Atlas Medical Software to Help Sponsor 2004 Lab Institute
Atlas Medical Software will be a platinum sponsor of the G-2 Reports’ 2004 Lab Institute, September 29–October 2 in Arlington, Va.

The mission of the G-2 conference is to guide hospital, lab, and pathology professionals in developing, implementing, and revising compliance programs to meet federal standards. Attendees will receive the practical advice and information they need to stay current with changing federal mandates, structure business arrangements to prevent fines, reduce exposure to whistle-blower lawsuits, maintain public trust, and thwart negative publicity. With the continued emphasis on health care fraud by various government agencies, the information presented at this conference is designed to help attendees avoid the pitfalls that can lead to an investigation.

Contact: Atlas Medical Software (818) 224-6238

Sysmex Automation System Redefines Hematology Process

Kaiser Permanente Regional Laboratories has implemented Sysmex’s MOLIS WAM hematology automation system at its Northern California regional laboratory.

The first of its kind to be installed in the US, the automation system consists of three lines of hematology instrumentation for a total of 10 analyzers. This will enable Kaiser Permanente to double its current capacity of sample processing to as many as 10,000 samples daily without increasing laboratory technologist staff.

“We were motivated to make a change in hematology due to the need to replace older instrument technology and in anticipation of expected growth,” says Jaime Vergara, manager of cell pathology at the Kaiser Permanente’s Northern California lab. “With the current technologist labor shortage, we have difficulty finding trained and licensed technologists. We needed an automated hematology system that would help us address this problem and position us for growth.”

The new MOLIS WAM intelligence layer is a work area management system that provides rule-based decision logic. The system automates data and sample management that reduces manual processing throughout the hematology section. MOLIS WAM allows specimens to be automatically tracked throughout the hematology workflow, while moving test tubes between the primary HST line and the repeat line with no manual intervention. Specimens can be tracked at the rack and rack-position level, allowing the hematology process to become more defined.

Contact: Sysmex America Inc
(800) 379-7639

Ortho-Clinical Diagnostics Issues Voluntary Recall for Cardiac Marker

A nationwide recall of four lots of VITROS® Immunodiagnostic Products Troponin I Reagent Pack was issued early last month by Ortho-Clinical Diagnostics. The company received complaints of random occurrences of false-positive results, which could lead to unnecessary medical procedures. An investigation by Ortho-Clinical diagnostics determined that the occurrences were limited to an interaction between a component in the affected lots of specific patient plasma samples. All current and future lots are undergoing enhanced testing designed to screen for this potential interaction.

The recall includes VITROS Immunodiagnostic Products Troponin I Reagent Pack (1949882) lots 1110 and 1130 as well as VITROS Immunodiagnostic Products Troponin I Reagent Pack (6801857) lots 2510 and 2530.

Although no injuries had been reported, the company asked that clinical laboratories stop using the recalled products and discard any remaining material, and notify the health care provider who ordered the test. Ortho-Clinical Diagnostics provided replacement products.

Contact: Ortho-Clinical Diagnostics (800) 421-3311

Beckman Coulter Encourages Blood Tests for Use in Detecting and Monitoring Prostate Cancer
New guidelines from the independent National Comprehensive Cancer Network (NCCN) strongly support the prostate specific antigen (PSA) and percent-free PSA blood tests to aid in the detection and treatment of prostate cancer. Beckman Coulter’s Hybritech PSA and Hybritech free PSA were the first such tests approved by the FDA.

The NCCN, an alliance of 19 leading cancer centers, states that the development of PSA testing is arguably the most important advance in detecting prostate cancer at an early stage. Prostate cancer cases detected through PSA screening are more often confined to the prostate than those detected solely by a digital rectum exam, meaning PSA-detected cancers are less likely to have spread to other parts of the body.

“PSA is more accurate for prostate cancer than mammograms are for detecting breast cancer,” says William Catalona, MD, director of the Clinical Prostate Cancer Screening Program at Northwestern Memorial Hospital in Chicago. “It is the best cancer tumor marker used today.”

The new NCCN guidelines also recommend the appropriate age to begin PSA testing, the value of percent-free PSA testing, and the potential advantages of monitoring the rise in a man’s PSA level from one year to the next. PSA as a screening test is used to determine which men have a significant cancer risk, and who should therefore receive a prostate biopsy to confirm the presence of cancer.

Although the results of using PSA to aid in the detection and treatment of prostate cancer have received acclaim, some contend that PSA testing may not be as accurate or as valuable as previously thought. Critics fear that the test leads to too many unnecessary biopsies of cancers that often are not life threatening.

“There are appreciable differences between prostate cancer tests,” says Catalona. “It is important to get PSA levels checked annually using the same test at the same facility. If you use different tests from one year to the next, you can get different PSA results, which could lead to inaccurate diagnosis and treatment.”

Contact: Beckman Coulter (800) 352-3433

 Chembio Contributes to the Fight Against AIDS
Chembio Diagnostics Inc has commenced clinical trials of its Sure Check™ HIV and HIV Stat-Pak proprietary lateral flow rapid tests for the detection of antibodies to HIV in finger-stick whole blood, serum, or plasma.

