In Part III of our interview with Dr. Qin Shi of Edgetech Law we visit the concept of human genome sequencing as a mainstream commodity. Dr. Shi is optimistic that genome sequencing can become an affordable and intriguing choice for patients and curious individuals, however she identifies the potential quandaries the FDA and other regulatory bodies face. In this last part of our interview, we also touch on the JOBS Act – a law which Dr. Shi says may spur funding for diagnostics and other life sciences firms.
If you missed Part I or Part II, click here.
Brett Johnson: You previously worked in the genomics area at the time when the human genome was first sequenced. Do you see that genome sequencing will eventually be commodified for the general public, aka: hit the $1000/test mark?
Dr. Qin Shi: Still today I have hanging in my office the original, large human genome map based on Celera’s genome sequence published in the February, 2000 issue of Science magazine. That was a very interesting time; and we have come a long, long way. My colleagues in the NIH and FDA tell me that $1000/test is in the near horizon.
My guess is that, if we use the downward trajectory of the cost of microprocessors in recent decades – while their speed goes up – as a cross reference, we will be seeing the cost of sequencing coming down. More relevant, as we have competition in the market among some of the best companies in the space, the cost is going to go down further. Genome sequencing can indeed be heading towards commodity tests in wellness labs around the world.
BJ: What are regulatory bodies saying about genome sequencing?
QS: That would be a different question. In fact, you may be touching on a complex area of regulatory policy where changes are expected. For example, in the field of direct-to-consumer genetic testing, if it goes beyond recreation and wellness – such as searching for ancestry or choosing suitable supplements – and becomes what’s called direct-to-consumer medical or diagnostics genetic testing, a series of federal and state laws will become applicable. Most notably this includes the Clinical Laboratory Improvement Amendments of 1988, which regulates clinical labs where tests are run, and patient protection and privacy laws at the state level.
Additionally, the claims are subject to the oversight by the FTC for consumer protection. Moreover, the FDA has the authority to regulate some of those tests depending on how they are administered – such as Laboratory Developed Tests (LDTs) or In Vitro Diagnostic Multivariate Index Assay (IVDMIA). And yet, there is lobbying for new legislation to regulate DTC companies. As the market matures, so will we hopefully see the regulatory framework clears up in this area.
BJ: Talk about the JOBS Act for a bit. Will healthcare companies and diagnostics companies in particular, find any use for crowdfunding?
QS: It may be a bit too early to tell. It may not be until 2013 when the SEC starts to issue corresponding rules on crowdfunding. Theoretically, this expands on the traditional angel model, and provides alternative sources for funding to start-ups. However, there are many pieces to how this would actually work, and ensuring regulatory compliance will have some additional cost. Again, it’s a bit too early to tell whether this paradigm will be a success and will fuel the growth of diagnostics and other healthcare companies.
BJ: Speaking of JOBS, why do you seek experienced lawyers/advisors previously in science and engineering? Why do they find success at Edgetech Law?
QS: We believe it is important to work with like-minded people who share the same passion. Those who have had varied experiences in life, including in science and engineering, or business and law, have an edge to excel in what we focus on – which is to bring value to our client’s technology ventures and to help make things happen.
BJ: What is in store for the future of EdgeTech Law?
QS: We are still quite young, just about two years old. We have a unique platform that delivers for our clients, and we intend to grow. We enjoy the energy, creativity, and flexibility in our work, and most certainly enjoy being close to new technology developments. As a boutique firm, we have the flexibility to delve deeper in technologies and act as a close advisor/counselor or “partner” as needed to best serve clients’ ventures. That’s something fun and rewarding for us – we do look forward to a cure for cancer, among other things, and want to be part of that.