Nanogen and Pathway Diagnostics Sign License Agreement
In an effort to develop optimal drug regimens and dosing strategies for therapeutic options used by patients suffering from psychiatric diseases, Nanogen Inc and Pathway Diagnostics have entered into a nonexclusive, worldwide license agreement to develop diagnostic products that detect genetic variations associated with responses to antidepressant and antipsychotic therapeutics. The companies have begun work on developing a molecular diagnostic product that will be used to select the most appropriate drug and dosage for patients treated for psychiatric diseases.

“We are optimistic that Nanogen’s partnership with Pathway Diagnostics will result in exciting products that will contribute to more personalized medical treatments,” says Howard C. Birndorf, chairman of the board and CEO of Nanogen. “Because our NanoChip® platform can simultaneously analyze multiple genetic markers, we have the capability to develop a diagnostic panel to detect these newly licensed genetic variations, along with genes in the cytochrome P450 family that are related to drug metabolism, to allow the physician to prescribe the right drug at the right dosage.”

According to Nanogen, schizophrenia affects more than two million Americans each year, and depression affects more than 20 million people. Although many therapeutic options are available for patients suffering from these conditions, the side effects of drug therapy can be unpleasant—and even life-threatening for some patients. Determining optimal drug regimens and dosing strategies are challenges currently addressed by trial-and-error prescribing practices. Side effects may be caused by a variety of factors, including variations in genes that are targets of the drugs or the genes that are involved in drug response. In addition to the negative effect on an individual’s health, significant direct and indirect costs are associated with these adverse drug responses.

Contact: Nanogen Inc (877) 626-6436;

Roche Contracts with Novation for Point-of-Care Coagulation Testing
Roche Diagnostics has signed a 3-year contract with Novation, the supply company of VHA Inc and University Health System Consortium (UHC). The contract enables VHA and UHC members to draw upon Roche’s portfolio of total solutions to increase efficiency while enhancing services to their physicians. These services include timely and actionable information for patient management, which leads to better patient outcomes.

Roche Diagnostics is currently under contract with Novation for blood gas, blood glucose monitoring, chemistry, and immunochemistry products, in addition to the coagulation products. This means Roche is one of the largest laboratory and point-of-care vendors for Novation.

Contact: Roche Diagnostics (317) 845-2000;

Study Points to Sensitive Influenza Test
Scientists at the University of Rochester Medical Center found that the QuickVue® Influenza A+B assay from Quidel Corp demonstrated a high analytical sensitivity among tests examined for their effectiveness in detecting the influenza virus.

 “The objective of our study was to give clinicians a clear understanding of the comparative performance of rapid influenza tests currently available,” says Melinda Nye, PhD and clinical microbiology fellow at the University of Rochester Medical Center. “After a thorough evaluation, the QuickVue influenza A+B test clearly outperformed in terms of analytical sensitivity, ease of use, and rapid time to result. Although we might predict a more analytically sensitive test to be more sensitive with patient specimens, these studies need to be done separately.”

After the accidental release of the deadly H2N2 influenza virus to laboratories earlier this year, concerns about a potential influenza pandemic have been growing. In these circumstances, many feel that it is essential for the clinical community to have a rapid test that will allow them to quickly identify patients infected with the influenza virus to help control the spread of infection. Knowing which test has the highest sensitivity arms the clinical and public health communities with the information they need to choose the best influenza virus-detection test.

Contact: Quidel Corp (800) 874-1517;

 Global Med Technologies Expands Worldwide
Wyndgate Technologies recently announced that it has installed its SafeTrace® donor-management system and SafeTrace Tx® transfusion-management system in more than 300 blood centers, hospitals, hospital networks, and centralized transfusion services around the world.

Wyndgate Technologies developed the SafeTrace Tx advanced transfusion-management system in collaboration with the Institute for Transfusion Medicine in Pittsburgh. SafeTrace Tx is a Windows®-based hospital transfusion service-management system designed to support enterprise-wide centralized transfusion services management.

