MALARIA DENGUE TB PLAY SECOND FIDDLE TO COVID-19
Although India has worked relentlessly towards developing innovative testing solutions for COVID-19 throughout last year, the timely detection of a number of other infectious diseases has been sidelined. In India, the range and burden of infectious diseases such as tuberculosis, malaria, filariasis, leprosy, HIV infection, typhoid, hepatitis etc., are enormous. In fact, inadequate containment of the vector has resulted in recurrent outbreaks of dengue fever and re-emergence of chikungunya virus disease and typhus fever. If India can develop more than 20 different diagnostic tests or devices in a single year to fight COVID-19, many more such innovations can be brought to effectively detect other infections looming in our country.
Although India has worked relentlessly towards developing innovative testing solutions for COVID-19 throughout last year, the timely detection of a number of other infectious diseases has been sidelined. In India, the range and burden of infectious diseases such as tuberculosis, malaria, filariasis, leprosy, HIV infection, typhoid, hepatitis etc., are enormous. In fact, inadequate containment of the vector has resulted in recurrent outbreaks of dengue fever and re-emergence of chikungunya virus disease and typhus fever. If India can develop more than 20 different diagnostic tests or devices in a single year to fight COVID-19, many more such innovations can be brought to effectively detect other infections looming in our country.
Like the previous year, 2021 is expected to be dominated by the coronavirus pandemic. Apart from the difficulties it has imposed on the healthcare system, it has made India realise the importance of biomedical resources. It has pushed India to optimise the latent capabilities which the country possesses, across the public and private sector to promote indigenous development and manufacturing.
2020 saw many innovative solutions entering the market within the diagnostic space particularly for COVID-19 testing. A majority of them came from the academic sector, after
receiving timely regulatory approvals and commercialisation.
Although India worked relentlessly towards developing innovative testing solutions for COVID-19 throughout last year, the timely detection of a number of other infectious diseases got sidelined. A recent example is the rise of a rare fungal infection mucormycosis.
In India, the range and burden of infectious diseases are enormous such as tuberculosis, malaria, filariasis, leprosy, HIV infection, typhoid, hepatitis etc. In fact, inadequate containment of the vector has resulted in recurrent outbreaks of dengue fever and reemergence of chikungunya virus disease and typhus fever.
For instance, India is home to approximately 2.8 million tuberculosis patients, making it the largest number in a single country. On the other hand, more than a decade after India eliminated leprosy, the disease continues to linger on. Adding on, India’s malaria surveillance system ranks among the worst in the world according to the World Health Organization (WHO). According to a study published in The Lancet in 2020, diarrheal diseases, tuberculosis and lower respiratory infections were among the leading causes of deaths in India in 2019.
Thus, after witnessing a range of novel diagnostic tests stepping into the market for rapid detection of COVID-19, India should lay focus on developing and commercializing similar point-of-care tests for other infectious diseases
“We are currently funding projects at the AIIMS, THSTI, PGIMER and University of Delhi-South Campus, for developing rapid detection kits for tuberculosis and COVID-19, amid many others.” - DR RENU SWARUP Secretary, Department of Biotechnology, Government of India, New Delhi
“In diagnostics, Indian scientists, engineers, and data experts are rapidly innovating new products that can help humanity to identify and overcome many diseases expeditiously.” - AJIT RANGNEKAR Director General, Research and Innovation Circle of Hyderabad
too, for their timely detection and subsequent elimination. If India can develop more than 20 different diagnostic tests or devices in a single year against COVID-19, many more such innovations can be brought out to effectively detect other infections looming in our country.
Translating ideas in lab
Amidst the ongoing pandemic, the need for devices that can rapidly detect and diagnose infectious bugs is evident within our scientific community. Resultantly, a number of researchers are finding out numerous ways to develop novel, inexpensive and easy-to-use devices to combat these diseases.
