Today, Biotechnology has changed the face of healthcare innovation. While in early 2000’s large pharma companies were the hub for traditional research and development initiatives, today, with the inclusion of diverse sciences such as genomics, recombinant gene techniques, applied immunology, and diagnostic tests, biotechnology represents a new era for the rapid development of new medicines including biologics. Globally, this market has been driven by increased research and development expenditures combined with macroeconomic and demographic trends.
Biopharmaceuticals is one of the fastest growing segment and accounts for the largest share of the Indian biotechnology industry at 58 percent, with its growth being fuelled by the efforts towards the development of personalized medicines, novel therapeutics for COVID-19, cancer, and other disorders, accurate and reliable diagnostic tools for several conditions, R&D around novel large-molecule drugs for diabetes, cardiovascular disease, oncology, and anti-inflammation applications and more. Also playing a key role in drug discovery and development is Bioinformatics although it constitutes about two percent of the total biotechnology revenues since modern biological research is dependent on analysis of substantial amounts of data.
The need for bioinformatics tools and expertise has also increased since genome sequencing projects have resulted in the exponential growth of sequence databases. Today, Next Generation Sequencing (NGS) technologies have gained momentum and they play a vital role in the overall biotechnology sector directing development of advanced diagnostic kits, detecting mutations in clinical situations and in research efforts to develop therapeutics for diseases such as cancer, neurological and prenatal disorders. Diagnostic tests developed for different therapeutic areas are now gaining more importance as effective screening tools to identify the disorders at an early stage helping in research for targeted therapeutics as well as a defining an individual specific treatment regime. With the sequencing based genetic tests still being in its nascent stage in India around eight years ago, Bangalore based MedGenome Labs was quick enough to cash on this opportunity.
Established in 2013, MedGenome Labs was set up with the vision to leverage Next Generation Sequencing (NGS) technologies to provide genetic diagnostics for the Indian market as well as to enable Global Pharmaceutical companies discover new drug targets. Brainchild of Sam Santhosh and Mahesh Pratapneni, MedGenome is a pioneer in clinical genetic diagnostics in India and is one of the highest throughput NGS sequencing labs in South Asia. Today, MedGenome Labs possesses a state-of-the-art Next generation Sequencing (NGS) facility which houses cutting-edge genome sequencing platforms such as Illumina’s NovaSeq, HiSeq X, HiSeq 4000 and 2500, MiSeq and more.
Its sequencing facility is supported by a sophisticated IHC pathology lab and modern molecular techniques such as FISH, PCR, Sanger Sequencing, and Microarray to offer comprehensive diagnostic solutions to researchers, doctors, and hospitals. While Sam Santhosh and Mahesh Pratapneni have been successful entrepreneurs in the software industry, it is their belief in the power of genomics to change the process of disease management in India which has provided a strong strategic direction to the company.
From Striving to Thriving
The core philosophy of MedGenome since its inception has been - ‘Improving human health through precision medicine’. Taking note of India’s disease burden in the key disease areas, MedGenome started its journey with dedicated focus on three categories - Oncology, Inherited disorders and Reproductive Health. While most companies in this domain sent samples for sequencing out of the country, MedGenome focused on equipping its lab in India with the latest technology and analysis capabilities to sequence and interpret the results at the same accuracy levels as many other countries in the world. Gradually MedGenome expanded its offerings to autoimmune disorders and infectious diseases with the first of its kind SPIT-SEQ test for Tuberculosis and has recently launched its personal genomics division offering Kardiogen test for coronary heart disease.
“Our commitment towards improving healthcare also prompted us to leverage our diagnostics and research expertise to make Covid testing accessible to as many people as possible across the country and providing insights into the virus variants through genomic surveillance initiatives as the Covid-19 pandemic hit the world. Although the journey has not been very easy as clinician acceptance was a crucial part of the business, we remained focused on our goal of educating the
prescriber community while overcoming the operational challenges. Along the way there were others who believed in our vision and wanted to support our efforts and as you can see, today, we are the most heavily funded player in this domain in India,” speaks Dr. Vedam Ramprasad, CEO, MedGenome Labs.
Taking note of the Indian market and its dynamics, MedGenome chose the strategy of developing tests that were essential. With over a million children in India being born every year with serious genetic diseases which cannot be diagnosed by other means, sequencing all the genes (exome sequencing) was the only way to find out what went wrong and help the parents plan for the next child. Hence, the firm launched the exome sequencing test which was rapidly adopted by pediatricians across India and provided a strong base for the company’s growth. The next major requirement was in reproductive genetics where high-risk pregnancies could result in babies with chromosomal abnormalities like Down’s Syndrome.
