IT WAS 1953 WHEN JAMES D.WATSON AND FRANCIS CRICK, working from X-ray data collected by Rosalind Franklin, described the double helix structure of the DNA molecule. That discovery inspired scientists to begin investigating the genetic basis of life.

In the 56 years since Watson and Crick published their findings, there has been steady progress at cracking open the human genome. One useful marker for this progress is the declining expenses required to sequence a base pair of DNA. In 1990, it cost $10 to sequence one base pair of DNA. Currently, Knome, Inc., says it will sell a whole genome sequence to anyone for $20,000. That represents a cost of $0.0003 per base pair of DNA.

But wait! That's not all... Complete Genomics, Inc., is selling a whole human genome for $20,000. That is a further reduction of 80% in the cost to sequence one base pair of DNA. (See pages 13-16.) These two examples demonstrate that both the cost and time required to sequence the entire human genome are rapidly falling to the goal of $1,000 and one hour.

I predict this will have a profound effect on laboratory medicine as we know it today. For the first time in human history, it will be economically feasible and scientifically possible to sequence the entire genome of individual humans. As many of you are aware, this is expected to revolutionize the prescription drug industry. It will also play a role in helping physicians make pre-symptomatic diagnoses for a variety of diseases.

But, it is the second application of cheap, fast, accurate gene sequencing that will be disruptive to pathology and laboratory testing as we know it today. Imagine the ability to use a lab-on-a-chip, operated within a handheld device, to do sophisticated molecular analysis of a patient's specimen, for pennies per gene, that produces highly sensitive results in minutes.

Tome, this is themore significant point about the race to the $1,000 whole human genome, sequenced in one hour or less. The same technologies which enable this achievement will be downsized and miniaturized for the express purpose of supporting sophisticated molecular assays to be performed in clinical laboratories, physicians' offices, point-of-care (POC) settings, and maybe even for patient self-test purposes. Although this will be disruptive to existing clinical and business models for pathology and clinical lab testing, it will also create tremendous new opportunities for the pathology profession.

Costs Falling Swiftly for Whole Genome Sequence

Complete Genomics says it is now selling $20,000 sequences to researchers and pharma

CEO SUMMARY: Several companies want to be first to achieve the holy grail in sequencing: an accurate whole human genome sequence produced in an hour for $1,000. Complete Genomics announced earlier this month that it could sequence the full human genome for a materials cost of $4,400 (not including labor and overhead). Another competitor, Illumina, is selling whole genome sequences for $48,000 to private individuals- and has customers!

Explaining Certification Versus Accreditation

ISO standards make it important for labs to understand the meaning of each term

CEO SUMMARY: Early signs are that the quality management systems (QMS) most likely to find favor with hospitals and clinical laboratories in the United States will be those that meet standards developed by the International Organization for Standardization (ISO. Many hospitals and clinical labs are considering adopting ISO 9001 or ISO 15189, respectively. As they do, it will be important to understand how the terms "accreditation," "certification," and "registration" are used in the application of standards published by ISO.

Geisinger's Use of EHR Creates Opportunity for Lab to Add Value

Integrated EHR allows clinicians to use lab test data to greater effect

CEO SUMMARY: Every health reform proposal makes it a high priority to implement a universal electronic medical record (EHR). Because lab test data is the essential component of a successful EHR, laboratory managers and pathologists may soon have a once-in-alifetime opportunity to use EHR implementation to boost the value to lab testing services. This is exactly what the laboratory at Geisinger Health has achieved in the 15 years since the system first implemented its integrated EHR solution.

Molecular Update: "Liked the Product-Bought the Company," BD Acquires HandyLab and Jaguar System

Health IT Update: Xerox, Dell, and Hewlett-Packard Each Buy Into IT Outsourcing Market

Growth opportunities are expected in outsourcing of information technology services to providers

INTELLIGENCE: Late & Latent

TRANSITIONS Aperio Technologies, Inc., of Vista, California,

MORE ON: Fraud The criminal complaint states that Adeyemi stole the identities of more than 150 of his coworkers.

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