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Performance
of 50 Completed ATP Projects
Status
Report - Number 2
NIST SP 950-2
Chapter
2 - Advanced Materials and Chemicals
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BioTraces,
Inc.
Highly Sensitive Detectors for Biomedical
and Environmental Diagnostics
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technology that can detect minute traces of biomolecules — pesticides,
bacteria in water, organic toxins like botulin — much better
than conventional detectors would be extremely useful in a number
of fields. Medicine, for instance, has obvious need for highly sensitive
methods of detecting viruses. Such a technology would also be applicable
in a broad range of environmental areas, where early detection of
chemicals or other substances could trigger corrective action early
enough to head off disaster. Detecting traces of toxic materials in
a municipal water supply, for example, might lead to the elimination
of their source before they poison the city’s population. A highly
sensitive detection technology could also be useful for the optimized
control of semiconductor fabrication. |
COMPOSITE
PERFORMANCE SCORE
(Based on a four star rating.)
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Detecting Minute Amounts of Unwanted Molecules
This ATP project created such a technology through the efforts of BioTraces,
a small company founded in 1989 to develop, manufacture, and market instruments
for detecting microtraces of various materials. During its ATP project,
the company developed a highly sensitive biomolecule detection method
based on an improved radioactive tracer detection system originally developed
for cosmology. Instruments of this types use radioactive isotopes that
are chemically bound to the target molecules or atoms. Photon or electron
detectors that register radiation decay particles are used to spot the
“tagged” targets. Sensitivity is limited by background radiation
— 10 to 100 counts per minute for conventional commercial instruments
in typical applications. BioTraces beats this limitation with a sophisticated
multiphoton detector (MPD) that registers only counts that match the multiple-photon
decay pattern of the isotopes used as tags. In contrast to conventional
methods, background levels for BioTraces detectors are a few counts per
day.
Safer Analyses for
Patients and the Environment
The BioTraces technology uses different isotopes to tag different types
of molecules in the sample. This allows several different molecule types
to be measured simultaneously, greatly speeding complex analysis tasks
such as those used in clinical screening (for example, to detect contaminants
in blood supplies). Since background interference is so low, the minimum
amount of isotope needed for an analysis can be as much as 1000 times
less than that used in conventional radioisotope analysis, making the
BioTraces system considerably safer for patients and the environment.
The company met most
of the project’s technical goals. Its researchers developed prototype
MPD instrumentation hardware and software that is much more sensitive
than current state-of-the-art equipment. They also developed biomedical
applications of the technology for enhanced immunoassay, chromatography
and nucleic
acid analysis.
First Fruits of Commercialization
At the start of the ATP project, BioTraces planned to do only the instrumentation
work and to leave specific applications to partner companies. But lack
of success in finding suitable partners led BioTraces to change its approach
to commercialization. It is now finishing development
work on the MPD technology and hopes to begin offering its own commercial
products widely in the near future. The company has made enough progress
to license the technology exclusively to a new company, PetroTraces, for
petrochemical applications. PetroTraces uses it to tag and trace different
liquids and gases that are transported in pipelines so it can supply customers
with data for auditing and other applications.
BioTraces’ own
initial commercial product, the ssMPD (sequential sample MPD) is used
for super-sensitive measurement in extremely small samples — up to
a few milliliters. The ssMPD received market clearance from the U.S. Food
and Drug Administration for sale as a clinical diagnostics device and
entered the market in 1997 on a limited basis for use in research. BioTraces
expects to launch wide-scale sales of the ssMPD in late 1998 or early
1999, after enhancing protection for its proprietary software and establishing
a strategic alliance with a major clinical diagnostics company.
The new MPD technology
has great potential as an advanced biomedical diagnostic tool and for
other uses where detection of minute traces of biomolecules is critical.
