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Israel to Sequence 100K People, Create Genomic Database to Support 'Digital Health'

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NEW YORK (GenomeWeb) – Attempting to establish itself as a world leader in precision medicine and digital health, Israeli earlier this year started a national initiative to develop a genomic and clinical data research platform.

Israel's government plans to spend about NIS 1 billion (currently about $266 million) to support the National Genomic and Personalized Medicine Initiative, which aims to sequence over 100,000 patients' genomes by 2023 in order to improve targeted patient healthcare services. The multi-disciplinary program also aims to begin collaborating with Israeli HMOs and collecting patient samples in early 2019.

According to Ora Dar, a senior expert of the Technological Infrastructure Division at co-organizer Israel Innovation Authority, the original motivation behind the project was to improve digital health technology and infrastructure to benefit the Israeli population.

In addition to the Innovation Authority, the initiative is being spearheaded by leaders from Israel's Prime Minister's Office; the Ministries of Finance, Health, Social Equality, Economy, and Science and Technology; and the Council for Higher Education.

"We just elected a CEO, who should be raising additional funding independently of the governmental effort," Dar said. "While he hasn't been announced yet, we hope he will be announced by the end of the year."

Dar explained that the team will focus on integrating medicine, academia, and industry in order to develop personalized solutions for patients suffering from long-term diseases or illness.

As part of the initiative, Dar said that the team will establish the Mosaic Project, a national database for health researchers working in genetics and medical information. Dar believes that Mosaic will show long-term disease and illness trends of Israeli citizens for the past 20 years. The plan will include a group of volunteers representing Israel's epidemiological and ethnical network who will contribute anonymized clinical and genomic data to the database.  

According to Dar, the group wants to flesh out Mosaic in order to leverage Israel's "competitive advantages," including the country's access to patients' medical data, a diverse genetic population, advanced research activity, and a growing startup environment.

"98 percent of the population is fully covered by electronic medical records, going back 20 years, and most of the population is insured by two big HMOS," Dar highlighted. "We have Israelis, Bedouins, and people who have come from all kinds of faiths and places in the world, and all will be included."

According to Dar, the team will collect volunteers' biological samples — blood, saliva, urine, feces, and other types — during routine hospital visits, which will help build an infrastructure of biological information. Volunteers can also request specific appointments for sample collection. Within Mosaic's database, the team will de-identify the patients' information and perform "next-generation sequencing and additional techniques when applicable."

Researchers wishing to inquire about the participants' genomic data can apply for access to the database. Dar noted that the initiative will establish scientific and ethical committees that will approve research projects and allocate funds for sequencing as a requirement for researchers to gain access, based on the quality of their proposals.

The team then hopes to develop data analysis technologies, especially for personalized treatments in the oncology space, Dar said. However, she noted that the detailed patient sample collection workflow still needs to be validated.

The initiative will develop "protective mechanisms" to access patients' personal information while ensuring privacy through security measures. The group will also partner with Israel's largest HMOs to gather additional patient information.

The multi-faceted team will begin signing agreements with Israeli HMOs in Q1 2019 and commence sample collection by the middle of the year. Dar said. "We hope to see immediate results, as long as we continue to build [upon] information flowing into the [Mosaic] database."

For example, the initiative is collaborating with Maccabi Healthcare Services to use the HMO's digitalized tissue biobank as a resource for research related to the Mosaic Project. According to Dar, the team envisions collecting samples from anywhere between 100,000 to 200,000 participants by 2023.

However, Dar acknowledged that her team will encounter several logistical and regulatory hurdles as part of the initiative. First, she highlighted that the team will need to further invest in data system platforms and in data standardization. In order to apply artificial intelligence to examine patient data, the team will need to curate patient electronic medical records, imaging, and real-time monitoring of samples.

the Precision Medicine Initiative team will also need to improve and expand access for researchers to clinical data, as well as ramp up training and qualification of data scientists.

Finally, Dar acknowledged that the group will need to reduce budget constraints that limit different interested parties' ability to invest in the initiative.

"The solution is based on ethical committees' approval; volunteers' informed consents to share and donate their clinical and genomic data for research; anonymization; [and] cyber security," Dar said. "All these elements are detailed within the procedures to make medical data available for 'secondary' usage, namely for research and not for immediate direct treatment." While Israel aims to start collecting patient samples in 2019, several countries around the world are currently performing their own government-led genomic sequencing initiatives to gather data on patients with rare diseases and cancers.

In the UK, the National Health Service began its 100K Genomes Project in 2012, which aims to sequence the genomes of 100,000 individuals in order to use their genomic information treat and study cancers and other diseases. Expecting to finish the project by the end of 2018, the NHS is beginning to implement diagnostic whole-genome sequencing for patients with rare diseases.

In the US, the National Institutes of Health launched an ongoing effort called the Precision Medicine Initiative in 2015 is planning to sequence over one million patients' genomes and has partnered with several academic and industry groups. The NIH's enrollment program, known as the All of Us Research Program, began enrolling patients nationwide in May.

China has also recently begun its own national genome sequencing project — called the 100K Wellness Pioneer Project — in 2017 to analyze the genomes, metabolomes, proteomes, and clinical symptoms of 100,000 individuals in order to build a database for disease prevention and health management.

All of these initiatives have named multiple corporate partners who are developing specific technologies for the efforts, helping to analyze participant data, or both.

While unable to disclose specific companies involved in the program, Dar highlighted that the team aims to encourage participation from large technology firms with established health research centers in Israel. She noted that the group is also encouraging Israeli-based companies and startups to perform research and development in the digital health sector using the Mosaic genetic database.

"We have more than 500 [Israeli] companies dealing with digital health…. that [is] related to personal data," Dar explained. "Many of the companies we want to work with are tech-related, and some of the companies will develop cyber tech to protect and anonymize the patient data."

In addition, the Precision Medicine Initiative will decide whether to establish an Israeli national center for genetic sequencing of patient samples.

"We most probably will establish a sequencing center based on the potential commitment to sequence 100,000 genomes within [five] years," Dar explained. "This approach is more economic and, according to lessons learned by the UK project, more valid from technological aspects. Details will be available early next year."

According to Dar, Israel seeks to participate in digital health projects being led and funded by international financial institutions, such as the World Bank and the Bank of South America. The team will also present dedicated platforms and grants for collaboration to encourage health organizations to cooperate with existing academic and industry groups.

"The Precision Medicine Initiative will create infrastructure and platforms for developing medical solutions and in-depth analysis of big data," Dar explained. "Thus, start-ups and mature companies specializing in medical devices, pharmaceuticals, medical AI, [and] data science will have access to clinical, genomic, and other (-omic, behavioral) data."

In addition, the Precision Medicine Initiative will offer companies specialized frameworks to collaborate with health organizations, including performing pilot studies within health institutes to validate and evaluate their medical products.  

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