Gene Xpert Media Call
Results Education Fund
Moderator: Blair Hinderliter
December 7, 2010
9:00 a.m. CT
Operator: Good morning. My name is (Tamika), and I will be your conference operator today.
At this time, I would like to welcome everyone to the new TB diagnostics conference call. All lines have been placed on mute to prevent any background noise.
After the speakers’ remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star, then the number one, on your telephone keypad. If you would like to withdraw your question, press the pound key. Thank you.
Mr. Blair Hinderliter, you may begin your conference.
Blair Hinderliter: Hello, and thank you for joining today’s media teleconference hosted by Advocacy to Control TB Internationally, the World Health Organization and the Foundation for Innovative and New Diagnostics.
I’m Blair Hinderliter, the Communications Director here at the (Secretary of Action). Before we begin, please note that the information shared today is embargoed until 10:30 am GMT tomorrow, December 8. And now on to today’s exciting announcements.
The World Health Organization today endorsed Xpert MTB/RIF, a new technology that completely changes the public health approach to diagnosing and treating TB, which remains one of the greatest killers on the planet.
Xpert allows TB to be rapidly, safely and accurately diagnosed and can detect many cases that are missed by the current technology, which we know is more than a century old. This includes diagnosing TB in people who are HIV-positive, which the current tool fails to do so. Since over a quarter of all AIDS-related deaths are caused by TB, Xpert is a critical tool in the fight against AIDS.
Xpert also allows for the rapid initial detection of drug-resistant TB, something that previously took two months in a high-tech laboratory now takes two hours in a simple table-top. This technology has the opportunity to dramatically alter the trajectory of the disease in the world’s most hard-hit countries.
A typical TB patient infects 10 to 15 other people in the course of a year. So rapid diagnosis and rapid treatment means halting the disease in its tracks, ushering a phase where we can envision the elimination of the disease.
And now I’d like to turn the call over to Dr. Mario Raviglione, Director of the WHO Stop TB department.
Thank you, Mario.
Mario Raviglione (Director, Stop TB Department, WHO):
Thank you very much. Today, the World Health Organization has endorsed, for use by all countries in the world, a new rapid TB test. It is a fully automated, molecular DNA-based test, that can diagnosis tuberculosis and the most difficult forms of tuberculosis within 100 minutes, one hour 40 minutes These include the most difficult forms of tuberculosis being diagnosed today, meaning the ones that are smear negative, meaning the ones that you cannot see the bacteria in the microscope. This is commonly related to HIV.
The test, that is called Xpert, will transform our thinking and revolutionize the way we handle TB care and control. And so, what we have done for today is to prepare and to promote a roadmap for countries to help them and to support them in the adoption and in the implementation of this particular test.
It’s basically a development that the world has been waiting for, for literally decades. It’s something that has the potential of truly revolutionizing the way we deal with TB today.
Now, how did we (WHO) work? I’m going to give you some generalities and then (Michael Leeks) will go more into detail. How did WHO essentially work on this new test that collects scientific evidence and then launch it?
Well, in early September, after months of following up with our partners on the developments around the test, we called an expert committee that systematically reviewed all the evidence that is available, published and unpublished.
Three weeks later, in late September, we convened our strategic body that meets once a year to review the evidence once more and to give us recommendations on different aspects of the adoption and the implementation. And last week we actually convened this consultation, which was attended by some 100 people representing some 15 or so countries. Including, developing countries worldwide, and many of the partners, stakeholders and investors in TB.
We looked at the operational aspects of implementation, and we came up with different types of solutions to the various challenges. So basically what we are doing now is recommending that this new technology be used in all countries of the world. Interestingly enough, this test would be introduced at the same time, essentially, in developing countries as in the rich ones, which is, per se, an evolution when you think that the vast majority of new technology that is developed in the north of the world gets down to the south 10 years later. So here we have basically bypassed this step of the past, with going straight to developing countries.
So now, I believe Dr. Karin Weyer will be telling you more, in detail, what the test is all about.
Dr. Karin Weyer (Coordinator, TB Diagnostics and Laboratory Strengthening, Stop TB Department, WHO):
Thank you, Mario.
Good morning, everyone. As we just heard, this is truly a ground-breaking new test, bringing state-of-the art science now to the health service. This tool is an automated tool, which means it’s done outside of conventional TB laboratories. It’s completely safe, because it’s done within a closed system, so one doesn’t need the expensive bio-safety infrastructure that we need for conventional TB testing. The training is minimal. It can be done by a health worker. It doesn’t need a specially trained laboratory technician.