Each year, Wyndgate clients manage more than three million units of blood, which is more than 22% of the US blood supply. The combination of SafeTrace and SafeTrace Tx provides Vein-to-Vein® tracking from donor collection to patient transfusion.

Internationally, Global Med is making headway with system installations. The company recently installed its SafeTrace donor-management system in a second blood center in Africa. The placement of the technology in sub-Sahara Africa, and other underdeveloped countries, will help upgrade and secure local blood supplies.

According to Wyndgate, blood centers in underdeveloped countries face challenges beyond those in technologically advanced countries. Blood shortages are a concern; however, the blood supply is at a greater risk of possible contamination with blood-borne diseases, such as AIDS, hepatitis, and syphilis. The spread of AIDS, in particular, has become the driving force behind the current initiatives to improve the environment in which blood is collected and tested, which may in turn help to decrease the transmission rate of HIV/AIDS through blood transfusions in these countries. Replacing their manual processes and manual records with automated solutions can help to manage their donor testing and help to ensure the safe release of blood and blood products for transfusion.

“We were able to provide a relatively low-cost solution that is suited to the technologically challenged African environment in a relatively short period of time,” says Will Willman, senior vice president of International Business Development for Global Med. “Data that is entered by the blood center staff in Africa is transmitted securely via satellite to a data center located in Denver. The staff at this data center provides all of the computer-system support, including database management and monitoring, which greatly reduces the complexity and cost of providing this solution for a blood center in Africa.”

In the United States, Wyndgate recently signed an agreement with Suncoast Communities Blood Bank (SCBB) to provide its SafeTrace donor-management system to all SCBB facilities.

“Our staff selected Wyndgate’s SafeTrace donor-management system for its safety features, as well as its application capabilities, which facilitate the automation of many of the manual processes currently being performed in our donor service,” says Mark Magenheim, MD, MPH, CEO, and medical director of Suncoast Communities Blood Bank.

Contact: Global Med Technologies Inc (800) 996-34283;

ESA’s Kit Adopted by Major Clinical Reference Labs
The plasma metanephrine analysis kit from ESA Biosciences Inc, which has been approved by the Food and Drug Administration (FDA), has been adopted by several major clinical reference laboratories throughout the United States. The kit enables laboratories to detect the presence of pheochromocytomas with far more sensitivity than traditional assays.

 The new product from ESA extracts free metanephrine and normetanephrine from plasma for HPLC-electrochemical-detection analysis of the catecholamines’ metabolites. Pheochromocytomas are chromaffin cell tumors that generally arise in the adrenal glands, and they are characterized by excessive production of catecholamines, which can lead to hypertension and to a fatal illness if left undiagnosed or untreated.

“Adoption of the kit by some of the largest medical and clinical reference laboratory companies in the country is evidence of the validity of its state-of-the-art approach to metanephrine analysis,” says John Christensen, ESA vice president. “Our kit means the difference between accurately detecting a life-threatening disease or misdiagnosing it.”

The significant advantages of the ESA technique stem from the more direct correlation of plasma-free metanephrine concentration to the catecholamine and metanephrine production of adrenomedullary and pheochromocytoma cells than from other sources. The new ESA method is sensitive enough to detect all but the smallest of pheochromocytomas, and yield fewer false-negative results. Therefore, a negative test result virtually rules out the presence of pheochromocytoma.

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

 Bayer Announces Sixth FDA-Approved Hepatitis Assay
Bayer HealthCare, Diagnostics Division, has received approval from the Food and Drug Administration (FDA) for its sixth automated hepatitis assay on its ADVIA Centaur® Immunoassay System. The FDA approved the company’s assay for Hepatitis A (HAV) Total, an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to the hepatitis A virus in human serum or plasma. The assay can be used by laboratories to aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination.

“[The approval of the assay for HAV Total] meets our customers’ demands for practical assays that enhance the efficiency and value of their laboratories,” says John Nosenzo, senior vice president and general manager of the North America region for Bayer HealthCare, Diagnostics Division.

