Originally Published IVD Technology
May 2003
INDUSTRY NEWS
Notables |
An international consortium of scientists that includes the National Human Genome Research Institute and the International Human Genome Sequencing
Consortium, among others, announced that it has completed the map of the human genome to an accuracy of 99.99%. In 2000, the group announced that they had identified about 97% of the base pairs and completed a rough draft of the code, but the sequence is now finalized and can be accessed from public databases.
The project began in 1990 and was expected to last 15 years and cost $3 billion, however it has been completed in less than 13 years at a cost of $2.7 billion. The project was completed 50 years, to the month, after scientists Francis Crick and James Watson published their discovery of the structure of DNA.
Several projects are under way to facilitate the use of this genetic map. The International Haplotype Map Project (IHMP) is a three-year project that began last fall. Collaborators on the project will attempt to pinpoint areas of genetic variation within the genome. Identification of these areas should expedite the location of targets for developing medical diagnostics and treatments. More information on the IHMP can be found on the Internet at
http://hapmap.cshl.org.
The Center for Devices and Radiological Health (CDRH) will add criteria defining devices of use for “urgent military needs” to new guidance on expediting premarket approval (PMA) applications. PMA applicants will be allowed to request expedited review when they obtain the endorsement of the military or the Department of Homeland Security.
Focus Technologies (Cypress, CA) has released laboratory reagents for detecting Flavivirus (West Nile Virus) IgM and IgG antibodies, using a recombinant protein antigen licensed from the Centers for Disease Control and Prevention (CDC).
Two analyte-specific reagent (ASR) package configurations will be available. The first ASR will be an Antigen Pack available exclusively to public health laboratories as a replacement for antigen previously supplied by CDC. The second will be IgG and IgM Reagent Packs sold to public health facilities, commercial laboratories, and hospitals.
The company will submit a 510(k) application to FDA for Flavivirus ELISA diagnostic kits in summer 2003, once the data from formal clinical trails is available.
Results of a study at the Vanderbilt University Medical Center (Nashville, TN) indicate that patients with the common Factor V Leiden genetic variation who undergo cardiac surgery lose less blood and require fewer transfusions. This finding may lead to the establishment of genetic screening for the blood clotting–linked Factor V Leiden as a routine test for heart surgery patients.
Factor V is an essential protein for normal blood clotting. The Leiden variant of the gene that encodes this protein is one of the most common inherited blood coagulation mutations. Although patients with this mutation are at a heightened risk of forming blood clots, they are more protected against blood loss, and therefore less prone to receiving transfusions after heart surgery. Study results are published in the February 25, 2003, issue of Circulation.
New legislation proposes to extend the scope of Medicare coverage for diagnostic testing. The Medicare Cholesterol Screening Coverage Act of 2003 was introduced in the Senate by Senators Byron Dorgan (D–ND), Ben Nighthorse Campbell (R–CO), and Jeff Bingaman (D–NM), and in the House by Representatives Dave Camp (R–MI) and William Jefferson (D–LA). If passed, the legislation will guarantee Medicare coverage for tests used for preventive screenings for cholesterol, other lipid levels, and for certain cardiovascular diseases.
A second act, titled the Access to Diabetes Screening Services Act of 2003 was introduced by Senators Blanche Lincoln (D–AR), Susan Collins (R–ME), and Jeff Bingaman. This act will allow Medicare to cover laboratory diagnostic tests used to screen for diabetes. Currently, Medicare is prohibited from providing reimbursement for these services by federal law.
The Center for Devices and Radiological Health (CDRH) has released draft guidance for the submission of premarket notification (510(k)) and premarket approval (PMA) applications for IVDs. The document makes recommendations for using sound scientific and statistically valid analyses to evaluate new diagnostic devices. It discusses appropriate data collection, analysis, and resolution of discrepant results to support indications for the use of IVDs when a new device is compared to a recognized device or reference method, or examined via methods not commonly used.
The guidance states that discrepant resolution is not a sufficient means by which to calculate the value of a new diagnostic test in comparison with an imperfect standard. When test results disagree, the guidance recommends that manufacturers use an additional, perfect standard to generate an unbiased result. It also identifies common inappropriate practices. Copies of the guidance are available from the Internet at
http://www.fda.gov/cdrh/osb/guidance/1428.pdf.
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