COLA co-sponsors upcoming bioterrorism audioconference
In the wake of recent terrorist attacks, COLA, a national accreditation organization, is sponsoring an audioconference entitled, “What Every Laboratory Needs to Know about Chemical and Bio Terrorism.” The audioconference will take place on Wednesday, Dec. 12, 2001 from 1:00 to 3:00 p.m. E.S.T.

Experts in chemical and bio terrorism will review the vital role that the clinical laboratory plays and what a comprehensive disaster plan should entail. Valuable resources will be shared that will help participants evaluate and improve their plans.

Participants will learn the following: the role of the clinical laboratory in the event of an attack; what a disaster plan should look like; how to evaluate and ensure that plan will work; what biological and chemical agents may be used; how to prepare to support local public health laboratories; what resources are available to help define and test a disaster plan.

The program is approved by the AACC for 2 Accent category 1 credits. All profits from the conference will be donated to the Salvation Army Disaster Services. Along with COLA, the conference is sponsored by the American Association of Clinical Chemistry, the American Association of Physician Office Laboratories, the American Clinical Laboratory Association, the Association of Public Health Laboratories, the American Proficiency Institute, the American Society of Clinical Laboratory Science, the American Society for Microbiology, the College of American Pathologists, the Center for Disease Control and The Endocrine Society.

There is one registration fee ($225) per site. Interested participants may call 800-892-1400 to request a faxed registration form or register directly online at www.aacc.org.

MarketLab named one of America’s fastest growing private companies by Inc 500
Kentwood, Michigan-based MarketLab is one of America’s entrepreneurial growth leaders, according to the Inc 500, Inc’s annual ranking of the nation’s fastest-growing private companies.

photoMarketLab founder, Michael Bieker (second from left), and employees at the 2001 CLMA meeting in St. Louis.

The Inc 500 ranks the nation’s leading entrepreneurial firms according to sales growth over the previous five years. Former Inc 500 companies that have gone on to become household names include Microsoft, Timberland, Domino’s Pizza and Patagonia. “The Inc 500 gives America a window on the future — which companies will be the Microsoft and Timberlands of tomorrow,“ said George Gendron, Inc editor-in-chief. “The economy may have slowed, but entrepreneurial enterprises have always been, and will continue to be, the nation’s foremost engine of growth and job creation.”

MarketLab, a business-to-business, direct-mail cataloger of specialty products for hospital and research laboratories, ranks 276th on the Inc 500 list, in recognition of its 1078 percent growth rate over the past five years — sales have grown from $300,000 in 1996 to $3,300,000 in 2000.

MarketLab was founded as Phlebotic, Inc. in 1994, by Michael Bieker, who established the company in his basement to manufacture and sell a device he invented to hold blood collection tubes during the blood draw procedure. In 1996, Bieker changed the company’s name to MarketLab and the company’s focus from manufacturing to direct mail cataloging.

“It is exciting and gratifying to be included in Inc magazine’s prestigious ranking,” said Bieker. “I am so proud of the people who make up this company; it has been through their ideas and hard work that we have been able to achieve such tremendous growth.”

To be eligible for this year’s Inc 500, companies had to be independent and privately held through 2000, have generated at least $200,000 in sales in 1996 (the base year), and show that sales in 2000 exceeded 1999 sales figures.

Founded in 1979, Boston-based Inc was acquired last year by G+J USA, one of America’s largest magazine publishers and is part of the company’s newly-formed Business Innovator Group. G+J USA also publishes Fast Company, Rosie, Child, Family Circle, Fitness, Homestyle, Parents and YM. The company is 25.1 percent owned by Bertelsmann AG, the largest privately held and the fifth largest media company in the world with yearly revenues of $16 billion.
Roche & Mayo collaborate on rapid anthrax test for the U.S.
Roche Diagnostics will make a DNA test that has been developed by the Mayo Clinic to rapidly identify anthrax in human and environmental samples. The new test can identify anthrax in less than one hour instead of days. Tests will be offered initially to laboratories at no charge.