Sure Check HIV and HIV Stat-Pak are used as a means of screening for HIV and facilitating further preventative measures. By producing results in less than 15 minutes at the point of care, the number of people who receive test results increases. The reduced time it takes to receive results significantly reduces the risk of infected people spreading the virus. The tests have been included in evaluations with the US Centers for Disease Control, and the company has initiated strategies to have its tests used in the US Presidential Emergency Plan for Aids Relief (PEPFAR) and the UN Global Fund initiatives.

“Beginning clinical trials for FDA approval marks a significant milestone for Chembio Diagnostics Inc and an important benchmark in HIV/AIDS testing technology,” says Lawrence Siebert, president of Chembio Diagnostics Inc. “Rapid testing will substantially and positively impact the fight to prevent the spread of HIV. The ability to quickly and accurately inform patients of their HIV status will enable infected patients to immediately begin treatment and substantially improve their quality of life.”

Contact: Chembio Diagnostics Inc (631) 924-1135

 Metabolon Selects ESA CoulArray Technology
In an effort to identify and monitor small molecule cellular biomarkers of disease and disease treatment, Metabolon Inc has adopted the CoulArray® technology from ESA Inc. The technology uses a series of highly efficient coulometric electrochemical cells to specifically monitor metabolically active small molecule cellular components.

The CoulArray system is used to simplify the inherent complexity of metabolomics samples by filtering mundane cellular components. The design and properties of the system facilitate easy data analysis of these types of often complex samples, and it offers the advantage of being able to distinguish minute changes in metabolomics patterns and components.

Contact: ESA Inc (978) 250-7000

Sizing Up Cost-Effective Enclosures for Medical Equipment

As medical equipment manufacturers develop more advanced and sensitive products, the demand for quality packaging and other protective enclosures becomes increasingly vital. Virtually all medical equipment, including microprocessor-controlled instruments, surgical systems, emergency-vehicle appliances, and lab apparatuses require protective enclosures.

Ed Sullivan from Zero Manufacturing has compiled a list of factors to consider when evaluating the most appropriate and cost-effective solution for protecting equipment.

• Seek objective design assistance. Many sensitive instruments require special engineering considerations when designing cases for transport, sterilization containers, or equipment covers.

• Customized does not mean expensive. While aluminum cases and cans have properties that are ideal for medical equipment, Sullivan recommends finding a manufacturer who offers both metal and plastic products. Offering both basic materials helps to avoid any prejudice pushing specifications one way or the other.

• Reserve a place for plastic. While off-the-shelf plastic cases are generally less expensive than their metal counterparts, high-tech plastics wear as well as metal and are suitable for sterilization, including high-temperature autoclave treatment.

• Consider low-volume capabilities. Applications for custom metal cases and cans often require low-volume production. Sullivan recommends doing business with suppliers who can handle these kinds of requirements with specialized manufacturing equipment.

• Don’t forget about cleaning and maintenance. Cleaning and maintenance of medical enclosures are significant contributors in the choice of both materials and suppliers. Cases and cans that are used in sterile environments, such as operating rooms, require easy and thorough cleaning.

Contact: Zero Manufacturing (801) 298-5900

Positive Results Found in the Study of Bladder Cancer

Two recent scientific advances in the area of bladder cancer have yielded positive results for both doctors and patients of the disease. Researchers have found that utilizing fluorescence in situ hybridization (FISH) technology when testing urine specimens for bladder cancer markers was 92% effective in detecting those markers, compared with a sensitivity of only 64% for traditional cytology screenings.

According to researchers, FISH technology works on voided urine by determining the absence or corruption of certain chromosomes in it, primarily numbers 7 and 9. Numerous scientific studies over the past decade have linked the deletion or corruption of these two chromosomes to a high likelihood of bladder cancer.

Additionally, scientists at the British Institute for Cancer Research identified E2F3, a gene being referred to as the missing link in the understanding of bladder cancer. Researchers at the institute have found a direct correlation between the overexpression of the gene and the proliferation of bladder cancer cells. The amount of E2F3 proteins present was a significant indicator of the seriousness of the cancer. Higher amounts were associated with larger tumors; smaller amounts indicated smaller, Stage I treatment and better prediction of disease progression in individual patients.

“FISH technology allows us to quickly and easily assess whether a biopsy is called for, and its accuracy provides invaluable peace of mind to the patient,” says George Hollenberg, MD, director of Acupath Laboratories Inc. “The prospect of new gene therapies on the horizon provides exciting options for physicians and hope for patients.”

According to Acupath Laboratories, bladder cancer is the ninth-most-common form of cancer, accounting for 330,000 new cases and 100,000 deaths each year. It is also one of the most chronic cancers, recurring in almost 70% of patients. Previous research identifying smoking as a chief cause of the disease has been corroborated in numerous medical journal reports over the past several years. The International Agency for Research on Cancer (IARC) estimates that 65% of male bladder cancer patients and 30% of female bladder cancer patients are smokers. Several other studies found that smokers are more than twice as likely to develop bladder cancer than nonsmokers, and the rate of which female smokers develop bladder cancer is significantly higher than the rate of male smokers.

“Clearly, bladder cancer is a disease that is troubling in its prevalence, yet the advances in our understanding of the disease bode well for patients and clinicians alike,” adds Hollenberg. “From our knowledge that quitting smoking can greatly decrease the chances of developing bladder cancer, to our ability to detect the disease earlier, easier, and more accurately than ever, to the prospect of new, effective gene-therapy treatments.”

Contact: Acupath Laboratories Inc
(516) 775-8103