Taking all of this into account, in the roadmap that Mario has just mentioned, we have last week also discussed and agreed on testing strategies, diagnostic algorithms, to make sure that the test is used in the best possible way and reaching those patients most in need.
Two groups of patients that are specifically targeted for this test are the drug-resistant TB patients, where we expect to see up to a three-fold increase in the number of drug-resistant TB cases to be diagnosed. And the second group of patients, which is highly relevant, for example for Africa, is the group of HIV patients that also have TB. And in this group, we can expect at least a doubling of the number of cases that would be detected by the Xpert once it’s fully implemented.
Thank you. I’ll hand over to Giorgio Roscigno.
Giorgio Roscigno (CEO, The Foundation for New and Innovative Diagnostics (FIND)):
Yes, good morning, everybody. My name is Giorgio Roscigno, and I am the CEO of FIND, the Foundation for Innovative New Diagnostic tests in Geneva. FIND is the PDP, what is called the product development partnership, not-for-profit organization, that has been working on developing new diagnostic tests for poverty-related diseases. TB has been our main area of focus.
FIND has been investing in developing this technology for the last five years, together with our partner, the commercial organization that manufacturers this specific product. And we have been able to develop this specific test for tuberculosis, which has been both validated and evaluated, first in clinical trial, then demonstrated in much larger clinical trials in more than seven countries of the world. We then submitted all this evidence to the World Health Organization, and here we are today with the endorsement of the World Health Organization based on fine data, but also based on other published and other investigators data.
We are very proud to announce today in fact that in exchange for the leverage of our investment and development of their technology, we have been able to negotiate with the manufacturer, a 75 percent reduction of the price versus the cut in commercial price in an established economy.
Now this is a very important point for us, because this is the starting point, but we have also negotiated a further price reduction based on volumes. We have the milestones about when this volume was going to be achieved, and we have a final target (price) that would be very appealing for countries, it would be much cheaper, much more cost effective than what is currently being done today. .
The technology is very easy to perform, as Mio said, which can be a very important thing in Europe, and in the United States, and many high endemic countries, even though it’s still pending.
Two other important features that I would like to highlight is that these technologies that drew platform in respect to the fact that we can perform, are possible to use for a large number of pathogens, we just need to change the reagents. By using the same instrument, you can in fact detect other pathogens in many of these poverty related diseases.
And the other important thing, is that it can be used in the decentralized areas, far from established laboratories.
FIND will continue to work together with the (W chop), particular (W chop GLI), and (GDF) in rolling out these technologies as we have done already in a massive successful program, which is called Expel TB. At this point in time, I would like to close my notes by expressing my thanks to the (inaudible) foundation that has been funding much of the development activity associated with this technology, they invest the (inaudible) of New Jersey that’s been our very strong technical partners. Of course the (NIH), which is also investing in development of this technology, and last they also do the manufacturing which is (inaudible) from the U.S., which has been a really good partner from the beginning all the way until now.
Thank you very much.
Blair Hinderliter: Thank you very much, Dr. Roscigno. I’d like to thank all of our speakers today from the WHO, and FIND, unfortunately the National TB manager from South Africa has been unable to join us this morning. But perhaps if you have follow-up questions for them, we can forward those along, or get you in touch.
So as we heard today, expert is one of the most significant and important public health breakthroughs for TB in half a century. Now it’s essential for donor governments like the U.S. to provide the financial and technical support to help introduce and take the scale of the use of expert in countries with the highest burdens of TB and (TB HIV). And it is absolutely critical that efforts be made to continue to drive down the cost of the test, so it becomes more accessible for all countries to use at scale.
And before we move on to questions, I would just like to restate that today’s information is all embargoed until tomorrow, December 8th at 10:30 am (Greenich) mean time.
OK, (Tamika), if you could once again give instructions on how to ask a question, we’ll move on to Q&A.
Operator: At this time, I would like to remind everyone, in order to ask a question, please press star then the number one on your telephone keypad. We’ll pause for just a moment to compile the Q&A roster.
Male: OK, and, operator, if we could please take the first question.
Operator: Your first question comes from the line of (Kate Belling).
(Kate Kelland): Hello. It’s (Kate Kelland) at Reuters here. I would be interested to find out a little bit more on the price - about the price of this test. You say that it’s critical that all efforts be made to continue to drive it down. And also that - the target - the final target price for developing countries will be about 75 percent discounted to that in developing nations. Could you give us a broad idea of what the price is going to be? Is it going to be $5 or 50?
