Dr. Ellen Goes to Washington

…to testify at a hearing at the US PTO involving Myriad Genetics and its patenting of the BRCA genes. Myriad’s patent covering its nucleic acid-based test is broad enough to hinder development of alternate tests and BRCA-related research. In addition, Myriad has refused to grant licenses to multiple testing labs, making the test prohibitively expensive for anyone whose medical insurance does not cover work done by Myriad;s designated lab- about $3500 for a test that costs a couple hundred to actually perform. So Genspace President Ellen Jorgensen testified at a hearing discussing whether or not Myriad should be required to loosen their legal hold on the BRCA gene. After all, the original research was all done with public funding, our tax dollars at work! She also made a case for allowing people to perform the test on themselves, without going through a lab.

The testimony was the second-to-last of the hearing. A video of the webcast of the event is on this page under Public Hearing (February 16, 2012) . A transcript of the testimony follows:

First, I’d like to thank you for allowing me this opportunity to testify. We’ve heard a lot about the rights of the biotech companies, and I’m sort of here to represent the consumer.

I’d also like to bring this discussion into the 21st century. My name is Ellen Jorgensen. I have a Ph.D. in cell and molecular biology. I conducted genomics research for many years, I was in the biomarker field, I do have
patents that contain genes in them, I will admit.

But currently, I’ve turned my back on all of that and I’m president of Genspace, which is a nonprofit community biotech lab. This is dedicated to promoting citizen science and access to biotechnology for all.

Our members include a broad spectrum of people, everything from artists, biologists, architects, engineers, university faculty, and since 2009, we’ve served the greater New York area by providing subscription-based access to a biosafety level 1 lab where we run educational programs in life sciences, laboratory safety, and for independent research. I ask that the commissioner consider my viewpoint in light of my experience in scientific research and in biotech education, and I’m sort of an educated consumer, if you will.

I am appearing here before you today to affirm my conviction that the right of an individual to conduct an inquiry into his or her own genome is more important than genetic patents. The current debate assumes that
individuals cannot perform the tests for themselves on themselves. Due to the rise of citizen science and the democratization of technology, a growing number of individuals can and will test their own genotypes. The cost of
setting up a home lab, performing genetic analysis on one’s own DNA is less than $5,000 and could even be cheaper than that if you get everything off eBay.

Some day soon — and this is happening right now — sequencing one’s own DNA will become as much a part of high school science curricula as dissecting frogs. At Genspace, I hold classes for adults and high school students that teach them how genetic tests are performed and give them hands-on experience in the lab techniques necessary.

So, I hold in my hand a vial of my own DNA. I extracted it at Genspace using a procedure that’s simple enough for a middle-schooler, and I’m not allowed to analyze it because of patent concerns. By the way, the
CCR5 test that was mentioned by one of the previous speakers costs about $10 bucks in reagents to do and is very, very simple.

Some of the other tests, obviously, are more expensive, like the BRCA where you have to sequence the whole gene, but if you already have that information in your family — say, your mother was BRCA positive and you know her sequence — you could probably do it for a lot less. You could probably just zero in on a part of the genome that you know she has mutations in and, again, turn it into a very, very cheap thing to do and very easy. Because the science behind this, a lot of it, is 30 to 40 years old.

So, it’s just incomprehensible to me that by seeking to know something so unique and personal as my own genotype, that I may be violating a patent and since 100 percent of known genes, according to a recent analysis by Dr. Chris Mason, who I know who has testified before this committee and is a professor at Weill Cornell Medical College at their computational genomics center. He’s at Cornell Wyle Medical College in their computational genomic center. He estimates that 100 percent of known genes are all covered by some sort of patent at this point in time. So, this has the potential to shut down this whole area of science education, and personal genomic exploration.

I feel this area is really important to promoting science literacy. These powerful technologies will change our lives, they’ll impact everything from our health to energy to the food we eat, and the best way to inform the
dialogue about 21st century science is to have the stakeholders understand it from a hands-on perspective.

So, should I avoid teaching these subjects completely because of genetic testing patents? I feel if the progress of science and education is to continue, that students, teachers, and the intellectually curious can’t fear patent infringement or licensing fees, and I don’t feel confident that current laws protect us sufficiently. I’m also just personally uncomfortable with the whole concept of patenting a naturally-occurring nucleic acid sequence, particularly since much of this information was gleaned through government-supported scientific research that all of us paid for with our tax dollars.

So, based on my experience as a scientist, an educator, I’d like to see some sort of an exemption that permits individuals to perform patented genetic tests on their own genomic material, and an exemption for educators
who teach individuals how to perform these tests because I think that in the end, it’s critically important to all of us who strive to foster innovation and science literacy — and also, from what I’m hearing here, there may be a problem with some people having access to some of these tests because of monetary concerns. And if you do it yourself it costs a lot less.

I’m sure we can do BRCA testing for a lot less than $3,500 a sample. If someone came into our lab and said they wanted to do it they could do it on themselves for considerably less, particularly if they had information from a
family member’s genomic material already.

So, that’s all I really want to say. Thank you very much.

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