Report Validating DNA Fingerprint Method Could Hasten Growth In Forensic Biotech

A recent document from the NRC is seen as a boost for entrepreneurs whose ventures center on the controversial technique A recently released National Research Council report on DNA fingerprinting not only puts the stamp of approval on the widely used technique, but also, according to one forensic scientist, should effectively mandate accreditation for labs preforming the test. And in the private sector, many in the business of providing DNA fingerprinting services and supplying reagents for DNA testing see the NRC imprimatur as an economic boon to an already growing industry. While most criminal courts have ruled that DNA fingerprinting is valid and have allowed it into evidence, some courts have barred this relatively new test on the grounds that prosecutors have not yet proved it is widely accepted in the scientific community. To that end, the FBI, National Science Foundation, National Institutes of Health, and other groups commissioned NRC in January 1990 to put together a committee of experts to assess DNA fingerprinting. The stamp of approval came on April 16 from NRC committee chairman Victor McKusick, a geneticist at Johns Hopkins University, who wrote in the report's preface: "DNA typing for personal identification is a powerful tool for criminal investigation and justice." But the committee report also strongly urged that laboratories wanting to submit their results to a court be accredited to do DNA fingerprinting and urged that national standards be put in place to safeguard the credibility of the results. The NRC report is the product of 27 months of effort by a 14-member committee composed of experts in law, forensic science, and molecular biology. The committee dealt with a number of contentious topics: the correct method for calculating the likelihood that a sample of blood, hair, or semen found at a crime scene matches a sample taken from a suspect; ensuring high-quality standards in the lab; and protecting the privacy of DNA databanks. Besides McKusick, the committee roster included such notables in the genetics field as Thomas Caskey at Baylor College of Medicine in Houston, Thomas Marr of Cold Spring Harbor Laboratory on Long Island, N.Y., and Eric Lander of MIT's Whitehead Institute in Cambridge, Mass. The FBI--which performs the majority of the DNA fingerprinting work and helped finance the report--is generally supportive of the NRC's findings. "It validates the use of DNA as a tool to be used in criminal courts," says spokeswoman Sharon Smith. However, there are specific points in the report that FBI assistant director John Hicks has problems with, and he will be issuing a formal response in mid-June, she says. Also on hold for now--awaiting Hicks's response--is action on the report's recommendation that the Department of Health and Human Services and the Department of Justice establish a joint federal committee to set national standards for DNA fingerprinting laboratories. In the meantime, the American Society of Crime Laboratory Directors (ASCLD) is already "taking the ball and running with it," according to forensic scientist Paul Ferrara, head of the state of Virginia's Forensic Science Division and a member of the NRC report committee. ASCLD had already added DNA fingerprinting to the roster of forensic techniques that it accredits, even before the report was issued. Ferrara, an ASCLD board member, says there will now be a lot of pressure for labs doing DNA analysis to become accredited because, according to the report, "Lack of accreditation should be considered to constitute a prima facie case that a laboratory has not complied with generally accepted standards." Certification Delays Getting all those labs certified may take several years, Ferrara says. At this point, only about one-third of all crime labs doing forensic analysis, whether of firearms, blood, or hair, are accredited by ASCLD, and there is "quite a waiting list of labs trying to get accredited," says Ferrara. Furthermore, the accreditation process usually takes about a year, even after laboratories move up the waiting list. In the interim, labs not certified by ASCLD will have to demonstrate to the courts that they are in compliance with the sample-analysis and quality-control procedures outlined in the report, he says. Lifecodes Corp., based in Stamford, Conn., is a supplier of DNA fingerprinting services and reagents. As a result of this report, "we think definitely there's going to be an expansion" in the company's reagent supply business, says Lifecodes president Walter Fredericks. He says his company currently has 60 percent of the market for DNA testing reagents, generating annual revenues of $3 million. With the expected expansion of forensic DNA fingerprinting, combined with the strong demand for paternity testing, Fredericks predicts that the total DNA reagent market should hit $40 million in the near future. Michael Hunkapiller, executive vice president of Applied Biosys-tems Inc. in Foster City, Calif., also anticipates that NRC's validation of DNA fingerprinting will give his business a boost. Applied Biosys-tems has developed a fluorescent tag method of labeling the DNA segments to be compared, which could replace the current method using radioactive labeling. The call for rigorous quality-control standards could make the company's product the method of choice because the crime scene sample can be labeled with a tag that fluoresces at one wavelength, with the suspect sample and control labeled at other wavelengths, Hunkapiller says. Then, the three can be mixed together for analysis, ensuring better reproducibility than would be obtained by keeping them separate. Hunkapiller is optimistic that this technique will be accepted by whatever national board ends up setting DNA fingerprinting standards. "The report was carefully crafted not to be so bold as to specify a particular protocol," he says. But Mark Stolorow, manager of forensic services at Cellmark Diagnositics in Germantown, Md., says the report's lack of specificity is its problem. "I think practitioners in the field were disappointed when they read the NRC report," he says, adding that the legal sections were out of date and scientific sections presented nothing new or original. "I would like to have seen a really solid set of guidelines." Stolorow contends that "after the initial excitement in the media is over, the report will end up having had little impact." And asking a cash-strapped Congress to fund a national DNA standards-setting board is "just not feasible." Stolorow says: "This [standards-setting] organization, unless they came together as volunteers, is not likely to be established in the next three or four years." So, forensic scientists will continue to muddle through the traditional evidentiary hearings that, although imperfect, have been effective in getting DNA fingerprinting introduced into most courts, he adds.

Report Validating DNA Fingerprint Method Could Hasten Growth In Forensic Biotech

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