Giorgio Roscigno: Yes, thank you very much for this question. So let me start telling you how much the commercial price is. So that is 50 euros per (test), 50 euros per cartridge, which is the equivalent of around $65 or $67, depending on the exchange rate with the euro.
But anyhow ...
(Kate Belling): Yes, thank you.
Giorgio Roscigno: ... so what would be the entry price at this moment for the public sector in low and middle income countries is going to be 16 U.S. dollars point 86 per cartridge, which represents a 75 percent rebate over the current sales price in established economies.
That would be the entry price. We have been able to ...
(Kate Belling): Right.
Giorgio Roscigno: ... negotiate and agreed with the company that the price will be function of volumes, because this price has been established between FIND and our partners (Siphiad) based on the cost of goods. So it is obvious that as more volumes have produced, that lower their cost of goods would go. So we have already established, and we believe that it might be already achievable that when we reach the next target volume of 1.7 million cartridges next year, the price will be decreased to $14 per (test) - per cartridge, $14 ...
(Kate Belling): Fourteen - sorry - 14.
Giorgio Roscigno: Yes, 14
(Kate Belling): So that’s when you have orders for 1.7 million?
Giorgio Roscigno: Right. And then as soon as we will be exceeding the 3.5 million cartridges, we expect that the unit cost will be still, going up to $10.7 per cartridge.
(Kate Belling): Right, OK. And to the ...
Giorgio Roscigno: Did I answer your question?
(Kate Belling): Yes, can I ask a follow-up, or ...
Giorgio Roscigno: Please.
(Kate Belling): Could you give me an idea now of which of the first countries have - which countries have indicated that they would like to buy it at this current entry price. Have you got some firm commitments from - have you got some orders coming in from countries that want to start using it right now?
Giorgio Roscigno: Yes. Well South Africa is already using this technology in the private sector for a couple of months.
India is also using - they started using in the private and in the public sector. Pakistan has already started using it in the private sector, through some private not for profit hospitals.
The rollout plan that whatever physicians are launching is there complement of the road map, that has been also communicated today. you can see that the majority of the volumes that we will expect in the next one or two years would be coming from…
(Audio gap)
Operator: Ladies and gentlemen, this is the operator. I apologize but there has been a slight delay in today’s conference call. Please hold and the conference will resume momentarily.
Operator: OK, presenters, you may resume.
Giorgio Roscigno: this is Dr. Giorgio Roscigno again. I think I have answered your questions, unless you want me to repeat some of the things that might have been lost during the interruption.
Operator: Again, to ask a question, please press star, one at this time.
OK. You do have a follow-up from the line of (Kate Kelland).
(Kate Kelland): Thank you. It was - the question - sorry if it’s been answered already, but I didn’t hear it. It was - you were just about to tell me where the majority of the volumes for the first rollout of this test were going to be coming from. You said that South Africa, and Pakistan, and India are using it in the private sector. I just wondered which countries we’re looking at rolling it out in the public sector now.
Giorgio Roscigno: Yes. So there’s quite large number of countries that are interested to start rolling out in the (public sector) . In Africa, certainly Uganda, Ethiopia, Lesotho would be up there. And as we talk about the funding mechanism or where the majority of the funding is likely to come from, we believe that PEPFAR certainly, the president’s initiative, would be supporting, as they are supporting (TB control and MDR to because the tax on in) many countries. They would certainly be supporting this initiative, as will the (TB Reach), which is an initiative of the (Stop TB Partnership), that would include new diagnostic technologies within the funding program.
(TB Care), which is the new USAID project, also, we expect also that this new technology would be included under (backs fund TB program), which is an initiative that is currently rolling out (TB) technologies in 27 high endemic countries all over the world. In addition to the world bank, that also has a very strong commitment in strengthening laboratories especially in the eastern African region at this point in time and hopefully, as the next round of the global fund would be called as round 11, there might be hopefully more countries that will request the introduction of these technology through that channel.
Does it answer your question now?
Female: It does. Thank you.
Operator: And to ask a question, please press star one at this time.
Male: All right. Well, if there are no other questions, I appreciate everyone’s time for joining the call today and I want to thank the speakers once more. If any of the reporters on the call have any follow up questions, please feel free to e-mail me. My e-mail address was in the media advisory or you can call me at 1-702-415-0642, again that’s 1-702-415-0642. Thank you very much.
Operator: Thank you for participating in today’s conference call. You may now disconnect.
END
Posted 1 year, 5 months, 2 weeks, 10 hours, 48 minutes ago
