COVID-19 pandemic has brought about the most unprecedented global health and socio-economic crisis. To assess the severity and progression of COVID-19 – testing, tracking, and tracing (TTT) strategy is widely adopted across the world. Responding to this sudden increase in the demand for COVID-19 testing globally, many in vitro diagnostics (IVD) companies are coming up with new tests for rapid and accurate diagnosis of this disease. The clinical testing laboratories are also trying to meet the growing demand for COVID-19 testing.
Unfortunately, the number of cases in India is rising at present. The government has taken measures for improving access to COVID-19 tests across the country. The laboratories in India have responded by making strategic investments to improve the scale of testing. They have also focused on the quality of testing by sourcing tests with high sensitivity and specificity.
Pune-based GenePath Dx is a leading diagnostics company and clinical testing laboratory company, which has emerged as one of the leading COVID-19 testing centres in India. It was also the first organization in India to receive regulatory approval from the government, for both clinical testings of COVID-19 as well as for their own COVID-19 qRT-PCR test kits.
Gautami Kundan, Research Analyst at AcuBiz Consulting Sdn. Bhd discussed with Dr. Nikhil Phadke, Founder and Chief Scientific Officer of GenePath Dx about the emerging market trends in the COVID-19 diagnostics segment in India and GenePath Dx’s business strategies for balancing the required investments and meeting the rising demand for COVID-19 testing.
GK, AcuBiz: GenePath Dx is emerging as one of the leading COVID-19 testing centres in India. Could you please give us a brief overview of the company? For instance, how and when did you start GenePath Dx? What are the focus areas of GenePath?
Dr. Nikhil Phadke: I come from a family of doctors, all four of my grandparents as well as my father, were doctors. However, I was interested in science and engineering as well. So, I decided to pursue a path that would involve an intersection of all these areas. This led me to pursue a Ph.D. in Molecular and Cellular Biology.
In the late 90’s, when I was in graduate school at the University of Michigan in Ann Arbor, I had my first experience with genomics, proteomics, and bioinformatics. After graduate school, I got together with some of my colleagues who had just founded a spin-out company from the University of Michigan called HandyLab. HandyLab was a highly successful microfluidics-based molecular diagnostics start-up. The HandyLab journey was an interesting and rewarding one, which culminated with an exit to Becton Dickinson. We are thrilled that the product we designed at HandyLab continues to be sold and used around the world, even for COVID-19, under the brand name BD Max.
After the HandyLab experience, I decided to come back to India and set up something on my own. This is how I founded GenePath in 2008. GenePath is headquartered and incorporated in the USA. We have a state-of-the-art lab and R&D facility in Pune, India, and another facility in Ann Arbor, Michigan, USA.
The goal of GenePath is to work in all the areas of modern diagnostics. Initially, we started with DNA and RNA-based diagnostics. Therapeutic segments wise we have three broad areas of focus: Infectious diseases (including COVID-19), Oncology and Genetic disorders.
GK, AcuBiz: Please give an overview of GenePath’s activities in the IVD market.
Dr. Nikhil Phadke: Initially, GenePath was established as a service lab offering a large portfolio of tests. We started with DNA and RNA tests for endocrinology, nephrology, hematology, oncology, and infectious diseases. GenePath Diagnostics also builds its own in vitro molecular diagnostic and genetic and genomic testing kits. We develop assays for infectious diseases, oncology treatment, and genetic disorders and also offer clinical diagnostics services for these for the Indian market.
With respect to our service portfolio, we currently offer over 250 diagnostic tests from our clinical laboratory in Pune. In terms of diagnostics, we have a deep pipeline of diagnostic products. Our SARS-CoV-2 PCR kits are approved by ICMR in India. In the USA, they are being used by our partner laboratory LynxDx in Ann Arbor, MI in their CLIA laboratory following CLIA-EUA notification. We have also developed tests for several other infectious diseases such as CMV, Chikungunya, Dengue, and Zika which are in various stages of the regulatory process.
GenePath has also built some novel sample preparation products for the infectious disease molecular testing market that will be introduced over the next few months. On the genetics and genomics front, GenePath has developed a revolutionary patent-pending platform for high throughput detection of SNVs, CNVs, and methylation aberrations known as CODE-SEQ. This platform has been evaluated by a European Nation for the screening of their entire population for the degenerative neuro-muscular disorder – Spinal Muscular Atrophy (SMA). This platform is being extended to a genetic screening of other disorders like Alpha and Beta Thalassemia, Congenital Adrenal Hyperplasia (CAH), Cystic Fibrosis (CF), etc.
GK, AcuBiz: Why did you decide to add COVID-19 tests within your product portfolio?
Dr. Nikhil Phadke: When COVID-19 hit, we were already working on other infectious diseases. We have a lot of experience in designing tests, which we gained from our past start-up Handylab and currently GenePath. We also have an extensive network of collaborators with relevant experience. Hence, we were in a position to develop a really good test. Additionally, we were in the position to start testing as well.
In a way, GenePath is kind of unique because we are a testing lab as well as a kit developer. So, we provide both testing services and also develop the test kits for COVID-19 testing. We have a drive-through facility along with home collections of samples. We also do corporate screenings on-site.
