| R. Lewis Dark:
Genome Sequencing Promises to be Disruptive
EVERYONE SHOULD CAREFULLY READ OUR LEAD STORY ON THE FACING PAGE. Titled
"Rapid Gene Sequencing Predicted by Mid-2009," it is a revealing look at the
declaration of California-based Complete Genetics that, in less than eight
months, it will begin delivering full human genome sequences priced at
$5,000 each to interested customers at a cost of only $1,000 to itself!
Complete Genomics' announcement represents the same paradigmshifting
earthquake in genetic medicine that occurred back on May 11, 1998.
That's the day when J. Craig Venter, Ph.D., and his partner, Perkin-Elmer, announced their plans to map the entire human genome for a cost under $300 million and do it in within three to four years. At the time, the Human Genome Project was about halfway through a 15-year, $3 billion project to complete the first full sequence of the human genome.
THE DARK REPORT predicted that Venter's effort would succeed and, as it
did, it would accelerate both the accumulation of genetic knowledge and the
speed with which it was converted into clinically useful molecular diagnostic
tests. We wrote: "Those laboratories and pathology practices which flourish
in the year 2005 will be the ones which were early implementers of
emerging genetics-based diagnostics." (See TDR, June 15, 1998.)
Venter achieved his bold goal in just 25 months. It was June 25, 2000,
when President Bill Clinton publicly announced the successful sequencing
of the human genome and recognized the roles of both Venter and Frances
S. Collins, M.D., Ph.D., who had led the Human Genome Consortium, in
this accomplishment. For the lab industry, by 2005, a host of new lab companies
had emerged to offer a growing menu of molecular tests. Molecular
assays for infectious diseases and certain cancers were transforming clinical
practices, giving truth to THE DARK REPORT's 1998 prophesy.
Now THE DARK REPORT sees a parallel moment of disruption in genetic
medicine. Complete Genomics and a host of competitors are about to transform
human genome sequencing, dropping price and speed while opening the
doors to vast amounts of new knowledge about DNA, RNA, and the human
proteome. Pathologists and lab directors should prepare for an accelerating
flood of new insights about genes and proteins. Many of these discoveries will
rapidly lead to new laboratory tests that offer physicians and patientsmore precise
tools for diagnosis, therapeutic decisions, and patient monitoring.
Rapid Genome Sequencing
Predicted by Mid-2009
Surprise announcement that California firm is
about to achieve a $1,000 human genome sequence
CEO SUMMARY: In the same way that the Human Genome
Project was disrupted by the entry of C. Craig Venter and Perkin-
Elmer in what was then a 15-year, $3 billion project, now
Complete Genetics of Mountain View, California, is disrupting the
race to the $1,000 human genome sequence. Developments in
this field are moving at rocket speed and the resulting new technologies
and instrument systems may give laboratory medicine
new clinical assays that are disruptive in their own right.
ICD-10 Conversion Costs
Underestimated by HHS
Laboratories and physician groups to incur
significant expenses when implementing ICD-10
Department of Health and Human Services
publishes ICD-10 launch date of October 1, 2011
CEO SUMMARY: Criticism of the October 1, 2011 implementation
date for ICD-10 is building. Last week, a new study
was released that highlights how federal officials underestimated
the costs and time required to implement the complex
new codes for ICD-10. One large national laboratory company
estimates it will spend at least $40 million to prepare for ICD-
10 implementation. Officials from groups such as AMA and
ACLA are voicing strong concerns on this matter.
Hospital Labs Have New
Options for Molecular Dx
Combination of growing physician demand
and new molecular technologies open door for labs
CEO SUMMARY: Laboratories that offer molecular assays
continue to see strong growth in four areas: oncology,
hematopathology, infectious diseases, and personalized medicine.
Further, a new generation of molecular testing systems
and analyzers is coming to market which will make it easier
for even smaller community hospital laboratories to establish
and perform molecular tests that are both clinically useful and
financially sustainable.
Molecular Dx Update: LabCorp's Ovarian Cancer Test
Generates FDA Warning Letter
Lab Briefs: SIEMENS INVESTS
IN DIGITAL PATHOLOGY,
BUYS STAKE IN BIOIMAGENE
SIEMENS INVESTS
IN DIGITAL PATHOLOGY,
BUYS STAKE IN BIOIMAGENE
MAYO CLINIC USES RFID
SYSTEM TO REDUCE TISSUE
SPECIMEN LABELING ERRORS
Pathology Boot Camp
To Address Three Trends
Challenges for anatomic pathology groups
include pricing, competition, and technology
CEO SUMMARY: Anatomic pathology groups across the
nation must develop effective strategies to address challenges
in pricing, intensifying competition, and expensive new technologies.
That's the assertion of three pathology practice
administrators who have organized a boot camp in Dallas next
month specifically to train other practice administrators and
managers. This event will provide administrators from any size
pathology group with useful skills and insights.
INTELLIGENCE: Late & Latent
CONSUMER ACTIONS
FOCUS OF NEW
GENETIC STUDYLAB IN FLORIDA OFFERS
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