Bayer Diagnostics offers the HAV Total assay on the ADVIA Centaur Immunoassay System, which makes the hepatitis panel ideal for medium-volume and large-volume laboratories. The addition of this assay to the platform allows laboratorians to enhance their level of automation in performing assays. It offers such features as software that provides automatic algorithm processing, cascade reflex testing, user-defined panels, automatic repeats of critical samples, and sample and reagent integrity checks.

Contact: Bayer HealthCare, Diagnostics Division (914) 631-8000;

 Frost & Sullivan Recognizes TREK
This year, Frost & Sullivan awarded its Product Leadership Award in the field of microbial detection to TREK Diagnostic Systems for the development of its VersaTREK® Automated Microbial Detection System. This award recognizes the company’s adoption or invention of new technology, its product-development strategies, and the degree to which the product has met customer needs and requirements.

To choose the award recipient, Frost & Sullivan’s analyst team tracked developments in a particular field of technology using a set of predetermined qualitative and quantitative measurements. The selection process included interviews with primary participants and/or end-users, distributors, and suppliers; as well as extensive primary and secondary research via the bottom-up approach. A nominee’s products are analyzed based on their degree of innovation, their estimated market-penetration rate, and their acceptance by intended end-users. Industry participants are ranked, and the top-performing company is chosen to receive the award.

Contact: TREK Diagnostic Systems (800) 871-8909;

Misys Healthcare Systems Enhances New York State Laboratory Reporting
Misys Healthcare Systems recently announced the activation of its Misys Laboratory–Disease Reporting Interface™, a connectivity solution designed to transmit infectious disease data to state electronic laboratory reporting databases. The solution allows public health officials to track and predict communicable diseases and to react immediately to bioterrorism, chemical terrorism, and other public health emergencies.

The New York State Department of Health, which collects patient data from several Misys New York-based clients, is among the first to activate the interfacing solution to improve the transmission of infectious disease reporting to its state and local health departments.

“Misys Laboratory–Disease Reporting Interface, once installed at hospitals, increases the timeliness of communicable disease reporting,” says Kevin McDonald, product manager of interfacing at Misys Healthcare Systems. “The advanced technology benefits the public because health-department officials can react quicker to specific disease outbreaks, which leads to improved care and a healthier patient population. Health officials also can follow up more closely on individual patients.”

For more than a century, state clinical laboratories have reported to state public health authorities the presence of certain diseases and conditions considered serious threats to public health. Most state health departments’ reporting systems are manual and use paper-based reporting methods.

The Misys interfacing connectivity solution aggregates reportable disease conditions from a hospital laboratory system and transmits the information in a single data set to a state department of health database. The data is then dispersed to statewide health departments and to the Centers for Disease Control and Prevention’s National Electronic Disease Surveillance System (NEDSS). NEDSS is a public health initiative that provides a standards-based, integrated approach to disease surveillance. A primary goal of NEDSS is the ongoing, automatic capture and analysis of data already available electronically.

“The Misys Laboratory–Disease Reporting Interface decreases the hospital lab’s manpower hours required to comply with state-level infectious disease-reporting requirements,” says McDonald. “The solution’s decentralized architecture approach ensures that the data goes directly to the state health department versus a third-party data center.”

Contact: Misys Healthcare Systems (866) 647-9787;

Magellan Biosciences Acquires TekCel
Magellan Biosciences, a provider of instruments, automated systems, point-of-care products, and consumables for biomedical research and clinical diagnostics, has acquired TekCel, an innovator of sample-management and assay-automation systems for biomedical research. Terms of the transaction were not disclosed.

“With the acquisition of TekCel, Magellan can now take advantage of opportunities that are beyond the reach of smaller enterprises,” says Robert J. Rosenthal, president and CEO of Magellan. “Our goal is to deliver consistent profitable growth through our own internal product development and selective acquisitions. With revenues now at nearly $50 million, we can afford to invest in the advanced systems and infrastructure necessary to build a world-class company, which will help us serve our customers even better.”

Contact: Magellan Biosciences (978) 250-7000;

New Prototype Urine Test Shows Promise for Diagnosing Prostate Cancer
Gen-Probe’s prototype urine test for PCA3 gene expression may help improve the diagnosis of prostate cancer, according to a study by researchers at the University of California, Los Angeles (UCLA).