GK, AcuBiz: What are the COVID-19 tests offered by GenePath Dx? Are there more in the pipeline? Has GenePath partnered with any other company to meet the increase in demand for COVID-19 testing?
Dr. Nikhil Phadke: GenePath Diagnostics offers a qRT-PCR test which is used for the detection of SARS-CoV-2 RNA from respiratory samples. The test kits have been approved by ICMR.
Currently, we are developing some rapid tests for COVID-19 testing. Our goal is to develop a kit that is as sensitive as PCR, viable, durable, and cheap. We expect the test to be out in October.
Regarding our partnerships, we work with a company in Bangalore known as Achira Labs. Our testing services are limited only to Pune and Bangalore. We are working across the entire Pune. And as mentioned earlier, we have partnered with a US-based company LynxDx where our qRT-PCR test kits are being used.
GK, AcuBiz: India seems to be standing at 3rd position in the world in terms of the number of cases. What are your views on the current COVID-19 pandemic situation in India?
Dr. Nikhil Phadke: I think that it is peaking right now in the Mumbai-Pune region of Maharashtra and will reduce moving forward. This appears to be happening in waves across the world. Different places peak at different times. In the USA for example, New York had the highest number of cases in March-April but now most of their hospitals are empty. So, if look at the bigger picture and look across time, we can see that different places are peaking at different time. In India, Maharashtra had peaked first. I think this wave will reach a certain amount of herd immunity in the population and from then on, the rate of infection will start declining.
And of course, there is the hope that a vaccine will be available in the next 6-8 months. Though the vaccine is never going to be 100% effective, even 60-70% effective vaccine will be a significant milestone. The combination of vaccines, social distancing measures, and herd immunity together can help a lot. However, it would be a new normal and we may not go back to the same life we had 6 months back.
In terms of the measures, which India has undertaken for controlling this virus, I think we are still under testing. Resources are not sufficient in the country. The high cost of these tests is another major concern. Testing needs to be increased much more, though comparatively, we are doing better now.
GK, AcuBiz: Are Indian IVD companies able to meet the demand for COVID-19 testing in India? Indian market currently has many suppliers from abroad offering COVID-19 diagnostics kits. Who are the leading suppliers in India?
Dr. Nikhil Phadke: There is an increase in demand for COVID-19 testing as the number of cases is increasing. Domestic companies are unable to meet demand. Most companies are buying test kits from abroad.
USA-based Thermo Fisher Scientific and South Korea’s Seegene are currently the leading suppliers for COVID-19 test kits in India. Many other Korean companies are active in the Indian market. Another South Korean company, SD Biosensor, seems to have a significant market share in India since they offer PCR, rapid antigen as well as rapid antibody test kits. The test kits provided by the French company BioMerieux are also being used all over India.
GK, AcuBiz: What is the testing capacity of GenePath for qRT-PCR tests? What challenges did you face throughout the process of COVID-19 testing?
Dr. Nikhil Phadke: On average, we carry out about 500 tests per day. For analysis, it takes about 4-5 hours per sample. So, the testing of a batch of samples is completed within 5 hours, but the process of reporting to the government takes an additional 6-7 hours.
The biggest challenges for us are the data entry and reporting to the government authorities. The reporting burden is significantly higher than the burden of actual testing in terms of resources used.
GK, AcuBiz: With all Rapid antigen and antibody tests coming up, will the demand for PCR test for COVID-19 decrease in the next few months? What are your views on the sensitivity of rapid antigen and antibody tests?
Dr. Nikhil Phadke: I think the demand growth for PCR tests will decrease since its cost is a major concern. However, it will continue to have strong demand as it is more sensitive compared to the rapid tests. So, it is our challenge to come up with rapid tests that are as sensitive as the PCR test.
The rapid antigen tests have low sensitivity, which is anywhere between 40-60%.
GK, AcuBiz: What are your future plans for GenePath – in general, and also from the COVID-19 perspective?
Dr. Nikhil Phadke: With respect to COVID-19, we are working on different means of sampling. That is, sample types other than swabs. We are trying to develop kits that are viable, durable, and cheap and also, which can give the results in 30-40 minutes.
Now, there are several other diseases, especially in the monsoon that have similar presentations like that of COVID-19. If somebody gets a fever and has body ache, we don’t know whether it is COVID, dengue, malaria, chikungunya, or H1N1. So, we are trying to come up with panels and solutions that allow all these conditions with overlapping presentations to be screened for in parallel without a significant increase in cost.
GK, AcuBiz: What initiatives are being taken by the Government of India and Maharashtra to combat COVID-19?
Dr. Nikhil Phadke: The Government of India is taking efforts to increase the testing for COVID-19 by doing antigen testing at sites. Epidemiological surveillance is being done by using a rapid antibody test. Maharashtra government has provided free health care treatment under its Mahatma Jyotiba Phuke Jan Arogya Yojana (MJPJAY).
The good part is that the government is offering the testing for free. Health insurance coverage is also provided for COVID-19 testing in India.
GK, AcuBiz: What are your views about the demand for COVID-19 testing in the coming months around the world?
Dr. Nikhil Phadke: The demand for COVID-19 testing is going to increase globally, in the coming months. The wave is still progressing throughout the world. I think the APAC region will also continue to witness a huge demand for COVID-19 testing.