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MedGenome Focused on Gene Panels for Diagnostics, WGS for Research

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NEW YORK (GenomeWeb) – MedGenome, a Bangalore, India-based genomics firm that spun out of SciGenom in 2013, has been scaling its next-generation sequencing-based diagnostics business and helping to drive whole-genome sequencing-focused research in India.

Aside from its headquarters in Bangalore, the firm also has offices in San Francisco and Boston, and announced today that it has acquired Foster City, California-based Lifecode Health, giving it access to the cancer molecular diagnostic firm's CLIA-certified and CAP-accredited laboratory in the Bay Area to further expand its offerings in the US.

Kartik Kumaramangalam, chief of global products and services at MedGenome, told GenomeWeb at the Advances in Genome Biology and Technology conference earlier this month that the firm has developed targeted NGS gene panels for oncology, neurology, cardiology, inherited disease, ophthalmology, and autoimmune disorders, and last year began offering Natera's noninvasive prenatal test Panorama.

In total, he said MedGenome offers 275 diagnostic tests that range in price from $350 to $500, including $400 for the Panorama NIPT. It receives test orders from over 200 hospitals in India, he added.

MedGenome is equipped with a fleet of Illumina instruments, including HiSeq 4000 and 2500 machines as well as MiSeq instruments. Last year, it raised $20 million in a Series B financing round.

India has its own regulatory framework for offering sequencing-based diagnostics that is similar to the CLIA framework in the US, Kumaramangalam said, and MedGenome is compliant with that framework, he said.

Clinical sequencing is still a relatively new field in India, he added, but he said there is huge potential for growth. Although MedGenome serves more than 200 hospitals, "in the context of India, that is scratching the surface," Kumaramangalam said.

A number of other firms offer NGS-based diagnostic testing or clinical research services in India, and many of them focus on NGS-based oncology testing.

For instance, Cancer Genetics India, a subsidiary of Cancer Genetics, offers NGS gene panels for several tumor types and is collaborating with Kamineni Hospital in Hyderabad for cervical cancer screening. Mumbai-based Positive Bioscience has partnered with Myriad Genetics to offer its oncology tests. Positive Bioscience also offers NGS-based testing to healthy individuals who want to know their risk of developing a suite of diseases that include cancers, cardiovascular disorders, neurological diseases, and so-called "lifestyle" diseases that include asthma, depression, diabetes, and obesity, among others.

Supratech Micropath, a reference and diagnostic laboratory in the state of Gujarat, offers NGS-based oncology tests as well as preimplantation genetic screening tests.

In addition, a few firms are focused on rare, inherited disease, such as New Delhi-based Lifecode Technologies, which offers an investigational exome test for undiagnosed inherited disease.

Kumaramangalam said that currently, patients pay out of pocket for NGS-based tests, with the exception of some companion diagnostic tests for which pharmaceutical companies will reimburse patients.

As such, costs have been a limiting factor for the adoption of the tests, he said.

Another major hurdle in bringing NGS-based diagnostics to the Indian market has been education, Kumaramangalam said, noting that MedGenome has "hosted town halls and clinical workshops" geared toward physicians about genomic testing. The meetings are often disease-specific and occur on a nearly weekly basis, he added. "A huge portion of our activities is in advocacy and education" and "growing the acceptance of genomics."

So far, he said, the biggest impact has been in the rare diseases realm where the benefits of genomic testing are often very tangible. For instance, he said, in one case a child was having cardiovascular problems, but the cause of them had not been diagnosed. Genomic testing revealed that the girl had a rare genetic disorder that was actually caused by the brain sending a wrong message to her heart. The heart itself was completely functional. "A doctor would have a hard time diagnosing that with the genomic information," Kumaramangalam said. Instead of spending years and lots of money on cardiovascular drugs and treatments that would have been ineffectual, the correct diagnosis can guide the management, he said. Those types of stories have been "transformational," he added.

As clinical genomics begins to take hold in India, Kumaramangalam anticipated that the model would be a combination of centralized and distributed testing. Currently, he said, very few hospitals have NGS capabilities, so the clinical NGS testing that does happen occurs at companies with specific expertise in that area. Going forward, he anticipates that some hospitals will begin to develop capabilities in house, but thinks that outside firms may still help with interpretation. "I think it will be a hybrid model," he said.

MedGenome is also building tools and platforms in the research space. Its flagship product in the research space is the Integrated Genomics Platform, an offering that integrates whole-genome sequencing with phenotypic data to comprehensively analyze patient cohorts. MedGenome has ongoing large-scale studies with collaborators in the fields of diabetes, familial deafness, epilepsy, NIPT, and neurovascular inherited disorder.

It is also building tools specifically geared toward oncology, including OncoMD, an annotated database of cancer alterations, and OncoPept, which includes exome and RNA-sequencing to identify T cell neo-epitopes in patients' tumors.

Kumaramangalam said that MedGenome also plans to develop similar "focused point solutions" for diabetes, cardiovascular disease, and rare disease.

And finally, he added, the firm offers analysis services for customers who already have sequence data.

Because MedGenome's research services have a clinical bent, the majority of its customers in this space are pharmaceutical companies and academic laboratories, Kumaramangalam said.

There is a huge opportunity for large clinical studies focused specifically on Indian populations, he said. India is an interesting country to study genetics because the country is both extremely heterogeneous but also has subgroups that are very genetically homogeneous, he said. "It's an unprecedented opportunity to study human beings," he said.

The Indian population-specific research will also help drive MedGenome's clinical business, enabling more precise and accurate testing, as more accurate data on disease-causing variants and their prevalence and penetrance in the Indian population is discovered.

To further drive these population genomics studies, MedGenome plans to participate in the recently launched GenomeAsia 100K project and will contribute $10 million in funding.

Kumaramangalam said MedGenome's role in the project would primarily be "access to patient cohorts and our ability in understanding the data."

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