CEO SUMMARY: Five years ago, the only option for mapping was to involve the government. New advancements in technology have lowered costs so radically that now private companies are willing to use their own funds to map the human genome. This brings the day ever closer when genetics-based diagnostic tests replace existing phenotypic-based diagnostics. Advances in genetics will also transform anatomic pathology.
MOST LABORATORY EXECUTIVES are unaware of a revolutionary development in the field of genetics. On May 11, instrument maker Perkin-Elmer Corp. announced a joint venture with J. Craig Venter, Ph.D. and Dr. Venter’s Institute for Genomic Research.
The specific goal of the joint venture is to map the human genome on an accelerated basis. Using a new generation of technology, the joint venture expects to map the entire human gene sequence in as little as three to four years, at a cost of less than $300 million.
In contrast, the federal government’s Human Genome project is a 15-year effort that was launched in 1990. Run by the the National Institute of Health (NIH) and the Department of Energy, it is budgeted at $3 billion. Currently the project is at the halfway point. It was scheduled to have 1% of the human genome sequenced, but is ahead of schedule with about 3% of the genes completely mapped.
Should the effort by Perkin-Elmer and Dr. Venter prove successful, the ramifications are significant. For example, a tidal wave of new diagnostic tests could hit the the clinical laboratory marketplace within the next seven years.
Based on new knowledge of human genetics, these tests could substantially change the existing mix of diagnostic tests currently in clinical use. Such new genetics-based assays would inevitably impact the economics and finances of clinical laboratories. Their introduction could create a new class of winners and losers in the clinical lab industry, affect-ing hospital laboratories and commercial laboratories alike.
For the healthcare industry, a successful effort by Perkin-Elmer and Dr. Venter brings a host of concerns. First, if private industry pays for this research, would Congress reduce existing appropriations now funding the Human Genome Project?
Second, if a private company gains this knowledge, how will society resolve issues affecting patent rights, legitimate access to the knowledge by researchers, and patient privacy. There is little consensus on these issues today.
New Genetic Analyzers
This venture should interest laboratory executives for another reason. It is only feasible because of Perkin-Elmer’s new generation of genetic analyzers. These machines cost $300,000 and will be available to the commercial market within six to eight months. In only 15 minutes of operator-assisted time, the machine can process 15,000 samples per day. The previous generation of instruments required eight hours of operator time for the same number of samples.
Michael Hunkapiller, President of the Applied Biosystems Division of Perkin-Elmer, states that these new machines are so fast that they could identify the human genes 10 times more cheaply than the National Institute of Health’s estimates. In fact, the joint venture believes that it will take as little as $150 million to $200 million to accomplish this goal. Perkin-Elmer is providing most of the funding for the joint venture.
Rapid Scientific Advances
THE DARK REPORT considers this story to be of importance for two reasons. First, it demonstrates how rapidly genetic science is advancing. In just eight years, technology has compressed a $3 billion dollar project requiring 15 years into one which requires one-tenth the money and one-third the time.
Second, it is vital that laboratory directors and pathologists understand that new genetics-knowledge will revolutionize both diagnostics and therapeutics. Speaking bluntly, the coming tidal wave of genetics-based discoveries will upend clinical laboratory science and anatomic pathology as we know it today.
Seen from the level of technology in 1990, the joint venture between Perkin- Elmer and Dr. Venter is nothing short of revolutionary. Because the introduction of new technology tends to be exponential in its impact over time, lab executives and pathologists should begin to pay close attention to developments in the field of genetics.
Those laboratories and pathology practices which flourish in the year 2005 will be the ones which were early implementers of emerging genetics-based diagnostics. The warning signs are clear for all who pay heed.
Dr. Venter Responsible For First Complete “Map”
J. Craig Venter, Ph.D. is the founder of the Institute of Genetic Research. He made news in 1995 when he became the first to map an entire genome for a living system: the meningitis bacterium.
Since then, Dr. Ventor and his team have identified genetic sequences for microbes that cause Lyme disease, syphilis, and stomach ulcers. His partnership with Perkin-Elmer to map the entire human genome is controversial. Some critics are convinced that the joint venture will not be able to pull it off.
But some observers believe differently. “It’s not impossible at all that he could succeed,” observed Dr. William Haseltine, CEO of Human Genome Sciences in Rockville, Maryland. “Dr. Venter has demonstrated a fine track record of innovation and organization.”