Accurate Results, Innovative Tools:
The NIST Role in Health Care and Bioscience
|
© Robert
Rathe |
| NIST
researchers have nine patents related to microfluidic
devices, such as "lab-on-a-chip" systems that one day
may be used for quick tests in physician's offices. |
Your
doctor probably advises you to have your blood cholesterol
measured regularly because high levels are one of the major
risk factors for heart disease, the number one killer of
Americans. But 35 years ago you had nearly a one-in-five
chance of being misdiagnosed—cholesterol screening
tests were inaccurate by about 18 percent. By the year 2000,
that had been cut to 3 percent.
A significant
part of that difference was due to the National Institute
of Standards and Technology (NIST). Working with the College
of American Pathologists and the Centers for Disease Control,
NIST developed definitive measurement methods and a range
of Standard Reference Materials® for calibrating
analytical instruments, and helped to establish and now maintains
a reference system for cholesterol measurements.
Cholesterol
measurement is only one example of NIST’s
growing impact on health care and bioscience. Modern health
care is a measurement-intensive business. U.S. health care
currently costs an estimated $1.9 trillion annually, and
as much as 15 percent of that is spent on measurement. Of
that, it’s estimated that 25 to 30 percent is spent
on “non-diagnostic” measurements—repeat
tests and error prevention and detection.
| Radiation
therapy beams from medical linear accelerators, used
to treat about 500,000 cancer patients annually,
are quality controlled with dosimeters calibrated
against NIST standards. |
Cholesterol
measurement is only one example of NIST’s growing impact
on health care and bioscience. Modern health care is a measurement-intensive
business. U.S. health care currently costs an estimated $1.9
trillion annually, and as much as 15 percent of that is spent
on measurement. Of that, it’s estimated that 25 to
30 percent is spent on “non-diagnostic” measurements—repeat
tests and error prevention and detection.
Through research, improved test methods and data, and dozens
of clinical and health-related reference standards, NIST
is helping clinical laboratories, medical manufacturers,
hospitals, drug makers, and biomedical researchers improve
the accuracy of medical tests, saving money while also improving
patient outcomes.
NIST also plays an increasingly important role in bioscience
research. Twenty-first century life sciences draw heavily
on almost every other scientific discipline—physics,
engineering, and surface science for nanotechnology; mathematics,
physics, chemistry, electronics, and information science
for gene sequencing and genome research. NIST’s unique
cross-disciplinary perspective and research capabilities
allow it to bring tools and expertise from all these disciplines
to bear on the key challenges in bioscience. NIST health-care
and bioscience programs also benefit from the Institute’s
world-class facilities and partnerships with universities
and other government agencies.
NIST produces
more than 90 reference materials used for quality control
in clinical tests and reference methods for 27 health
indicators measured
in blood and urine. |
Health
care and bioscience projects at NIST span a broad range
of activities, from basic research on the measurement of
single molecules or the behavior of cell membranes—nano-bioscience—to
clinical applications such as calibrations of mammography
equipment. There are more than 150 such R&D projects
under way in the NIST laboratories. Since 1990 NIST has contributed
more than $500 million to cost-shared, industry-led advanced
research projects in health care. NIST also recently launched
a joint postdoctoral program with the National Institutes
of Health to train future bioscience researchers.
Here
are just a few examples of NIST contributions to health-care
technology:
Screening and Prevention
© Robert
Rathe |
| NIST
DNA reference sample help improve the accuracy of tests
for genetic traits. |
 Women undergoing mammography exams at accredited U.S.
clinics are assured of receiving proper X-ray exposure with
the help of a NIST mammography radiation standard and instrument
calibration facility. Instrument manufacturers and inspectors
use these tools to help ensure that clinical exposures
are within regulatory limits. Nearly 30 million mammograms
are performed each year in more than 9,000 U.S. clinics.
To help researchers worldwide assess whether vitamins
and other micronutrients deter the development of cancer,
NIST evaluates the capabilities of more than 40 clinical
laboratories to assure that their measurements are sufficiently
precise and accurate for valid comparisons. NIST has helped
the participating labs improve their measurements of nutrients
such as vitamin A, vitamin E, vitamin C, and beta-carotene
by a factor of two or more.
Advances
in our understanding of the human genome underlie a growing
number of DNA-based tests for medical diagnostics and screening,
but such complex tests can be difficult to interpret accurately.
NIST is developing a range of DNA reference materials to
help clinical labs ensure the accu-racy of their results.
