CHICAGO (GenomeWeb) – For a company that won't be a year old until next month, Shivom has lofty ambitions.
"We have a potential user base of 7.6 billion people," said CSO and Cofounder Axel Schumacher.
"There is an endless list of stakeholders that should be part of the Shivom ecosystem," Schumacher added. "This could be governments, insurers, employers, pharma companies, patients themselves, people who are just interested in managing their health, genomics initiatives, [and] patient support groups."
While no single entity will be able to sequence, process, store, or analyze the genomes of every living person on earth, Germany-based Shivom sees genomics as the basis for a new era of medicine. "In the next five to 10 years, healthcare ecosystems will change dramatically, and most healthcare ecosystems just don't have this on the radar," Schumaker predicted.
"In a few years it will be normal for human beings to be sequenced," he said. Someone will need to store all this data, but not necessarily in one place. For this reason, Shivom is developing a blockchain-based system for decentralized genomic data storage.
"Blockchain really provides a significant improvement and value over a standard, centralized database," Schumacher said. Security is a primary reason. "It's very important that healthcare data cannot be erased or tampered with. This will be much more important in the future when we collect much more data of patients and use this data for developing therapies," he said.
Blockchain also helps with "disintermediation" of sensitive information when connecting patients directly with various service providers. "This will save our healthcare systems a lot of money potentially." Schumacher explained.
The privacy protections that blockchain facilitates help to create trust and make patients more likely to share their data with other parties.
"At Shivom, we go even further. We add to the blockchain what we call a privacy layer that sits on top of the blockchain so that people can be quasi-anonymous, and share their data without being afraid that their data is leaked somewhere into the dark net or hacked," Schumacher said.
Shivom is relying on a distributed model. "That means that there is no single access point for cyber criminals to hack into a database and … download people's data," according to Schumacher, a geneticist and bioinformatician with experience in the pharmaceutical and biotech industries.
He became interested in blockchain after seeing companies he used to work with struggle to find, access, and share high-quality, relevant genomic data. This process has only become more difficult in the wake of new regulatory frameworks, including the European Union's General Data Protection Regulation, Schumacher said.
"Blockchain has several aspects you can leverage to build something completely new that helps the whole healthcare industry," Schumacher said. He spent about a year studying the technology, then wrote an e-book about strategies for applying blockchain to healthcare before launching Shivom in September 2017.
Schumacher said that Shivom wants to provide more than just genomic services. "We are building a precision medicine ecosystem," he said.
Shivom eventually wants to include microbiomics, metabolomics, and other omics technologies in a longitudinal database "to better understand disease development," Schumacher noted. The platform will include artificial intelligence and deep-learning algorithms to process this information and provide useful feedback to patients, clinicians, and researchers alike.
"We cannot only collect this huge mass of data. We also have to do something with it. We have to make it actionable," Schumacher explained.
While the technology really is in the early phases of development and testing, Shivom has been announcing a number of partnerships over the last six months that indicate apparent strong demand for a new approach to genomic data management.
This month, Shivom said it would team with London-based nonprofit eMQT in an effort to sequence the genomes of 1,000 sickle-cell disease patients in sub-Saharan Africa, starting late this year with Nigeria.
eMQT will work with its institutional partners to collect data from 100 sickle-cell patients and store the information on the Shivom platform to provide security and data-sharing capabilities in a proof-of-concept study. If that works, the organizations will expand the database to 1,000 patients and eventually make the data available to the general medical and research communities.
In a deal announced in June, Shivom is collaborating with SingularityNet to combine blockchain technology, AI, and genomics for medical analytics. SingularityNet, which focuses on providing a commercial marketplace for advanced AI technology, indicated that the goal of that partnership is to develop tools to enable AI and other types of analyses on genomics data without researchers having to view an individual's entire genome or medical record.
Shivom's parent company, an entity called Omix Ventures, has a deal with Australian molecular diagnostics firm Genetic Technologies to build and access a global genomic data management platform for cancer diagnostic development. Since inking that deal in March, the two companies extended their partnership into diabetes.
Genetic Technologies is allowing Shivom to use its CLIA-certified lab in Australia. Shivom has a long-term goal of building its own sequencing facilities, according to Schumacher, but for now, the startup is looking to rely on testing partners across the globe.
And in perhaps its biggest undertaking to date, Shivom is teaming with the Indian state of Andhra Pradesh to support the state's plan to build a genomic database of all 50 million of its inhabitants. The goal of this program and others outside the Western world is to bring diversity to precision medicine, which so far has tended to not have enough data on minority populations.
The first project in Andhra Pradesh will be a diabetes study. Data collection could start by the end of August or early September, though some details still need to be finalized, Schumacher said.
Sequencing will be strictly voluntary, so 50 million people is a far-off goal, but even 10 percent of that total would make for one of the largest genomic databases in the world.
"Such a project has, of course, many layers that are completely new to the precision medicine ecosystem," Schumacher said. "It has an education component, because people have to understand what [blockchain] means," he said.
One new concept is the notion of "smart contracts," according to Schumacher, essentially self-executing algorithms. Individuals will be able to set rules for the use of their own data, such as allowing hospitals to access genome reports in emergencies for the purpose of pharmacogenomics. Drug companies could get genomic samples for a fee, Schumacher suggested.
"These are real-time transactions that will be automatically triggered via pre-defined agreements on the blockchain," he said.
"Then, of course, we have to work on the science behind it, on the data security, the genome sequencing itself, on the bioinformatics pipelines, and put everything together and show that we can do this," Schumacher continued. "Long term, we want to have what we call the world genome," with literally hundreds of millions if not billions of sequences.
Whether Shivom or some other entity gets there first, Schumacher is confident that genomic medicine will become ubiquitous in the next few years. "This will be done," he said.
"Now, we have to understand how this will be done, how to develop technologies, bioinformatics pipelines, data-storage solutions, and sequencing infrastructure. We have to work now on it and not wait because it will come quicker than most people expect," Schumacher said.
While Shivom is a for-profit company, Schumacher sees it as a social enterprise, a "zebra" company of sorts, which is why Omix Ventures is in the process of setting up a nonprofit called the Shivom Foundation.
"We want to build an open platform, and get many players involved in the development," Schumacher explained. The foundation will lead future development of the platform and allow other firms, governments, and academic institutions to build their own apps and databases on top of the core system.
"We are not driven by the profit aspect, but by our ideas, by our visions to have a real impact for the greater good of humanity, for healthcare. We want to combine those two things. I think it's possible to do something for the greater good and still be profitable," Schumacher said.
"What we want to build … is an Amazon kind of health marketplace, but instead of buying books or hardware or phones, you can get access to healthcare services and products," Schumacher added. "This is a huge precision medicine marketplace."
Shivom has raised $35 million this year, mostly from venture capitalists, though about 10 percent of the total came from a crowdfunding campaign, essentially a sale of blockchain tokens, according to Schumacher. "People can then use those tokens for the healthcare services in our platform," including sequencing, he said.