Medical Device Link.

Originally Published IVD Technology September 2004

INDUSTRY NEWS

Despite pleas for an extension from IVD industry advocacy groups such as AdvaMed (Washington, DC) and the California Healthcare Institute (CHI; La Jolla, CA), the U.S. federal R&D tax credit expired on June 30. In its request to Congress for an extension and boost to the R&D credit AdvaMed referred to the rising cost of medical technology, saying, “[healthcare] R&D spending more than doubled during the 1990s and now stands at 11.4 percent of sales, four times the average for manufacturers overall.” The association also called for the permanent installation of the credit.

The credit was initially enacted in 1981 to stimulate R&D spending in the United States. It can be used only for R&D work performed in the country, with 75% of credit dollars going toward wages paid to people directly involved in R&D. The credit has been extended 10 times since its creation. 

Some companies facing rising R&D costs and the delay or possible loss of the tax credit have expressed that they may move their R&D investments abroad, which would result in the loss of many domestic high-wage jobs. More information about the R&D Credit for Qualified Research can be accessed on-line at www.irs.gov/businesses/small/industries/article/0,,id=97643,00.html.

 
Affymetrix Inc. (Santa Clara, CA), ParAllele BioScience (South San Francisco, CA), and Cambridge University (Cambridge, UK) have teamed up on a genetic study of type 1 diabetes. In this study, researchers from the Juvenile Diabetes Research Foundation/Wellcome Trust Diabetes and Inflammation Laboratory (DIL) at Cambridge will use Affymetrix’s GeneChip Tag arrays and ParAllele’s MegAllele genotyping reagents to study 10,000 nonsynonymous single nucleotide polymorphisms (SNPs that change the sequence of proteins). 

The researchers will compare the genotypes of 1000 control samples with those of 1000 disease samples. This comparison will serve as the first step in the analysis of over 20,000 DNA samples collected from diabetes patients and their relatives. DIL will share the samples and study results with other researchers, with the goal of developing better prognostic IVDs and therapies.

John Todd, who is leading the study at DIL, said, “We’ve been collecting samples for quite some time . . . This new solution for a genome-wide gene association provides us with the best opportunity we’ve ever had to discover new disease-associated genes and polymorphisms.”


Immunetics Inc. (Boston) received 510(k) clearance for its QuickELISA anthrax test. The test was developed under a CDC contract and is the first FDA-sanctioned test on the market designed to detect anthrax antibodies in patient blood samples. The test can generate results in less than an hour, which is a four-fold time reduction over CDC’s in-house protective antigen assay. The Immunetics test also outshined CDC’s test in both sensitivity and specificity. In clinical trials, Immunetics’ test detected 100% of anthrax-infected patients with 99% specificity, whereas CDC’s test performed with approximately 94% specificity.

The QuickELISA kits will be deployed in 150 CDC-designated Laboratory Response Network laboratories and will also be sold to the government for use by HHS, DoD, and DHS at a rate of $5 per kit.

The demand for rapid BSE tests will likely increase due to a change in the USDA’s testing policy. The agency’s Animal and Plant Health Inspection Service (APHIS; Washington, DC) will discontinue its policy of declaring BSE test results to be inconclusive on the basis of one rapid test. Now, USDA will conduct a second and third concurrent round of tests before a final assessment is made. A result will be considered inconclusive only if one or both of the follow-up tests produces inconclusive results.

Researchers at the University of Texas (Austin, TX) have developed a device that will allow practitioners in remote areas to quickly and inexpensively monitor AIDS patients and aid in their treatment. LabNow Inc. (Austin) has been created to manufacture and monitor the device, which uses microchip sensor technology to count CD4 lymphocytes, a type of white blood cell, in HIV-positive patients in 10 to 15 minutes. 

This test helps doctors to determine when to start treatment and how to tailor drug cocktails to each patient. Existing devices that perform the same test cost roughly $75,000 and are as large as refrigerators. The new unit is the size of a toaster. Its manufacturers hope to sell the device for $1000, with each test costing $5.

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