With the new sequencing Non-Invasive Prenatal testing (NIPT), the mother’s blood is sufficient to detect the abnormalities in the fetus. Through a Pan-India research study, it could be shown that about 96 percent of amniocentesis could be avoided through NIPT, and MedGenome became the first company in India to provide this test. Subsequently, as the Cancer genetics market also developed with the availability of more advanced biologics in the Indian market, MedGenome expanded its offerings to cover this market and launched the liquid biopsy test for lung cancer which was also the first home developed liquid biopsy test in India. These steps enabled MedGenome not only to create the market but also establish leadership in this domain.
Offering a Gamut of Quality Testing
MedGenome’s diagnostics business currently has over 1300 genetic tests which are marketed through five divisions - Actia: For Inherited diseases, Claria: Reproductive Genetics, Prima: Oncology, Micra: Infectious diseases, Genessense: Personal Genomics. The entire range of tests offered by MedGenome is accredited by CAP (College of American Pathologists) which comes with a biannual proficiency testing of all processes of sample testing end-to-end including complete laboratory work, bioinformatic analysis and data interpretation.
The firm also participates in many External Quality Assurance (EQAS) programs. Each assay is run with appropriate standards without compromise of quality at any stage and MedGenome leaves no stone unturned when it comes to taking quality control measures at every stage of the testing process including sample accessioning, DNA/RNA extraction, library preparation, NGS reaction, raw data metrics, bioinformatic analysis, genome analysis and clinical reporting. MedGenome is the only lab where every clinical report being generated undergoes three levels of scrutinization and verification. International standards and recommendations of genetic reporting are followed.
“Genetic testing in the clinical space has been a very doctor centric business in India, market needs include expectations from both the doctors as well as the end customers. These reports need significant help in understanding and the further course of action based on the results can have a big impact on life of the patients as well as their immediate families. Most of these tests are once in a lifetime tests and patients expect these tests to provide clear answers and to be of high value in providing the right insights since these are priced higher and in India these tests are not reimbursed by insurance companies. There is also a lot of concern around the quality and the speed and accuracy of reporting. Specially for diseases like cancer, prenatal disorders, infectious diseases in the post-surgery settings, accuracy and turnaround time of the genetic tests are of utmost importance.
In this regard, MedGenome has always been mindful of the expectations and ensure no compromises on the quality. We have strengthened our logistics network to shorten the time taken for samples to reach our lab from all parts of the country. Our latest high end sequencing equipment as well as South Asia specific baseline databases and a strong team of bioinformaticians ensures quick turnaround and accurate reporting. We also have an in-house team of genome analysts to safeguard report quality and we also offer genetic counselling services for ease of interpretation of the reports and to resolve any queries from the clinicians as well as patients. Besides this we are continuously enhancing our test menu to cater to the needs of the patients based on the recommendation of our prescribers, so we are well positioned to manage expectations of both patients as well as clinicians,” shares Dr. Vedam Ramprasad.
The core philosophy of medgenome since its inception has been - 'improving human health through precision medicine'
Charting the Path Ahead
MedGenome Lab’s diagnostics business has steadily grown over the past few years, with the firm having over 60 percent share of the NGS testing market in India. The company has been increasing its geographic footprint across the country with a strong salesforce of more than 100 across India, dedicated to the respective segments. MedGenome has also consciously looked at expanding to neighbouring countries such as Sri Lanka, Bangladesh, Malaysia. “In addition to diagnostics our lab in Foster city, USA focuses on the research efforts and through our tieups with pharmaceutical companies and universities globally we have created a place for ourselves in the genomics field outside of India as well. As a founding member of the GenomeAsia 100K, we are now leading the initiative to sequence 100,000 Genomes in Asia, which will enable us to provide a unique resource of genetic research for the world. Apart from the growth in numbers, the growth in our presence across disease segments, geographies and in the scientific and prescriber community has been phenomenal in the last eight years and we hope to continue with even more vigor as we go ahead,” says Dr. Vedam Ramprasad, CEO.
“India’s alarming disease burden statistics makes it even more imperative to identify and diagnose at the right time”
India’s alarming disease burden statistics makes it even more imperative to identify and diagnose at the right time. The role of molecular or genetic testing to identify or rule out a specific genetic or chromosomal condition is becoming increasingly important for rare disorders, cancer, cardiovascular diseases. As the market leader in Genetic diagnostics in India, MedGenome’s next goal is to make its tests available across India. This will be accomplished through a combination of organic and inorganic growth.
As an independent entity with a mission to create a difference in the way diseases were treated, under their combined leadership and guidance of its co-founders and team of valued industry experts, MedGenome has come a long way in making a difference in the genetic diagnostics space in India. The firm is confident that in addition to the founders, its core team including the CFO, Surajit Chakrabartty, Chief scientist, Dr. Ravi Gupta along with Dr. Ramprasad will continue to inspire and motivate the organization to reach greater heights as MedGenome continues to positively impact hundreds of lives every day.
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