HUM-MOLGEN archive: ETHI, DIAG: Laboratory standards

1) X-Sender: olam@ulrik.uio.no 1 - In Norway we have a new law on medical applications of biotechnology, where there is opportunity to regulate artificial fertilization, preimplantation diagnostics, pre- and postnatal genetic testing and gene therapy. We are currently discussing the criteria for allowing a lab to do genetic tests, and for allowing specific tests. One may require the lab to be accredited, by which their way of performing specific procedures is quality controlled by an external body. By this procedure they have to do tests in a specific way over long periods. An alternative, perhaps better suited for research labs and quickly developing procedures, one may require the lab to get a GLP (Good lab. practise) certificate. In both cases an external body will irregularly visit the lab, check the records and the way work is done. What is the experience in other countries, have quality controls been enforced in this way anywhere? I think some Dutch and British labs have been certified. It would be interesting to hear from these (or be pointed towards them). Ola Ola Myklebost, Dr Philos Email (org): ola.myklebost@labmed.uio.no Dept of Tumor Biology or (machine address): olam@radium.uio.no Institute for Cancer Research Tel Office/lab: +47-2293-4299 (-5422) The Norwegian Radium Hospital Switchboard: +47-2293-4000 Montebello Fax: +47-2252-2421 N-0310 OSLO, Norway Cellular phone: +47-9008-7139 Private: +47-6680-2905 ____________________________________________________________________________ 2) Editors note: This reply briefly summarizes what is happening in the United States. The issues raised are complex and urgent as commercial genetic testing is spreading worldwide. In the U.S. an NIH/ELSI task force headed by Dr. Neil Holtzman of Johns Hopkins is studying all of these issues. HUM-MOLGEN expects to have a copy of the report of the first meeting of the task force available shortly. Among the problems identified are the current inability or unwillingness of either the FDA or HCFA (Health Care Financing Addministration) to: 1) apply existing regulations prohibiting the use of products approved for research use in clinical situations 2) regulate the use of "Home Brews" 3) regulate "off-label" use of products approved for one purpose, i.e. confirmation of diagnosis, but used for another purpose, i.e. predictive testing 4) establish standards for the accuracy and predictive value of these tests. This is obviously a difficult problem, because the conditions predicted by many tests do not become manifest for many years. The Task Force is also going to investigate the process for licensing of laboratories. This problem was thought to have been solved in this country several years ago by the enactment of a Federal law (CLIA). However, the regulations enacted under CLIA do not apply directly to most genetic testing. The Task Force is investigating the question of which bodies (States, professional organizations such as The American College of Medical Genetics, etcetera) should be entrusted with the authority to accredit laboratories doing genetic tests. The Task Force is also considering the issues of informed consent and counseling in connection with genetic testing. Two of the relevant paragraphs concerning these issues, some of which we have recently discussed in this newsgroup are set forth below. "A common theme was that interpretation of test results and counseling about their implications are integral parts of the test itself. Great care must be taken in offering tests and communicating test results, especially when thre is no intervention of proven efficacy for an identified genetic condition and little or no data on the impact of test results on people being tested. Furthermore, the predictive value of these tests can vary greatly and must be taken into account. Some interpretative services might be provided by laboratories, but may prove costly, intrude on the practice of medicine, and raise liability issues. The Task Force will consider the extent of manufacturer and laboratory responsibility in assuring appropriate test education and past-test interpretation. Given the increasing likelihood that primary care providers will be ordering genetic tests to aid in preventive care, their education in the essentials of this technology is important. Task Force members differed over the extent to which primary caregivers could master the subject. Even if sufficiently educated in genetics, the traditional directiveness of primary care providers in advising patients may be less desirable than the relative impartiality of genetic counselors. Nevertheless, some patients may expect and desire direction in this area. Genetic counselors could assume the responsibility of properly interpreting test results, but there is a shortage of counselors and training programs. For some tests, such as Tay-Sachs, providers are less involved; results are often sent to patients directly."