NEW DISCOVERIES in the biological sciences and biotechnology have the potential to transform health care, energy, national security, the environment, manufacturing, agriculture, and many more areas that impact society. But measurement standards haven't kept up with the rate of discovery, making it difficult for research to move beyond the laboratory.
The National Institute of Standards & Technology (NIST), well-known for its metrology expertise in an expansive array of physical science and engineering disciplines, is taking the situation seriously and beefing up its efforts in the biosciences area. To that end, NIST joined forces with the University of Maryland Biotechnology Institute (UMBI) and held a meeting in October to address the measurement challenges faced by the biosciences.
The three-day meeting included heads of metrology institutes from around the world and people with an interest in providing confidence in measurements in complex biological systems. The goal of the gathering was to help NIST prioritize its efforts.
"We are sitting at a perfect storm between the rapid pace of discovery in the biosciences and the impact that it's having on all of the fields of science," Patrick D. Gallagher, acting director of NIST, said in his introductory remarks at the meeting.
NIST has a specific mission "to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life," Gallagher said. "It's simply impossible to touch any one of the major societal areas and not realize that the biosciences and biotechnology will be a major player."
"We are sitting between the rapid pace of discovery in the biosciences and the impact it's having on all of the fields of science."
The measurement challenges posed by the biosciences are immense, and overcoming them will likely require international collaboration. "Biology or biotech is global today. If we could leverage both human resources and financial resources to go after many of these desires for new measurement tools, it would benefit the global market," said Jennie C. Hunter-Cevera, president of UMBI.
Because of the global nature of this area, NIST is looking to its counterparts around the world for input regarding the development of standards and measurement tools for the biosciences.
At the meeting, Alejandro Herrero Molina, director of the European Commission's Joint Research Centre Institute for Reference Materials & Measurements, offered his views on what are likely to be important metrology issues in the biosciences in Europe over the next five to 10 years. He provided examples such as confirming the authenticity of food products or detecting fraud, distinguishing organically grown crops from conventional ones, and characterizing allergens both before and after food processing. Genetic testing, personalized medicine, and genetically modified crops for nonfood industrial applications are also important areas that need standards, he noted.
In general, meeting participants raised concerns about the lack of access to appropriate information technology databases, the inability to transfer data from one type of measurement platform to another, and the need for dynamic, real-time measurements. By creating universal standards, NIST could help ensure that databases are connected and can talk to each other, meeting participants suggested.
Attendees also pointed out that there are few standards with respect to how genetics and protein data are assessed. They specifically noted the areas of synthetic biology and systems medicine. Developing such assessment standards is one place where NIST should focus its efforts, attendees said.
One important example of the need for standards in medicine that was raised by several people at the meeting is the reliability of routine health-related measurements. For example, a test as common as the one for the risk of prostate cancer can be unreliable because a universal standard does not exist. "The value you get for prostate-specific antigen depends on what calibrator was used. You can go from being at risk to being so healthy that you can be ignored on the basis of not a change in you, but a difference in the standard that is used," Craig Jackson, a consultant and retired biochemistry professor from Washington University with experience in the in vitro diagnostics industry, explained to C&EN after the meeting.
TWO AREAS that NIST is currently thinking about are standards for medical imaging and protein measurement science, according to Willie E. May, director of NIST's Chemical Science & Technology Laboratory. Optical and chemical imaging tools could allow rapid, real-time measurements, he added.
Funding this effort will require some tough decisions. NIST does not have the staffing and the core competencies needed to address those areas and so would need to ask Congress for additional financing, May noted.
Getting such additional funding may not be possible in the current budget crunch. As a result, the agency is also taking a close look at all of its units, including the chemical sciences, to see whether some of those resources can be reallocated to the biosciences. In fact, NIST already has redirected funds to get started on developing biosciences standards.
"NIST has about $6 million specifically for work in the biosciences," May said. "We are doing more than we've been appropriated. So each of the major organizational units has made decisions to reprogram some of their existing resources to support activities in the biosciences."
The October meeting undoubtedly gave NIST more ideas to think about as it prioritizes its next formal request to Congress for additional money in biosciences.