A recent example comes from the Indian Institute of Technology, Delhi (IIT-D) where a group of researchers has developed a handheld Surface Enhanced Raman Spectroscopy (SERS) based platform for early diagnosis of dengue virus. It gives dengue test results within one hour. The handheld device has been successfully tested on the clinical blood samples collected from hundreds of individuals in collaboration with the National Institute of Malaria Research (NIMR), New Delhi.
The detection and distinction of human immunodeficiency virus (HIV-1) was also carried out in collaboration with the National AIDS Research Institute (NARI), Pune through the handheld SERS based platform. It gives HIV-1 test results also within an hour. This research work has been funded by IMPRINT India programme of the Ministry of Education with
“Early diagnosis of dengue is the key to prevent deterioration of a patient’s health. However, conventional diagnostic tools like nucleic acid detection using Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a time taking process and it also requires expensive equipment and reagents for the diagnosis of dengue.”
- DR J P SINGH
Professor, Department of Physics, Indian Institute of Technology, Delhi
“High-sensitivity rapid tests for HBsAg are necessary with the effective vaccination programme to eliminate Hepatitis B.” - KIM PETTERSSON Research Director, Molecular Biotechnology and Diagnostics, University of Turku, Finland
“TB is the deadliest infectious disease today and India has the largest number of TB-related deaths among all countries in the world. Through our device, we have tried to address the challenges of affordability, accessibility and user-friendliness.” - DR BHUSHAN TOLEY Assistant Professor, Department of Chemical Engineering, Indian Institute of Science, Bengaluru
“With our malaria detection test, results can be read after 20 minutes from sample addition, with a simple photoluminescence reader. It has potential for diagnostic testing of both symptomatic and asymptomatic individuals.” - DR GAURAV BATRA Assistant Professor, Translational Health Science and Technology Institute, Faridabad
Gurugram-based New Age Instruments and Materials as the industry partner.
“Dengue is a serious global health concern with a large population around the world facing the risk of getting infected. Early diagnosis of dengue is the key to prevent deterioration of a patient’s health. However, conventional diagnostic tools like nucleic acid detection using Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a time taking process and it also requires expensive equipment and reagents for the diagnosis of dengue. Our ultrasensitive and handy device has a wide range of applications in the early-stage on-site detection of viral diseases and can produce the final report of investigation within an hour”, says Dr J P Singh, Professor, Department of Physics, Indian Institute of Technology, Delhi.
Keeping a focus on rapid detection of tuberculosis (TB), engineers at the Indian Institute of Science (IISc) in Bengaluru have designed a low-cost paper-and-plastic device that can detect the presence of TB DNA in liquid samples. An untrained user can perform a TB test by simply adding liquid samples to the paper reaction zones and placing the device in an incubator for 60-80 minutes. The results of the test are read using a cell phone camera installed within a small plastic box. The material cost of fabricating the device is only Rs 61 and the cost of reagents per reaction zone is Rs 41.
“TB is the deadliest infectious disease today and India has the largest number of TB-related deaths among all countries in the world. Through our device, we have tried to address the challenges of affordability, accessibility and user-friendliness. The technology is called Fluorescent Isothermal Paper-and-Plastic Nucleic Acid Amplification Test (FLIPP-NAAT). A pilot clinical trial done in collaboration with Christian Medical College (CMC) Vellore has achieved 100 per cent sensitivity for the detection of TB. Besides its application for the diagnosis of TB, it could be modified to detect other diseases as well”, says Dr Bhushan Toley, Assistant Professor, Department of Chemical Engineering, Indian Institute of Science, Bengaluru.
Adding on, a recent collaborative study between Faridabad-based Translational Health Science and Technology Institute (THSTI) and University of Turku, Finland has led to the development of a highly sensitive and robust point-of-care test that can detect malaria infection. The test has been validated by running samples containing different strains of
Plasmodium falciparum, the causal organism, from different geographical areas.