The test will give laboratories the ability to perform rapid DNA testing, eliminating the waiting period currently required at most laboratories to identify anthrax.

"This rapid identification will enable doctors to begin more timely treatment of patients who have been exposed to anthrax, and it will more quickly alleviate undue anxiety for people who haven’t been exposed," said Franklin R. Cockerill III, M.D., the Mayo Clinic microbiologist who led the development team. Cockerill developed the test using Roche’s LightCycler instrument for PCR-based assays. To make the test widely available, Roche accelerated production of the reagents needed to run the assay on the LightCycler.

“The very quick development of this test shows our strength and ability to shape industry standards and is a successful outcome of the excellent co-operation between Roche and the Mayo Clinic,” said Heino von Prondzynski, Head of Roche’s Diagnostics Division and member of the Executive Committee.

About two dozen geographically dispersed LightCycler-equipped laboratories in the United States started conducting the test in November. Mayo has been working with the federal government to make the test available to any federal agency and is lending its expertise to state and federal health officials in the wake of the reported cases of anthrax exposure.

Greiner Bio-One MiniCollect tubes used by ABX Diagnostics
Greiner Bio-One Vacuette North America has announced the development of a strategic marketing relationship with ABX Diagnostics. Vacuette Mini-Collect tubes have been accepted by ABX as the tube of choice for hematology testing on their Micros and Penta instruments.

Due to their design, Greiner Bio-One’s MiniCollect tubes allow for the collection of low-volume blood samples and safe sampling from the tube by the ABX instruments. The MiniCollect tube can be sampled directly through the cap, providing a completely closed system.

Dave Weindl, ABX Diagnostic Product Integration and Applications Manager said, “We have tested all the blood collection tubes on the market and nothing works better than the Greiner MiniCollect tube. The MiniCollect cap works well with our instruments’ cap piercing unit and allows the blood sample to stay completely contained during testing.”
AdvaMed announces steps to speed availability of technologies to combat bioterrorism
AdvaMed, on behalf of its Medical Technology Preparedness Council, recently submitted written testimony to the House Energy & Commerce Committee hearing regarding medical technology’s role in preparing America for bioterrorism.

The Council, which was formed in response to the Sept. 11 attacks, seeks to ensure that new medical technologies to fight bioterrorism are developed and made available to the public quickly. The testimony outlines the Council’s new Bioterrorism Detection and Response Initiative, which was developed following discussions with HHS Secretary Tommy Thompson, FDA officials and other government officials.

“The federal government has made clear to us that it needs better medical technologies to detect and prevent diseases caused by bioterrorism,” said AdvaMed President Pamela G. Bailey. “Important technologies are available now to help fight bioterrorism. Many more are under development and must be brought to the public as quickly as possible.”

New technologies are being developed that can help detect, prevent and treat diseases caused by bioterrorism. These include rapid anthrax diagnostics and novel vaccine delivery technologies.

Existing technologies, such as rapid flu tests, could play an important role in fighting the anthrax scare in the coming months. Manufacturers are expanding production of the tests and at least one is giving them for free to public health labs.

In its testimony, the Council praised the FDA for its ongoing, collaborative effort to make effective use of its expedited review program to ensure that new, rapid tests for anthrax and other bioterrorism agents are approved as quickly as possible. The Council is calling for:

A collaborative expedited review policy for medical technologies that help fight bioterrorism. This would expand the agency’s ongoing collaboration with the Preparedness Council to establish a priority review track for new anthrax tests.

Clear review paths for novel bioterrorism countermeasures: Many technologies such as novel vaccine delivery technologies are combination products that incorporate devices and drugs or biologics. These face added delays because they must go through two FDA offices for premarket review. FDA should establish a separate office to ensure clear review paths and timely action on these technologies.