerieux Will Have Key Role in Platelet-Collection System
bioMerieux’s BacT/ALERT® 3D microbial-detection system will play an integral role in a leading single-donor-platelet technology system. Gambro BCT Inc recently received Food and Drug Administration (FDA) clearance for apheresis platelets to be collected with its Trima® and COBE Spectra™ collection systems for routine storage and patient transfusion up to 7 days. Clearance was obtained on the condition that the platelets are tested with the BacT/ALERT microbial-detection system, and are used as described in the Gambro BCT 7-day platelet protocol.

The FDA clearance will now allow blood banks that use the Gambro BCT system to store single-donor platelets for up to 7 days. Previously, platelets had to be transferred within 5 days of collection due to concerns about bacterial contamination. The short shelf life of platelets creates continuing challenges for blood suppliers to meet transfusion needs. The 2-day extension of platelet shelf life will have a positive impact on platelet safety in the United States.

“Bacterial contamination of blood is a serious threat, and the blood community is very diligent about advancing testing of blood components for aerobic and anaerobic organisms,” says Eric Bouvier, president and CEO, bioMerieux Inc. “BacT/ALERT is a proven system that is currently being used by most US blood banks for testing microbial contamination, and we’re very proud of BacT/ALERT’s role in such a significant advancement in platelet shelf life.”

BacT/ALERT 3D is an automated microbial detection system that integrates blood, sterile body fluid, and mycobacteria culturing. In addition to its space-saving modular design, touch-screen operation, and flexible data-management options, BacT/ALERT 3D utilizes industry-exclusive plastic BacT/ALERT bottles. These are designed to help laboratories better adhere to the US Department of Occupational Safety and Health Administration (OSHA) Blood Borne Pathogens Standard and other regulatory mandates. The BacT/ALERT bottles are designed to help protect laboratory and hospital staff from the risk of hazardous sharp exposure and accidental injury.

Contact: bioMerieux (919) 832-6300;

Lab Test Could Help Detect Low Kidney Function
A recent study conducted at the University of Western Ontario has revealed that the results of routine laboratory tests performed for other reasons could provide a new approach to identifying patients with reduced kidney function.

Researchers gathered the results of kidney-function tests in adult patients from 17 outpatient laboratories serving Eastern Ontario. Because the focus was on identifying unsuspected abnormalities, patients with kidney failure requiring dialysis were excluded. The final analysis included tests from almost 350,000 individuals. Nearly half of the patient results showed an abnormally low glomerular filtration rate (GFR), a standard measure of kidney function. Thus, about 16% of adults in the population (about 1 in 6) had reduced kidney function.

More than two-thirds of patients who underwent repeated tests in the same month had similar results on both occasions. This suggested that the abnormal GFR results signaled true reductions in kidney function, rather than temporary drops due to disease or other causes.

According to researchers, early identification of chronic kidney disease (CKD) is a major health care priority, because effective treatments can slow or prevent progressive kidney disease. Moreover, CKD is recognized as a major risk factor for the development of cardiovascular diseases such as heart attack and stroke. Early treatment of CKD has been shown to reduce the risk of later development of cardiovascular disease. However, many cases of CKD go undetected during routine medical care.

Based on the results of the study, researchers propose that laboratory-initiated screening could provide an innovative approach to identifying patients with CKD. Since kidney-function tests are routinely performed for other reasons, laboratory-based screening could use existing data to identify patients at risk of both kidney and heart disease.

Contact: The American Society of Nephrology (202) 659-0599;

Mediware Announces $1,000 Scholarship for SBB Certification
Mediware Information Systems Inc is offering a new scholarship program for all medical technologists enrolled in a specialists blood banking certification program. The award was developed to recognize dedication and excellence in the field of blood banking.

Recipients will be selected based on a 1,000-word essay that discusses the impact blood bank software systems have on transfusion medicine and patient safety. The deadline for submissions is set for September 30, 2005.

“Patient safety is the most critical factor in today’s hospital environment,” says Frank Poggio, initiator of the scholarship and vice president and general manager of Mediware’s Blood Bank division. “We believe that contributing to the higher education of today’s blood banking community in turn contributes to patient safety.”

Contact: Mediware Information Systems Inc (516) 962-0100;