Government push could get AIDS test on market in six months.
If the research goes as well as company representatives were cautiously but optimistically predicting at this writing, clinical labs and blood banks around the country should have ready access to the kits by late this year.
"Given what we know about testing for this virus already, and the fact that this disease is a priority at the Department of Health-and Human Services, I believe the Government's goal of having a test ready in six months is realistic," said Thomas Lee, president, Biotech Reseach Laboratories, Rockville, Md. "We anticipate a great deal of cooperation from the Food and Drug Administration in moving this through" the approval process.
Biotech teamed with Du Pont in May to file for one of the licenses HHS announced it would award to develop blood test kits. Public Health Service scientists, headed by Dr. Robert Gallo of the National Cancer Institute, had announced in April that they had isolated HTLV-III, a retrovirus, as the likely cause of AIDS. The group also had developed ways to grow the virus, and secured patents, under the Public Health Service, for both serological detection of the virus and the method for continuous HTLV-III production.
Of the 25 companies that applied for the royalty-bearing licenses, HHS selected five after reviewing applications for just over a month--an unusually swift pace that underscored the department's desire to act against AIDS.
Besides Biotech/Du Pont, other licensees are: Abbott Laboratories, North Chicago, Ill.; Electro-Nucleonics, Columbia, Md.; Travenol-Genentech Diagnostics, Cambridge, Mass.; and Litton Bionetics, Kensington, Md.
The firms were selected on the basis of a lengthy list of criteria, including experience in working with retroviruses; ability to grow cells in culture for mass production; ability to package, market, and distribute kits in a national system "at a reasonable price"; and the capability of growing sufficient materials for large scale commercial use, i.e., "millions of assays per year."
The Government anticipates the commercial kits will become routinely used by blood banks, labs, hospitals, and physicians as an AIDS screen. It estimates some 23 million tests would be performed annually, with sales topping $100 million.
By late June, all five companies had received seed stock of the virus (about two liters) and had begun the job of scaling production to produce huge numbers of kits.
"The initial concern is assuring and monitoring the health of [our] workers due to this viru's insidious nature," said Norman Wald, Ph.D., of Abbott Diagnostics' Strategic Planning Group. "Then the technical hurdles are similar to those for putting together any assay to examine evidence of a viral infection. We need to grow sufficient amounts of the virus, we need to identify and purify the proper viral components to create an optimum test, and then we must produce enough assay kits to, first, validate the test through trials, and second, provide for widespread use."
Developing a prototype test, as the National Cancer Institute researchers have done, "is one thing, and making millions of them quite another," Wald noted.
The Government has defined the test as "biologic," which means work on the kits will be performed under an Investigational New Drug Application (IND) held by the National Cancer Institute or the company, and thus must flow through the FDA approval pipeline. Prior to commercial distribution, any kit needs an FDA-granted license.
According to FDA procedures, companies will have to submit study protocols with their IND applications. If the agency then gives the go-ahead, clinical trials may begin in onjunction with selected labs and blood banks. Once that data is collected, the agency and an outside advisory panel will review the findings. If the product is judged safe and effective, the agency will publish a notice of approval and full-scale marketing can get under way.
At this writing, some companies still were unsure how they would conduct their trials--the number of labs or blood banks they would work with, the number of units of blood they would attempt to sample, etc. However, a spokesman for Litton Bionetics said his company expected to build a data base from a minimum of 5,000 samples taken in 16 locations, four or five of which would be American Red Cross centers.
In fact, the Red Cross seemed likely at this writing to play a role in each of the companies' clinical trials, although that wasn't what the organization expected in mid-May when it had announced plans for a major AIDS-test study. "That was before the Government planned to have testing done under the licensure arrangement," noted Roger Dodd, Ph.D., head of transmissible diseases and immunology at the Red Cross.
The Red Cross had intended to study the economic and scientific feasibility of a routine blood test for the HTLV-III antibodies in collaboration with the National Cancer Institute researchers who isolated that virus and with Biotech, which was to produce the test. The three-way agreement called for initial testing of 40,000 units of blood at the chief Red Cross lab in Bethesda, Md., and also at a regional center. Blood bank personnel were to conduct the tests on the donated blood, marking the first time they would be performed by anyone but lab researchers.
HHS's decision has led the Red Cross "to step back a bit," Dodd said. "There has been no real change in our plans, but they have to be broader, and we can't move ahead as quickly as we hoped."
A major change is that "we expect now to be working with all the companies involved rather than just one," he said. Furthermore, the study may need to examine results of more than 40,000 units "as we look at different tests."
Despite setting back the Red Cross timetable and requiring a reworking of agreements with its partners, Dodd said the Government's decision to step into the testing picture was "most appropriate." He called the intent excellent--"to be sure that investigative activities proceed in an orderly fashion and are evaluated by as many scientists as possible."
The HTLV-III virus, of course, has not been conclusively proved to be the cause of AIDS. And the presence of antibodies to the retrovirus is not absolute proof that a person can transmit the disease or will develop it.
The evidenced has mounted convincingly, though. NCI's Dr. Gallo isolated the virus from more than 50 patients and had detected evidence of antibodies in about 85 per cent of those with AIDS and in about 80 per cent of patients with a condition he called pre-AIDS. His research paralleled findings over the last year at France's Pasteur Institute.
The lack of clear proof, however, will force ethical issues into the research picture as the studies move along. Anticipating this, the Red Cross has planned for an internal review board to consider the numerous questions the test kit will raise.
And use of an outside panel "is a distinct possibility," Dodd said. "This is an area of great concern and i wouldn't be surprised to see an interagency approach to develop recommendations." Moreover, he pointed out, these issues will necessarily be addressed in the protocols the testing companies submit with IND applications.
Among the troubling questions:
* Should a donor whose blood tests positive be informed? Some argue this would merely create undue fear and possibly even discrimination toward the donor. Others contend the patient deserves to know about possible infection and risks.
* If test results are routinely given, should people who are not donating be permitted to request the test as a check for AIDS?
* Should samples of units of blood already transfused be tested? And should those who received that blood be informed?
While those questions are yet to be resolved, the Federal licensees will press full steam ahead to develop the tests themselves. But short of conclusive proof of the HTLV-III/AIDS link, some might ask whether all this activity is justified now.
"The evidence that this is the causative agent is stronger than anything else we've seen so strong as to justify all the intense activity," Dodd said. "I'm confident this (virus) is it."
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|Publication:||Medical Laboratory Observer|
|Date:||Aug 1, 1984|
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