Initial preclinical research has shown that the PCA3 gene is overexpressed only in malignant prostate tissue. Gen-Probe’s prototype APTIMA PCA3 test may, therefore, prove superior to prostate-specific antigen (PSA) testing in certain clinical situations. Because PSA is produced by both malignant and nonmalignant tissue, PSA tests tend to produce many false-positive results that cannot be confirmed by biopsy.

“The promising results of these initial studies are consistent with our performance targets for the APTIMA PCA3 assay, and give us confidence in our ongoing and future research,” says Harry Rittenhouse, PhD, senior director of cancer research for Gen-Probe.

The study assessed the ability of physicians to collect informative urine samples that could be tested for PCA3 messenger RNA (mRNA) expression levels. Physicians collected urine samples from men before and after an attentive digital rectal exam (DRE), which involves three sweeps on each side of the prostate. The men were divided into three groups: those less than 50 years old with no known prostate disease; those undergoing prostate biopsy; and those who had undergone radical prostatectomy more than 1 year before the study. The third group of men served as controls.

Researchers defined informative samples as those having sufficient prostate cells to yield a valid clinical result, as measured by PSA mRNA expression. After the attentive DRE, PSA gene expression could be quantified from all the samples collected. Samples that were collected before the DRE had a lower level of PSA mRNA expression, yet still demonstrated an informative test rate approaching 90%.

“One challenge for molecular urine tests is obtaining enough prostate cells to ensure a valid result,” says Leonard Marks, MD, clinical associate professor of urology at UCLA and lead author of the study. “In this study, combining an attentive DRE with Gen-Probe’s molecular-detection technologies yielded an informative rate of 100%. This high informative rate provides an advantage over other methods of molecular detection in urine, and reduces the number of repeat specimen collections required. Significantly, results from patients in the postprostatectomy control group showed that PSA and PCA3 mRNA were nearly undetectable.”

For urine samples collected after a DRE, sensitivity and specificity of the prototype APTIMA PCA3 assay were 66% and 75%, respectively, when the ratio of PCA3 to PSA mRNA was used to determine the presence of cancer. Similar results were obtained using pelleted samples.

Gen-Probe acquired exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure in November 2003. The companies maintain a license and collaboration agreement under which they are developing, and Gen-Probe will market, the APTIMA PCA3 assay.

Contact: Gen-Probe (800) 523-5001;

 McBain Instruments Celebrates 40 Years in Microscopy
For the past 40 years, McBain Instruments has been supplying the industrial, biomedical, and life sciences markets with laboratory microscopy systems and custom-engineered optical instruments.

The privately held firm was founded in 1965 by Carl McBain. Starting with microscope service and repair, McBain created a sales division and began engineering custom imaging systems. In 1983, McBain sold a portion of the company to Warner-Lambert but retained the sales and distribution segments. Today, McBain remains active in the business, consulting with the current president and CEO, Michael Crump, who joined the company in 1997.

Contact: McBain Instruments (818) 998-2702;

 Upstate Group to Sell UC’s Monoclonal Antibody
Serologicals Corp recently announced that Upstate Group, its wholly owned subsidiary, obtained rights from the University of California to sell the anti-ZAP-70 monoclonal antibody for diagnostic use. Studies show that levels of expression of the ZAP-70 protein strongly predict the aggressiveness of chronic lymphocytic leukemia. Scientists have used anti-ZAP-70 in immunohistochemistry, flow cytometry, and Western blot analysis of samples from chronic lymphocytic leukemia patients.

“Anti-ZAP-70 was formerly only available for research use,” says Ian Ratcliffe, president of Upstate. “The recently obtained rights will allow us to work more closely with diagnostic companies active in cell signaling.”

Upstate anticipates significant growth potential from the anti-ZAP-70 monoclonal antibody, including the development of ZAP-70 diagnostic kits; the development of ZAP-70 as a biomarker; and the ability to offer Good Manufacturing Practice (GMP)-approved ZAP-70 quantities.

Contact: Upstate Group (800) 233-3991;