Originally Published IVD Technology November/December 2003
INDUSTRY NEWS
Genetic testing proponents see promising developments
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With a unanimous vote, the U.S. Senate approved legislation that would provide protection against discrimination by employers and health insurers on the basis of an individual's genetic information. Senate passage of the Genetic Information Nondiscrimination Act of 2003 (S.1053) in October may well be viewed as ground gained along the path to publicwide adoption of genetic testing.
If the bill also receives approval from the U.S. House of Representatives, it will serve as the first comprehensive set of federal protections from workplace and insurance coverage bias due to genetic testing. In an effort to ensure that genetic testing will confer health benefits without exposing people to discrimination in the workplace or medical arena, the legislation covers such areas as confidentiality, nondiscrimination, and civil rights. The legislation also requires the establishment of a Genetic Nondiscrimination Study Commission to keep Congress up to date on advances in the field of genetics.
The protection afforded by passage of this bill will likely relieve many concerns of individuals interested in pursuing genetic testing, but hesitant to take advantage of available tests. This is good news for manufacturers of molecular diagnostics.
"By preventing discrimination, this bill eradicates the fear that could keep millions of Americans . . . from seeking out information that could potentially save lives," stated U.S. Senator Olympia J. Snowe (R–ME), the original sponsor of the bill in the Senate. According to Snowe, nearly 32% of women offered a genetic test for breast cancer risk by the National Institutes of Health declined to take it, citing discrimination by health insurers as a concern.
In regard to discrimination by medical insurance companies, the bill prohibits enrollment discrimination based on information related to genetic tests taken by individuals or their family members, premium discrimination based on information pertaining to genetic tests taken by individuals or their family members, and the requiring of individuals to receive genetic testing. Citing provisions of the Health Insurance Portability and Accountability Act of 1996 as providing adequate protection for those receiving genetic testing, Donald Young, MD, president of the Health Insurance Association of America (Washington, DC), responded unfavorably to the Senate's passage of the bill. "Although this [nondiscrimination] legislation is well-intended . . . health insurers continue to believe it will only add unnecessary and costly burdens without improving consumer protection," said Young.
Despite the negative response from the insurance association, the bill is now awaiting a likely approval by the House. Representative Louise M. Slaughter (D–NY), the lead sponsor of the genetic nondiscrimination legislation in the House, has called for immediate passage of the bill by the House. "The Senate has done its duty; now it's the House's turn. Genetic discrimination is an insidious threat to privacy, public health, and medical research. We must act now to ensure that scientists and patients will be able to use genetic information to its fullest extent, without fear," she said.
As concerning employment discrimination, the bill prohibits the collection of genetic information except when health or genetic services are offered by an employer, an employer needs information to comply with provisions of family and medical leave laws, an employer purchases publicly and commercially available documents containing family medical history, or when necessary to monitor the effects of toxic substances in the workplace (with receipt of employee authorization or as required by law).
A second fundamental advance for manufacturers of molecular diagnostics is one that will impact research and development of the tests. This tool has been supplied courtesy of Affymetrix (Santa Clara, CA), which has made commercially available a single chip incorporating fragments of each of the 35,000 known genes that make up the human genome.
The GeneChip brand Human Genome (HG) U133 Plus 2.0 Array will provide researchers with comprehensive and up-to-date genomewide gene expression analysis. The array combines the content of the previous HG-U133 two-array set with 10,000 new probe sets representing about 6500 new genes. The array uses 22 independent measures to detect the hybridization of each transcript on the array and 1.3 million data points, which the company claims to be more than 30 times that of any other array technology.
Both Agilent Technologies (Palo Alto, CA) and Applied Biosystems (Foster City, CA) are also developing versions of whole-genome microarrays. The two companies are completing field tests of their chips and plan to release their arrays by the end of 2003. Although the new chips will provide effective tools for research, it may be a while before they lead to the development of commercially viable tests.
"The new chip from Affymetrix (and those that will shortly follow from its competitors) will provide researchers with a more powerful tool to study gene expression. I don't believe it will have much impact on molecular diagnostics for the forseeable future.
Firstly, the use of this type of device in diagnostics requires identification of thousands of useful markers with demonstrated diagnostic value. These markers do not currently exist, and even those that are under investigation would not require an array with more than hundreds of markers.
Secondly, there are substantial technical, quality assurance, and regulatory issues that must be addressed before such a device could be sold for routine diagnostic use," noted Richard Schifreen, PhD, director of technology and market development at Promega Corp. (Madison, WI).
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