While microscopy is the historical standard method of malaria diagnosis, rapid diagnostic tests (RDTs) are currently the most popular method of diagnosis in resource-poor areas. RDTs are easier to use than microscopy, do not require skilled workers, and produce results quickly. However, most currently available RDTs do not have sufficient sensitivity to detect asymptomatic or submicroscopic infections.
“Results can be read after 20 minutes from sample addition, with a simple photoluminescence reader. In the absence of a reader device at the testing site, the strips after running the test can be transported and read at a central location with access to a reader. We have found that the test and control line signals are stable for at least 10 months after running the test. It has potential for diagnostic testing of both symptomatic and asymptomatic individuals”, explains Dr Gaurav Batra, Assistant Professor, Translational Health Science and Technology Institute, Faridabad.
A similar collaboration between the scientists of THSTI, the International Centre for Genetic Engineering and Biotechnology (ICGEB), and the University of Turku, Finland has resulted in the development of a highly sensitive rapid testing device for hepatitis B. The team has built a lateral flow immunoassay (LFIA) for hepatitis B Virus surface antigen (HBsAg) utilising up-converting nanoparticle (UCNP) reporter. The assay can use whole blood, serum, or plasma and the results can be read in 30 minutes using a reader device. Scientists plan to use clinical settings, with freshly drawn patient samples, using a batteryoperated reader device feasible for point-of-care use to further evaluate the true performance of the test.
“Detection of hepatitis B Virus surface antigen (HBsAg) is an established method for diagnosing both acute and chronic hepatitis B virus (HBV) infection. In addition to enzyme immunoassays (EIAs), rapid diagnostic tests (RDTs) are available for the detection of HBsAg in resource-poor settings. However, the available RDTs have inadequate sensitivity and therefore are not suitable for diagnosis of patients with low levels of HBsAg and for blood screening. High-sensitivity rapid tests for HBsAg are necessary with the effective vaccination programme to eliminate Hepatitis B”, points out Kim Pettersson, Research Director, Molecular Biotechnology and Diagnostics, University of
“Diagnosing a drug resistant urinary tract infection can take days. The most used method of microbial culture, requires 2-3 days’ time, a laboratory and highly trained manpower. With our test ASTSENSe, the results would be available within 2 hours rather than 2 days.” - SACHIN DUBEY Chief Executive Officer & Co-founder, Module Innovations, Pune
“Bengaluru based SpotSense is working on building a diagnostic pacifier platform for saliva-based screening of various neonatal health ailments including a rapid diagnostic test for neonatal sepsis, and Pune based Module Innovations is developing colour changing nanofiber strips for selective detection of the entero-haemorrhagic bacterial strains, to combat AMR”. - DR TASLIMARIF SAIYED Chief Executive Officer & Director, C-CAMP, Bengaluru
Turku, Finland.
Delving further into the world of microorganisms that are responsible for different parts of the human body, a team of researchers at the National Institute of Ocean Technology (NIOT), Port Blair, has developed a highly effective kit to detect multi drugresistant (MDR) strains of the gram positive bacteria Enterococcus faecalis. This organism is a common cause of morbidity and motility across the world infecting the urinary tract, bloodstream, endocardium, abdomen, biliary tract, burn wounds, and indwelling foreign devices.
Likewise, scientists at the Mohali-based National Agri-Food Biotechnology Institute (NABI) have developed a probe-based assay to detect the presence of Escherichia coli, the most common cause of diarrhoea.
“Despite India’s rapid economic growth and growing technological prowess, it continues to face a heavy burden of infectious diseases. Under our Infectious Disease Biology Programme, currently we are funding projects at the All India Institute of Medical Sciences (AIIMS), Translational Health Science and Technology Institute (THSTI), Postgraduate Institute of Medical Education and Research (PGIMER) and University of Delhi-South Campus, for developing rapid detection kits for tuberculosis and COVID-19, amid many others”, says Dr Renu Swarup, Secretary, Department of Biotechnology,
Government of India, New Delhi.
