|Beckman Coulter Adds Electrophoresis Tutorial Program to E-Learning Library
Beckman Coulter Inc has added its Electrophoresis Tutor program to Lab Training Library, a collection of online courses designed to educate lab technologists about clinical conditions, medical procedures, and lab-testing protocol.
Previously available only on CD-ROM, the multimedia, comprehensive electrophoresis program educates clinical technologists, pathologists, and physicians on how to interpret protein electrophoresis patterns from serum, urine, and cerebrospinal fluid. The tutorial course also provides learning objectives, methodology descriptions of various sample types, and a review of assorted disease states.
The tutorial course, developed by the University of Washington, is for those who need to meet competency requirements, gain continuing education units, or benefit from basic electrophoresis training—all from the convenience of their personal computers.
The program is approved by the American Society for Clinical Laboratory Science (ASCLS) Professional Acknowledgment for Continuing Education (PACE) program. Users can receive three PACE units.
A Lab Training Library facility license is required to access Electrophoresis Tutor. A license starts at $400 for 40 users. An online tour of Lab Training Library is available at www.beckmancoulter.com/labtraininglibrary.
In addition to Lab Training Library, Beckman Coulter’s e-learning courses include a number of Webinars. The Webinars, many of which also qualify for PACE units, feature discussions on cardiac and tumor markers, drug testing, osteoporosis, diabetes management, hemostasis, cellular analysis, and more.
COLA Forms Alliance With American College of Physicians and Medical Laboratory Evaluation Proficiency Testing
COLA, a national health care accreditation organization, together with the American College of Physicians (ACP) and ACP’s Medical Laboratory Evaluation (MLE) proficiency testing service, have formed a cooperative alliance to help internists provide a turnkey solution to quality laboratory medical care that meets Clinical Laboratory Improvement Amendments (CLIA) requirements. CLIA, which passed in 1988, established federal standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of test results.
COLA will provide ACP and/or MLE members with a comprehensive service package that bundles laboratory accreditation, e-learning courses, and educational products with MLE’s proficiency testing. For physicians practicing internal medicine and operating laboratories, these integrated products and services provide an efficient means of meeting necessary accreditation requirements while enhancing professional knowledge using the latest industry developments. The MLE program will provide qualifying COLA and ACP members with a discount on initial enrollment in the MLE proficiency testing program.
“Through this partnership, we are able to deliver the best integrated package at a price that gives internists an economic and professional advantage,” says Douglas A. Beigel, CEO of COLA.
“Physicians are very often short on time, but they need to keep up to date with the latest developments in laboratory medicine,” says John Mitas, MD, FACP, deputy executive vice president and COO of the American College of Physicians. “The cooperative alliance enhances our ability to offer members the highest quality of resources available.”
SurgiLance Addresses Patent Dispute With Owen Mumford
|In response to an ongoing patent infringement case involving Owen Mumford Inc, SurgiLance Inc, a designer and manufacturer of medical safety devices, has issued a formal statement to its US customers. The statement addresses an Owen Mumford news release dated September 15, 2003, as well as the release of One-Step Plus, a new product from SurgiLance. The SurgiLance statement dated March 5, 2004 reads:
Dear SurgiLance Customers:
It has recently come to our attention that Owen Mumford Inc (OM) has continued to discuss its pending patent infringement case with our customers. While we would prefer to resolve our dispute with OM within the court system, we believe that it is important to set the record stra ight on several matters.
The Court’s Order dated September 2, 2003, referenced in OM’s press release dated September 15, 2003, did not prohibit SurgiLance from selling the One-Step product. While the Court has made several rulings in this case, to date no injunction requiring the cessation of sale has been issued. Thus, SurgiLance remains legally entitled to continue selling the current One-Step product.
SurgiLance strongly disagrees with the conclusions reached by the Court as to whether the One-Step violates the OM patent. SurgiLance is in the process of preparing an appeal in this case for submission to the Federal Circuit Court of Appeals, which handles the appeal of patent cases. We are confident that the Court of Appeals will overturn the rulings in this case.
The OM patent that is the subject of this dispute is held for a design that OM has never actually produced. It is a patent that exists on paper only and is nearing its expiration. SurgiLance believes that OM is using this paper patent to attempt to deprive valued customers like you from having access to better performing competitive products like the One-Step.
As evidence of our continued commitment to the evolution of quality safety products, we have recently announced the addition of the One-Step Plus line of safety lancets to our product line. The One-Step Plus product has not been involved in the Owen Mumford patent case, and is not the subject of any Court rulings. We are confident that the new One-Step Plus does not infringe the OM patent and we have obtained an opinion from patent counsel to that effect. We have also filed a new patent application for the One-Step Plus in order to legally protect our new design.
Despite this recent distraction, please be assured that we will continue to meet your lancet needs with the innovative safety products you have come to expect from us. As always, SurgiLance will continue to both aggressively support and respond to the needs of our customers in any and every way possible. We stand behind the quality, safety, and design of our product line with 100% confidence, and look forward to continuing to provide you with quality products in the years to come.
Thank you for your continued support.
Contact: SurgiLance Inc (770) 448-9493; www.surgilance.com
Parkinson’s Disease Foundation Takes Stance on Embryonic Stem Cell Development
The human cloning breakthrough made by scientists early last month at Seoul National University has divided the scientific community and rekindled a passionate, longtime debate between scientists and US lawmakers. Shortly after the embryonic cell research results were announced, the Parkinson’s Disease Foundation (PDF) released a statement fully supporting the process of deriving human embryonic stem cells from a cloned embryo.
