Medical Device Link.

Originally Published IVD Technology March 2003

INDUSTRY NEWS

AdvaMed is working toward the passage of legislation establishing a national fee schedule for clinical laboratory tests in the 108th Congress. The legislation describes a protocol for the Centers for Medicare and Medicaid Services (CMS) to follow when establishing fees for new technologies that are incorporated into Medicare’s outpatient laboratory payment system. It would also provide a mechanism for stakeholders to challenge fee schedule decisions.

Supporters of the legislation assert that a national fee schedule would generate more reliability and predictability for IVD reimbursement. 

An additional provision supported by AdvaMed would establish a CMS council to manage coverage coding and payment decisions for new technologies.

The Department of Energy’s Pacific Northwest National Laboratory (PNNL; Richland, WA) has developed a new antibody library that will accelerate the discovery of new detection tools. PNNL scientists have reconstituted components of the human immune system in brewer’s yeast, enabling the rapid identification of new antibodies. The technology could eventually make the need to produce antibodies within animals obsolete. 

To speed up the antibody identification process, PNNL used both high-throughput parallel magnetic cell sorting and high-resolution linear flow cytometric cell sorting to isolate antibodies. Dane Wittrup, PhD, Professor of Chemical and BioEngineering at the Massachusetts Institute of Technology, contributed to the development of the technology. According to Wittrup, the library “ is a complementary approach to analogous alternatives such as phage display and ribosome display, [and it] will open a door into antibody engineering for life sciences researchers currently using mouse hybridoma methods to make affinity reagents.”

The American Association of Clinical Chemistry (AACC; Washington, DC) has requested input from members of the IVD industry on topics for its 2004 Oak Ridge Conference. Promising diagnostics technologies in the early development stages are being sought, particularly those predicted to be available on the market in three to five years. Interested conference attendees should contact AACC directly at 202/835-8718 or sphillips@aacc.org.

The HANAA biodetection system uses polymerase chain reaction techniques to test four samples at once. Results are provided in less than 30 minutes.

IVD developers have a second opportunity to submit applications for National Institute of Allergy and Infectious Diseases (NIAID; Bethesda, MD) biodefense partnerships. Companies developing diagnostics that can be adapted to use as bioterror agent detection tools may submit applications as late as June 10, 2003. 

NIAID’s program is recruiting agencies for assistance in developing diagnostics in the target identification, preclinical, and clinical stages of research and development. To qualify for the program, applicants must demonstrate a proven technical approach in one of NIH’s high-priority areas. The proposed diagnostics must be methods of detecting NIAID Categories A–C priority agents. 
Among Category A agents are anthrax, plague, smallpox, tularemia, and ebola. Category B agents include ricin toxin, typhus fever, salmonella, and West Nile virus. Lastly, Category C agents are those that pose emergency infectious disease threats such as yellow fever, influenza, and rabies.

Applicable tests for these agents include both high-throughput antigen screens containing microbial signature profiles and novel immune assays to study human immune responses. In its annual report, FDA’s Office of Device Evaluation recently provided guidance on the development of diagnostics used to identify bioterror agents. 

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