BioTraces entered an agreement with Pasteur-Merieux Connaught, a French
company, under which it developed an MPD-enhanced quantitative polymerase
chain reaction assay for measuring tiny amounts of deoxyribonucleic acid
(DNA) and ribonucleic acid (RNA). And in June 1997, it arranged for Genetics
Institute, Inc., to evaluate the MPD technology as a pharmaceutical research
and development tool. If the test is successful, it could lead to a license
allowing Genetics Institute, Inc., to use the technology in its drug discovery
program.
ATP Gives a Big Boost
to a Small Startup
BioTraces is a very small company, having only three employees when it
started the ATP project. Since then, the company has received $1 million
in equity investment to support commercialization of the new technology.
It has also entered into discussions with two venture capital firms about
securing an additional $4 million in equity funding in 1998.
Company officials
report that the ATP award enabled BioTraces to achieve its research results
two to three years sooner than it otherwise would have been able to do.
The funds also
helped it develop research alliances and improved its ability to raise
investor capital.
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Project
Highlights
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PROJECT:
To develop instrumentation based on multiphoton detection (MPD),
high-speed/high-sensitivity sensors and proprietary software, one
that can detect minute concentrations of chemicals in gas, liquid
or solid matrices — a technology that would be extremely useful
in environmental monitoring and biomedical research.
Duration: 1/1/1994 — 12/31/1996
ATP Number: 93-01-0250
FUNDING (in
thousands):
| ATP |
$1,718
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69%
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| Company |
773
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31%
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| Total |
$2,491
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ACCOMPLISHMENTS:
BioTraces developed MPD instrumentation, both hardware and software,
as well as biomedical applications of the technology for enhanced
immunoassay, chromatography and nucleic acid analysis. The company:
- applied for
two patents on technology developed during the ATP project:
“Enhanced Chromatography Using Multiphoton Detection”
and
“Ultralow Background Multiple Photon Detection;”
- negotiated
with the French company Pasteur-Merieux Connaught an agreement
under which BioTraces developed an MPD-enhanced quantitative polymerase
chain reaction assay for measuring tiny amounts of DNA and RNA;
- negotiated
a $1.78 million agreement in July 1996 with a newly-formed company,
PetroTraces, granting it an exclusive license for commercial applications
of the new technology in the petroleum industry — a deal
that so far has generated $585,000 in revenues for PetroTraces
and $560,000 in license fees for BioTraces;
- arranged
in June 1997 for Genetics Institute, Inc., to evaluate the MPD
technology as a pharmaceutical R&D tool; if successful, the
testcould lead to a license allowing Genetics Institute, Inc.
to use the technology
in its drug discovery program;
- created a
clinical diagnostics device, the ssMPD™ (sequential sample
MPD), which received market clearance from the U.S. Food and Drug
Administration and entered the market on a limited basis in 1997;
- has received
since the start of the ATP project $1 million in equity investment
to support commercialization of the new technology; and
- entered into
discussions with two venture capital firms about securing
an additional $4 million in equity funding in 1998 or 1999.
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COMMERCIALIZATION
STATUS:
Commercialization is in progress. Applications of the technology
are underway in the petrochemical field via PetroTraces. BioTraces’
first commercial product for medical applications, ssMPD™,
has entered the market on a limited basis and is expected to be
more widely available in 1998 or 1999.
OUTLOOK:
Once BioTraces works out a strategy for protecting its intellectual
property, the new technology is expected to be disseminated more
aggressively.
Given its potential
use in detecting viruses, bacteria, toxins and pollutants, the ATP-funded
technology stands to generate substantial benefits to the economy.
If, for example, it were used to detect a toxin in a water supply,
preventing a whole town or region from becoming ill, the benefits
would be enormous.
Composite
Performance Score:
COMPANY:
BioTraces, Inc.
10517-A West Drive
Fairfax, VA 22153
Contact: E. James Wadiak
Phone: (703) 273-6941
Number of Employees: 3 at project start, 14 at the end of
1997
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Return to Table
of Contents or go to next section.
Date created: April
2002
Last updated:
April 12, 2005
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