Need Better Standards for Your Clinical Assays? NIST Can Help

Kenneth Cole, Group Leader, Bioassay Methods Biosystems and Biomaterials Division at the National Institute of Standards and Technology (NIST)

Bio and Contact Info


0:00 How can NIST help the Dx industry?

4:46 Establishing new and higher standards for HER2 testing

10:09 Over 40,000 papers on cancer biomarkers each year

13:42 Digital PCR proving powerful

21:06 Partnering with the community

The life science tools space is flourishing. Biomedical research output is at an all time high. Today’s guest says there are over 40,000 papers published each year on cancer biomarkers.

But very few of those become commercialized tests. Why?

Many had hoped the FDA would step in and save the diagnostics industry from itself, from a race to the bottom when it came to being able to reproduce clinically relevant tests. But that’s obviously on hold. In the meantime, others are stepping in. And there is one government agency which has no regulatory authority but some power to help out.

Kenneth Cole is the group leader for developing bioassay methods and standards at the National Institute of Standards and Technology. His group has just created a new set of standards and methods for HER2 testing which is available to the clinical lab community to help improve their own assays. It’s been said on the program that this very common test for use in cancer therapy has a false positive rate of 20 percent. That's too many patients getting told the wrong thing.

Ken’s group is now going to work on EGFR and other common tests, and they can help the testing community in several ways. First of all, Ken says, they have a “the luxury of being able to focus in on the measurement techniques and on examining all the sources of variability in an assay." They also work on characterizing cell lines, which have become “an essential part of modern biology.” Ken says a big part of the work at NIST is the education of the community and of the new crop of scientists.

Do you have an assay you’d like help with? Ken is easy to reach, and NIST welcomes your requests. They have set up many partnerships from loose collaborations to projects with IP protection.

Often the best place to find solutions is in going back to the basics.

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