Medical Device Link.

IVD Technology Magazine
IVDT Article Index

Originally Published July 2000

EDITOR'S PAGE

Second heat . . .

In case you've been hiding from all sources of news, here's a flash from the molecular front: the race to sequence the estimated 3.5 billion base pairs that make up the human genome is officially over. But race lovers take heart; sometimes the end of one race is merely a signal for the next one to begin.

Announcement of the achievement was made in June, amid much ballyhoo, by Craig Venter, CEO of Celera Genomics (Rockville, MD), and Francis Collins, director of the Human Genome Research Institute at the National Institutes of Health (Bethesda, MD). Considering the well-publicized animosity that had developed between Celera's private sequencers and researchers of the international Human Genome Project (HGP), observers might be forgiven for viewing the announcement as though it were something akin to a cease-fire declaration.

The joint announcement acknowledged the role of both public and private researchers in completing the genome sequencing project. But beyond this show of scientific fraternité, other aspects of the announcement needed a little more explanation. Official completion, for instance, turned out to mean that the human genome has been 97% sequenced in rough draft form, leaving years of work to produce the final and validated version. And the fact that the announcement was made jointly in no way indicated that public and private researchers were tied when the race was called off; by all accounts, the race ended with Venter's Celera well in the lead.

For some, it is a telling fact that private industry was able to accomplish in a short time what government researchers struggled to do for more than a decade. If private industry can truly outpace and outperform an international effort such as the HGP, they reason, there is little need for government to remain a major player in the development of genetic technologies. But the logic of this argument seems wrong-headed, to say the least. Government efforts brought together the funding and human resources necessary to make the HGP a reality, and without the successes of the HGP it is doubtful whether private industry would ever have been prepared to speed the genetic baton across the finish line.

Governments can and should continue to play significant roles in forwarding the opening of the biotechnology era. Government agencies are better positioned than private companies to resolve the thorny issues involved in the patenting of genetic sequences while ensuring that all stakeholders (including IVD manufacturers) are accommodated. With regard to the ethical use of genetic testing, governments are well equipped to develop guidelines, fund training, and provide enforcement among those who will be handling genetic information. And government laboratories can bring resources to bear against difficult research issues, thereby ensuring that progress in the field does not stall for lack of a decent return on investment.

For IVD manufacturers, the implications of these developments in the world of biotechnology are less remote than they may seem. Completion of the sequencing race means that the race to develop and commercialize genetic-based products is about to begin in earnest. Observers expect that many such products will be diagnostics, and many others will rely on the existence of diagnostics. This new race will likely involve more companies and more-intense competition than ever before. To make the most of their opportunities in this field, IVD companies should be ready to race now.

Steven Halasey
steve.halasey@cancom.com