Even though scientists across the country are being provided with public and private funding opportunities and a comprehensive set of resources to support their discovery, research, pre-clinical development, and clinical evaluation, the important part is to fast-track the entry of these products into the market with suitable industry partnerships.
Startups reinforcing the need
Over the past few years, many biotech and healthcare startups have carved a niche for themselves in the Indian diagnostic market with novel ideas and technologies. India is also home to a number of accelerators and incubators that are nurturing these startups to deliver beyond their capacity.
A common example of such an accelerator for startups is Bengaluru-based Centre for Cellular and Molecular Platforms (C-CAMP) that is currently encouraging startups to develop solutions against antimicrobial resistance (AMR). AMR has become a serious global challenge for public health as bacteria, fungi and viruses are increasingly becoming resistant to antimicrobial drugs that were previously effective against them, making it more difficult to treat infections.
“C-CAMP has recognized the significance of AMR and is working towards fostering and amplifying R&D efforts in this space. C-CAMP startups and individuals currently working
on innovations tackling AMR are under three verticals: Preventatives, Diagnostics and New Drugs. In particular, Bengaluru based SpotSense is working on building a diagnostic pacifier platform for saliva based screening of various neonatal health ailments including a rapid diagnostic test for neonatal sepsis, and Pune based Module Innovations is developing colour changing nanofiber strips for selective detection of the entero-haemorrhagic bacterial strains”, says Dr Taslimarif Saiyed, Chief Executive Officer & Director, C-CAMP, Bengaluru.
On the other hand, another startup associated with C-CAMP, Achira Labs has recently received recognition by US based organization CARB-X, for developing a rapid molecular diagnostic platform for urinary tract related infections. In addition, Module Innovations has received up to $3.2 million funding from CARB-X to develop a rapid and easy urinary tract infection (UTI) diagnostic test giving antibiotic resistance results in two hours.
“UTI is the one of the most common infections in the human body affecting 150 million people globally. While there have been significant advances towards bacterial diagnosis, UTIs largely are still treated on the basis of empirical broad-spectrum antibiotic. This practice fails in many situations when the infectious bacteria are drug resistant. Diagnosing a drug resistant UTI can take days. The most used method of microbial culture, requires
2-3 days’ time, a laboratory and highly trained manpower. With our test ASTSENSe, the results would be available within 2 hours rather than 2 days”, shares Sachin Dubey, Chief Executive Officer & Co-founder, Module Innovations, Pune.
Research and Innovation Circle of Hyderabad (RICH), set-up by Telangana government, has recently started a new accelerator programme for startups in the in vitro diagnostics sector. Mentored by an expert panel of entrepreneurs, scientists, inventors, and innovators; supported by the Centre for Cellular and Molecular Biology (CCMB), Hyderabad, this programme is expected to help startups overcome all hurdles, both conceptual and infrastructural, to realise their full potential in the diagnostics space.
“Innovation in science has demonstrated its ability to transform the world. In diagnostics, Indian scientists, engineers, and data experts are rapidly innovating new products that can help humanity to identify and overcome many diseases expeditiously,” says Ajit Rangnekar, Director General, RICH, Hyderabad.
On the whole, the diagnostic industry in India encompasses a number of established and experienced players that are capable of bringing multiple innovations on the table. But there are certain challenges that have limited the manufacturing potential of the industry all this while.
“In India, the approach to healthcare is transforming from curative to preventive with the concept of preventive healthcare gaining ground. On the manufacturing front, thanks to the introduction of the production linked incentive (PLI) scheme, a large number of manufacturers will be able to bolster their production capacity of diagnostic solutions. This will significantly enhance India’s share in the global diagnostic device exports”, says Dr Veeral Gandhi, Founder & Chairman, Voxtur Bio, Mumbai.
Besides developing affordable and accessible diagnostic solutions, we also need to pay attention to specimen collection. Thus, it is essential to train the healthcare workers in our country on phlebotomy for specimen collection as well as improve our infrastructure to transport specimens to diagnostic centers. These measures are critical in controlling infectious diseases in India.