GeneKey addresses challenges in genomic tests for cancer

The New York Times recently highlighted problems with a molecular diagnostic test developed at Duke University, reporting on the story in a way that seems to cast the whole genomic testing field into doubt. (See “How Bright Promise in Cancer Testing Fell Apart.”)

Patients and their families understandably want to know whether this case undermines GeneKey's approach. We don't think it does, as we will explain. 

Overall, we have to agree with the article. We are seeing the birth of an industry, and it is "the wild west" out there. Even highly reputable people are doing things that are simply wrong. Our advice to consumers: Trust but verify. Reputation alone is simply not enough.

We believe that GeneKey is the best that's out there, and most others who have been a part of our program agree - patients and oncologists alike.  But how can you tell from outside? Here are some principles to guide you:

1) Was the diagnostic test developed by a team that truly understands all aspects of the technology and science? Too often, doctors, cancer biologists and statisticians treat anything outside their expertise as a "black box". They take it on faith that the other experts have got it right.  At GeneKey, we rely on an intimate interaction between biology, statistics and medicine. Our people have cross-disciplinary expertise, not just in one field or another. Before we accept a patient into our program, we talk with the oncologist to ensure that he/she engages with us so that when the results are in, he/she can make an informed judgment based on both the science and medical experience and knowledge about the individual patient. To this end, we will travel anywhere in the country to meet face to face with oncologists.

2) Was the test developed by people whose foremost incentive is to help patients? Often, cancer tests are invented by academic researchers such as those described in the article, whose careers depend on publishing scientific articles. Their immediate motivation is to get published and win tenure - not to develop tests that actually lead to better treatments. If years later the test proves to be useless, there's not much of a penalty imposed on the researchers. These researchers aren't evil; the system sets up incentives that are not aligned with patients'. At GeneKey, our incentives are aligned - it's to defeat cancer, to make sure we give every patient the best shot with the knowledge that we can produce from their tumor samples.  Each tumor is unique, so each of our analyses are unique.

3) Are there vested interests that conflict with the patients'? Has the test developer pumped large sums into equipment, marketing, etc., around only this one test? When errors or problems are pointed out, do they quickly fix them, or do they brush them off? Our approach is a nimble one, constantly taking advantage of the most recent technology as it evolves.  If there's someone out there who is "the best" - who has developed a better mousetrap - we will simply incorporate their tests.  We don't invest in expensive machines or gadgets - we outsource all of our testing - so if something proves to be unhelpful, or becomes obsolete, we can change without worry.  As the standard moves from microarrays, to exome sequencing, to RNASeq and beyond - we will evolve as well.

Our approach is to assume that everything "known" about cancer may be wrong, and to conduct experiments and analyze the data without any preconceived ideas or prejudices. We draw on published studies to corroborate what we find. We are skeptical, but we also believe that navigating the knowledge that we do have, imperfect as it is, offers real promise and hope for patients today.

We hope this framework helps patients and their families assess their options, including GeneKey, critically.