GeneXpert Edge will allow both diagnosis, treatment to happen the same day: Peter Farrell

We are launching our GeneXpert Edge which allows for a battery-operated system to be taken to the field closer to the patient, which will allow both diagnosis and treatment to happen the same day. In fact our tests will only take 80 minutes.

Shahid Akhter | ETHealthWorld
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Shahid Akhter, editor, ETHealthworld spoke to Peter Farrell, Cepheid, VP-India of Commercial Operations Globally, Sunnyvale, California, to know more about the launch of their latest diagnostic tools in TB and their business plans in India.

Tuberculosis in India
Tuberculosis has high prevalence in India. 26% of the cases of tuberculosis are here in India. There are many people that are affected but most importantly 850,000 people go undetected, or undiagnosed, or wrongly treated each year in India. So, tuberculosis in India is something that is very complicated. It has to do with being able to improve access, improve medications to be able to help eliminate the disease like the government wants to do by 2025.

Overview of Cepheid in diagnostics: India venture
Cepheid is a global molecular diagnostic company. We have manufacturing facilities in California as well as in Sweden. We have commercial offices in all the main countries around the world and in India. In 2008 we first started selling our products into the country. In 2013 we established our office, and we have had a number of accomplishments.

Cepheid in India: Growth curve and business plans
In India, we’ve had tremendous growth. Cepheid has grown 6X the market. Part of the reason why we’ve grown so quickly is our innovation with our product, and when I look at innovation and I think about innovation there are some things that we’ve done. Eight years ago we launched the MTB/RIF cartridge and we are now looking at the next generation of cartridge that we will have in the future, TB Ultra before the approval cycle here in India. We recently announced the GeneXpert Edge, which allows for more testing to be done closer to the patient. The system is battery operated, easy to use, and uses the same cartridges as we have today. And, lastly, one of the things that is most important is drug-resistant infections and we are working on the initial stages of working on a cartridge to be able to detect that.

GeneXpert tests for drug-resistant TB: Cost and reach of the test
Currently we are only detecting rifampicin resistance, and our future technology, our XDR cartridge will be something that will involve multi-drug resistance.

Now, what is going to be cost of GeneXpert to the patient and how do you plan to ensure that these machines reach villages and towns that currently have less existing diagnosis facilities?
Our test cost has been established through a partnership with NGOs, Gates Foundation and CHAI, as well as the Global Fund to initiate where we’ve established an access price for India and other high-burden countries around the world. How we plan to help get the GeneXpert into those places where it needs it most, where the patients live in the villages and the more rural areas, we’ve implemented 45 vans with FIND as well as the Government of India to be able to do testing.

Cepheid’s setting up a manufacturing unit in India
So, our announcement today was really our intention of setting up manufacturing. We’re still going through the process of deciding what that would look like. We will leverage our parent company Danaher and we’ll also investigate other options for us to do manufacturing in country. What this will do is it will provide more access for the patients and the customers by having longer shelf life, being able to reduce inventory costs for our customers, to be able to provide those to the patient.

Now, why have you decided to set up the manufacturing unit within India vs. any other country?
Well, our growth in India has been tremendous. In fact, it’s right now about the last five years been about seven times GDP and so that has been an area as well as the infection rate of TB is highest here in India. So, that’s why it was important for us to help the fight against TB and to be able to eliminate TB by 2025 as the government has planned.

How do you plan to scale your efforts to set up more manufacturing plants in India?
We will look at what our volumes are and how our business continues to grow to determine where the best places are to be able to set up more manufacturing in India. We feel quite comfortable with our initial plan that will get us through the next three to five years.

Your partnership with TB programmes: On the global trends of tuberculosis, you are providing the kit for diagnosis everywhere. So, how do you find it?
Well, TB globally is a problem. In the high-burden developing countries it is more of a problem, and so we have seen access starting to increase. The governments are starting to supply their own tests in their countries after initial instruments being adopted, more tests being done for TB in many different countries. So, that has expanded as well as the detection and the need for better detection and solutions that get closer to the patient. So, we see access, innovation and localisation being really key around the globe for TB testing.

Is it everywhere the same way, the way it is happening in India, the partnership with different groups?
In the developing countries, the high-burden countries it is the same model where we have partners that help establish programs but more and more the governments are starting to take ownership of providing these tests in the country.

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