One such is a reference material for diagnosing “Fragile
X Syndrome,” a genetic mutation that has been linked
to several physical abnormalities and to intellectual problems
ranging from minor learning disabilities to severe mental
retardation and autism. Another simplifies paternity testing
and eliminates problems distinguishing between male and female
DNA in identity and forensic tests.
Diagnostics
Protein Data Bank |
| Computer
model of the heart protein, troponin. A new NIST standard
is expected to greatly reduce variations in clinical
measurements of this key protein used in diagnosing
heart attacks. |
Fluorescent
markers are often used to “tag” antibodies,
cancer cells, genes, or other biomolecules in a variety of
tests. NIST’s recent development of new theory, standards,
and methods provides an authoritative measurement scale for
intensity—reflecting numbers of target molecules—that
increases confidence in results of these tests. Future diagnostic
tests may use “quantum dots” just 15 nanometers
wide that give off signals that are 200 to 1,100 percent
more intense than those from conventional tags and also are
more stable when exposed to light. NIST scientists have demonstrated
that quantum dots could improve the reliability of important
diagnostic tests for breast cancer and other conditions.
Nanotechnology is poised to play an increasingly important
role in 21st-century health care—and NIST is a leading
center in nanotech research.
"Gene
chip” microarrays have become possibly
the single most important new technology for DNA-based diagnostics
and medical research. The field was jump-started by several
cost-shared industrial R&D awards under NIST’s
Advanced Technology Program, and NIST is now helping to lead
a consortium of companies, universities, and federal laboratories
to develop critically needed reference standards and controls
for gene chips and other DNA analysis technologies.
The
NIST Cancer Biomarker Validation and Reference Laboratory—one
of five such centers in the National Cancer Institute’s
Early Detection Research Network (EDRN)—assesses cost,
efficiency, and reliability of new cancer diagnostic techniques
coming out of EDRN labs. NIST analysis helps validate the
use of potential biomarkers for early cancer detection and
provides standardized methods for biomarker detection and
analysis to other research and clinical labs in the network.
NIST
is one of only two national measurement institutions
in
the world that provide power calibrations for excimer
lasers used in medicine, such as for vision correction
surgery. |
National Cancer Institute |
| Electron
micrograph of a single breast cancer cell. NIST research
to develop a new chemical analysis method is helping
the National Institute of Alcohol Abuse and alcoholism
better understand chemical links between alcohol consumption
and cancer. |
Treatment
“Smart” dental
materials developed at NIST can stimulate repair or even
regeneration of damaged teeth. These novel polymer composites
release a steady supply of calcium and phosphate ions that
induce teeth to heal themselves. This patented technology
has been converted recently into several commercial dentistry
products, yet another successful result of a long-standing
partnership between NIST and the American Dental Association
that has produced innovations such as the forerunner of
the high-speed dental drill and the panoramic X-ray machine.
NIST
calibrates radiation doses from tiny radioactive seeds
that can be implanted in or near tumors or positioned in
arteries. Doctors are using the seeds instead of external
radiation sources for prostate cancer patients and to prevent
re-closing of heart arteries following angioplasty treatment.
NIST is the only laboratory in the world that offers calibrations
of radioactive seed sources for prostate cancer. Future radiotherapy
sources may be even smaller. NIST researchers are working
with medical scientists to develop a way to target cancer
tumors with short range, energetic alpha particle radiation
delivered by radioactive nanoparticles carried by antibodies
to tumor sites.
Standards
and Quality
T. Nguyen, National Cancer Institute |
| NIST
worked with the U.S. Army Medical Research Institute
of Infectious Diseases and the National Cancer Institute
to use artificial cell "nanopores" to rapidly
detect anthrax toxins at ultra-low concentrations. |
Experts
estimate that better use of modern information technology
in the health-care industry could reduce the nation’s health bill by up to 30 percent,
or $570 billion a year, not to mention savings of tens
of thousands of lives lost to preventable errors. Health
care has lagged behind other industries in part because
of a lack of common standards. To help bridge this gap,
NIST is collaborating with industry, standards organizations,
government agencies, and others to advance the adoption
of information technology within health care systems. For
example, NIST is developing a web-based Health Care Standards
Landscape, a comprehensive source of health care standards
information.
