We share the excitement evidenced in your article about gene-based research using
tissue banks (March 2003, page 1). That’s why, in 1999, Impath
Inc. launched the Impath predictive oncology (IPO) division and
its GeneBank tissue, serology, and information archive.
GeneBank consists of more than 12,000 well-characterized, fully consented tissue samples
with rights to followup data over a multi-year period. This tissue
and information archive procures only oncology specimens, with each
sample undergoing a standardized pathology review after it is collected
in accordance with well-defined, institutional-review-board-approved
In the relatively short time we have been developing this resource, we have established
relationships with many academic medical institutions and hospital
centers. We have participated in projects with numerous biopharma
companies leading oncology drug discovery and development.
Impath’s exclusive focus on cancer positions our IPO division to play a growing
role in bringing the next generation of novel gene-based therapies
to market for cancer patients.
Chairman and CEO
In the March issue of CAP TODAY (page 112) there was a question and answer about
the stability of specimens for vitamin B12 and folate,
with specific reference to Quest Diagnostics. The conclusions of
the responders, Frederick Kiechle, MD, PhD, and J. Douglas Ferry,
PhD, may be misleading, especially to physicians and hospitals that
depend on the accuracy and reliability of testing performed within
our network of laboratories.
Quest Diagnostics, like laboratories across the country, is dedicated to providing
physicians with laboratory results that accurately reflect the analytes
measured. We base our guidelines for specimen preparation on both
published and internal studies.
First, the responders cite a study published in Clinical Chemistry that indicates
specimens are stable when exposed to light for up to eight hours
(Mastropaolo W, Wilson MA. Clin Chem. 1993;39:913). This
is consistent with the specimen requirements listed in our manuals
because few specimens are exposed to light for more than this length
of time. Specimens are stored in refrigerators and collection boxes
before pickup. Couriers transport specimens in coolers and containers
that are protected from light. Analysis is frequent, with nearly
all test results available the next morning. Thus, the published
study applies to the typical specimen tested by Quest Diagnostics.
Second, Quest Diagnostics has performed internal studies that support exposure
to light for up to 24 hours. These studies form the basis of our
recommendations in our manuals and on our Web site. We found no
significant clinical change in the concentration of vitamin B12
in specimens exposed to light for up to five days, and our findings
for folate, when specimens are exposed to light for up to 24 hours,
Third, we review the distribution of test results to ensure it is what we expect.
For these two analytes, less than three percent of results fall
below the reference range. If degradation were affecting the analysis,
the percentage would be significantly higher. Thus, we are assured
that we are observing the reporting of an expected distribution
of results without degradation due to excessive exposure to light.
Quest Diagnostics stands by its published specimen requirements for vitamin
B12 and folate. We urge other laboratories to perform studies that
define the specimen requirements based on their processes and equipment.
W. Kaufman, MD
Medical Director, Hospital Services