“We are working to protect this line of medical inquiry,” says Lucy Sargent, PDF’s director of communications. “No one knows exactly what the research will or will not be able to do; however, scientists must be able to continue to research in order to understand its potential.”
Somatic cell nuclear transfer (SCNT), also known as therapeutic cloning, is considered the most viable solution to treating and eliminating diseases such as cancer, Alzheimer’s, diabetes, Parkinson’s, spinal cord injuries, heart disease, ALS, and other devastating conditions. Nearly 100 million Americans suffer from these diseases.
The US government adopted a law last year barring human cloning for reproduction, while research for therapeutic purposes is being cautiously accepted. All stem-cell research is subsidized by the government and is subject to ethical reviews.
The debate between scientists and lawmakers is centered on the confusion of how the cloning technology will be used. Organizations such as the PDF are in favor of therapeutic cloning, which is the transplanting of a patient’s DNA into an unfertilized egg in order to grow stem cells to cure diseases. Essentially, this technology allows patients to be cured by their own DNA. However, the government is concerned that SCNT technology will be used in the reproductive cloning of human beings, and has put forth efforts to restrict these types of research. According to the PDF, many patient advocacy groups, like the National Academy of Sciences, as well as a large percentage of the American public, agree with the government that human reproductive cloning should not be allowed. Yet the debate remains due to confusion regarding the scientific process of the research and the implications it has on moral issues.
“Unfortunately,” adds Sargent, “stem-cell research has turned into a tremendous bioethical debate, with the main question being, at what point does life start? Our job is to try and explain the process of stem-cell research, and inform the public about the procedure and uses of the technology so that it becomes less of a debate, and the research can advance.”
Contact: Parkinson’s Disease Foundation (800) 457-6676
|FDA Awards 510(k) Clearance to HIV-1 Genotyping System
Celera Diagnostics has been approved by the US Food and Drug Administration to expand claims related to the company’s ViroSeq HIV-1 Genotyping System, a molecular diagnostic test designed to detect mutations associated with drug resistance in HIV-1, the virus that causes AIDS.
The updated software algorithm analyzes information regarding known and newly identified mutations in HIV-1, 19 antiretroviral drugs, and reported drug resistance patterns. The ViroSeq system is used as an aid for monitoring and treating HIV infections. The system consists of an automated DNA sequencing instrument and reagents that are used to identify key strains of HIV-1. ViroSeq targets specific regions of the viral genome associated with drug resistant mutations.
“ViroSeq allows physicians to measure a patient’s response to a drug, and see if they are resistant to the types of virus that will have a negative, or even neutral effect with the treatments,” says Karen White, director of corporate communications for Celera Diagnostics.
Four drugs have been added to the updated software algorithm: tenofovir (Viread), emtricitabine (Emtriva), fosamprenavir (Lexiva), and atazanavir (Reyetaz).
According to Celera Diagnostics, in the decade since the introduction of antiretroviral drugs and diagnostic procedures, HIV genotyping, life expectancy, and quality of life have improved for HIV-infected patients.
Now that the system has been 510(k)-approved, ViroSeq will be marketed worldwide through an alliance with Abbott Laboratories.
Contact: Celera Diagnostics (510) 749-4200
AcroMetrix Acquires Exclusive Hepatitis and HIV Control Products
AcroMetrix Corp has performed an asset purchase with Nabi Biopharmaceutical for its ViroSure product line, one of only two FDA-approved quality control products for hepatitis and HIV.
“The ViroSure product line is complementary to our existing product offerings, which are primarily molecular quality controls,” says Michael Eck, president of AcroMetrix. “Acquiring the ViroSure line provides an avenue for us to expand to include products used in blood testing laboratories so that we can increase the offerings to the blood screening and clinical diagnostic markets.”
Contact: AcroMetrix (888) 746-7921
MRI Safety Device to be Marketed in US
The impact of ferromagnetic objects in a nonferromagnetic environment can be detrimental to equipment, and possibly fatal to patients. ETS-Lindgren, in collaboration with QinetiQ, has developed the Ferromagnetic Detection System, an alarm system that warns personnel before an object of significant ferrous metal is brought into an MRI room.
“This system was not developed to replace the procedures and precautionary measures taking place within these types of magnetic environments,” says Ben Turner, vice president of sales and marketing for ETS-Lindgren. “Our goal is to augment the current procedures by providing additional security.”
The Ferromagnetic Detection System is designed for hospitals, clinics, research labs, and MRI instrument manufacturing facilities. The system can be programmed to alert personnel in the event of a significant hazard. The system also allows harmless nonferromagnetic objects to pass, resulting in a reduction of false alarms, and does not interfere with electronic medical equipment.
“The Ferromagnetic Detection System has recently become available in the United States,” adds Turner. “Based on the success we’ve seen in the United Kingdom, where the equipment was first introduced, we are excited about its entrance into the US market.”
Contact: ETS-Lindgren (512) 531-6400
|Wyndgate Technologies Signs $1.2 Million Agreement With Prestigious Medical Center
City of Hope National Medical Center (Duarte, Calif) recently entered into a $1.2 million, 5-year joint venture with Wyndgate Technologies, a division of Global Med Technologies, for use of its Vein-to-Vein software. Under the terms of the agreement, City of Hope Medical Center will have legal rights of use for both the SafeTrace donor management and Safe Trace TX advanced transfusion management. The software is intended to aid in the organization’s cancer research while providing treatments to patients with life-threatening diseases.
The agreement between the two organizations establishes Wyndgate’s largest user of its Vein-to-Vein software in California.
Contact: Wyndgate Technologies (800) 996-3428