Monday, March 9, 2009

What is the real issue?

So I'm in a meeting of Laboratory Quality and Organisation Committee of the Cancer Genetics club the other day, and we're going over what some other committee has estimated as the price to put on the different steps involved in doing a genetic test. It's very hard to tag each item independently with a number of centimes (including reagents, plasticware, amortisation of the equipment, and the salaries of the staff), and even then you have to remember it's an average price for labs all across the country.
Add up all the steps from when a sample lands in your in-box to sending the result, and, on average, BRCA testing comes out to about twice what Myriad charges to do it in the States*. Looking at my own lab, we calculated that our price was about on par with Myriad or slightly less. The thing is, how expensive the test is depends entirely on the throughput of samples you have and the level of automation you use.
This tedious exercise is in preparation for such testing to enter into the domain of medical analyses that are reimbursed by social security here. Up to now, the work is classed as 'research' and the national cancer institute pays the labs according to their annual output. Codification will transfer financing to a different arm of government.
The upshot is that you'll get paid so much for the test, and if you can do it for less good for you; if it takes you more, you'll go bankrupt. That's not much different than what happens now, but right now as researchers we have access to funding that industry does not. The change will put us into competition with them. The danger is that if the test is very well paid relative to its cost, private industry will take over. And that, in the thinking of the group, is Evil.
All agreed that the proposed payment was too much, and looking around the room, you could see who was from one of the small labs with few patients and little automation - they saw themselves being wiped out of the game right away, being swallowed not so much by industry as by the bigger lab in the next town. A consolidation into major centers that everyone has been trying to avoid.
To keep this diagnostic work in the academic/hospital labs, it was agreed to rely on our collective and collaborative expertise. We're not just doing some labwork, we've got the biological and medical background to know what to do with the different variants we find. Our value is in the analysis.
Fine. I agree completely. But if our value is in the analysis, why should the benchwork not be consolidated into a smaller number of labs, or even be contracted for? I think the answer is that once a test goes into routine production, it is in fact more economical for private enterprise to deal with it, as long as there is no loss in the quality of the work.
What we're really talking about is the fact that our local, semi-academic labs depend on that reliable income to make up the deficit in funding of real research. With grants harder and harder to get, it's the diagnostic arm that allows the research arm to live. And if research were to wither on the vine, we're all in trouble for the future of health care.
Screening for mutations in BRCA1 and BRCA2 is not, after all, the end of the story of hereditary breast cancer risk. It's 17 % of the story, and the rest is research.
* before crying foul, let me state that Myriad's patent on mutation detection for the BRCA genes has been limited in France to concern only the detection of specific mutations known to be present in a given family. De novo analyses are not covered.


EastwoodDC said...

Efficiency is good, but at some point the values of an expert evaluation must also be considered. In my own work it does not require a graduate degree in mathematics for much of what I do (statistical analysis), but when something exceptional comes along that training and expertise is essential. There is good reason for the labs you describe, these "pools of expertise" to be maintained, but it might be hard to justify keeping all the labs open.

My knowledge of the business ofgenetic testing is poor, but are there newer tests and techniques that the smaller labs could take advantage of, replacing the work lost to industry?

sciencegirl said...

I do think it's essential to keep the pool of expertise, and to keep it in contact with the patients we advise. But how and where the benchwork is done needs to be rethought. You can't successfully argue these days that standard blood work needs to be done by an elite research staff - farm out the work and leave the interpretation to the docs. Genetic analysis is heading the same direction. It isn't there yet, but it will be very soon and labs should not be surprised at this evolution.