NIST
work in health-care standards can be an important factor
in industrial competitiveness as well. U.S. makers of in
vitro diagnostic (IVD) medical devices—such as
those used to measure blood levels of cholesterol or glucose—can
ensure that their products meet new requirements for sale
in Europe by using a database that identifies acceptable
calibration procedures and materials. NIST played a key role
in establishing the database, working with the international
diagnostic device community. The database should facilitate
worldwide comparability of clinical measurements, improving
patient care, and reducing technical barriers to trade and
costs for IVD manufacturers. It also helps U.S. firms maintain
their position in the $7 billion European market where they
now have more than 60 percent of the business.
| A
NIST-led research team identified a subtle structural
change that may play a role in the molecular machinery
for making the virus that causes AIDS. |
Seven
health care organizations have received NIST’s
Malcolm Baldrige National Quality Award, which recognizes
performance excellence and quality achievement by U.S. manufacturers,
small businesses, service companies, educational organizations,
and health-care providers. ADAC Laboratories and 3M Dental
Products Division won in the manufacturing category. Since
health care was added as a separate award category in 1999,
winners have included Bronson Methodist Hospital of Kalamazoo,
Mich.; SSM Health Care of St. Louis, Mo.; Baptist Hospital
Inc. of Pensacola, Fla.; Saint Luke’s Hospital of Kansas
City, Mo., and Robert Wood Johnson University Hospital Hamilton
(N.J.).
Bioinformatics
©Robert Rathe |
| NIST
physicists are measuring the optical properties of
single nanocrystals—clusters of atoms about
10 nanometers or smaller that glow different colors depending
on their size—to help medical researchers better
calibrate tests using this new nanotechnology. |
To
enable faster, more affordable health-care services—particularly
for patients in remote locations—NIST and the American
Telemedicine Association are working together to define a
portfolio of standards and guidelines for use in tele-retinal
imaging to assess diabetic retino-pathy. Similar efforts
for other medical disciplines are planned.
Shortly
after it was launched in the summer of 2004, the web-based
HIV Structural Reference Database (HIVSDB) became one of
NIST’s
most popular data services. An information resource for
the HIV research community, the HIVSDB collects, annotates,
archives, and distributes structural data for proteins
involved in making HIV, the virus that causes AIDS, as
well as molecules that inhibit the virus.
The
Center for Advanced Research in Biotechnology, jointly
operated by NIST and the University of Maryland Biotechnology
Institute, conducts bioinformatics research to help make
sense of the large amounts of molecular, genetic, biochemical,
and structural data generated by new scientific tools.
For instance, a software system has been developed that
will allow evolutionary analyses of sequence features to
be carried out using hundreds of sequence families at a
time. The software has been used to settle a long-running
debate over the origins of so-called “junk” DNA.
©Geoffrey
Wheeler |
| NIST
researchers are studying what conditions produce the
best cell growth on polymer scaffolds. A bioreactor
(foreground) is used to test whether the resulting engineered
tissues can withstand mechanical stresses similar to
those produced by a beating heart. |
Biomedical
Science and Technology
The
new research field of tissue engineering is probing the
use of engineered biomaterials to replace damaged or defective
tissues, such as bone and skin—perhaps even
organs. Biodegradable materials, for example, might temporarily
stabilize damaged ligaments or cartilage while acting as
a scaffold for new tissue growth. NIST is applying state-of-the-art
imaging, cell culture facilities, and computer modeling to
help researchers from universities, industry, and other federal
labs measure key factors of cell growth to enhance the design
of compatible, degradable biomaterials.
NIST
is building on its expertise in spectroscopy, laser science,
microfluidics, and atomic manipulation to develop technologies
to rapidly manipulate and screen individual molecules for
possible applications in biological and forensic research.
For instance, NIST scientists have demonstrated an array
of magnetic traps designed for manipulating biomolecules
and measuring the ultrasmall forces that affect their behavior.
The chip-scale, microfluidic device works in conjunction
with a microscope to serve as magnetic “tweezers” that
can stretch, twist, and uncoil molecules such as strands
of DNA.
| NIST's
MitoAnalyzer software enables scientists to determine
how small variations in human mitochondrial DNA affect
protein production. |
Super-chilled
neutrons produced in a unique NIST facility are being used
to probe the structure and interactions of cell membranes
and their components, generating information that can be
used to improve disease diagnosis and treatment. NIST collaborations
with university scientists at this facility also may help
guide the design of new tissue-engineered medical devices.
The NIST facility is considered one of the best in the
United States and serves more users than the nation’s
other three neutron sources combined.
To
receive a paper copy of this brochure, please contact inquiries@nist.gov |
