Originally Published IVD Technology January/February 2005
INDUSTRY NEWS
Notables
The U.S. Department of Health and Human Services’ (HHS) Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children has voted that HHS adopt a new U.S. national standard expanding required testing for newborns. If accepted, the new HHS standard would require that newborns be screened for 30 genetic diseases. The committee’s recommendation was based on a report from the American College of Medical Genetics (ACMG; Bethesda, MD). ACMG assessed the value of testing for 84 genetic diseases before selecting 30 that would be most efficacious. The tests were selected because they detect diseases that are treatable, and ACMG believes that earlier treatment will translate into lower costs for the U.S. healthcare system. The 30 tests will cost an estimated $50 per set.
Currently, each state independently determines for which genetic diseases newborns must be tested. Most states require testing for 8 or fewer, but some test for as many as 36 disorders. This discrepancy is due, in part, to a lack of federal guidelines for which tests should be administered. The federal government now recommends testing for only phenylketonuria, congenital hypothyroidism, and sickle cell disease.
Although HHS has not yet announced whether it will adopt the committee’s recommendation, New York Governor George Pataki has decided to raise the state’s neonatal screening requirements from 11 to 44 tests. By spring 2005, newborns in New York will receive all 44 tests free of charge.
FDA has released a special-controls draft guidance to support the reclassification of new hepatitis A virus (HAV) serological assays from class III to class II. The document applies to diagnostic assays used to test for HAV-specific immunoglobulin M antibody, immunoglobulin G antibody, or total antibodies in human serum or plasma. The draft guidance can be accessed on-line at www.fda.gov/cdrh/ oivd/guidance/1536.html.
For manufacturers of sirolimus (rapamycin) test systems, the agency has issued a special-controls guidance document to support the classification of the test systems into class II. The performance characteristics and risks to health described in the guidance were heavily influenced by the work of representatives from clinical laboratories as well as device manufacturers who comprise the Therapeutic Drug Management Roundtable working group. The guidance can be accessed on-line at www.fda.gov/cdrh/oivd/guidance/1300.html.
In an effort to enhance FDA’s timely review of IVDs, the agency has published a guidance document to help third-party reviewers identify the key elements to consider when evaluating a premarket notification submission (510(k)). The guidance can be found on-line at www.fda.gov/cdrh/ode/guidance/2237.pdf.
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