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Invitae Launches Ciitizen Genome Information Management Platform at JPM

NEW YORK – Invitae on Wednesday officially launched its genome management platform, called Ciitizen, at the annual JP Morgan Healthcare Conference.

Speaking at the virtually held meeting, Invitae CEO Sean George said the Ciitizen platform will help the company expedite its longstanding goal of amassing genomic and other information on individuals through their life span and use that data to facilitate early diagnosis, disease monitoring and prevention, and therapy selection.

At the meeting, George also discussed in more detail the company's plans in cancer genomic testing, which Invitae expects will be a key growth driver.

Earlier this week, the San Francisco-headquartered firm also projected a 64 percent year-over-year increase in 2021 revenues to $458 million.

Future of genomic information management

The Ciitizen platform came to Invitae last year through its acquisition of a consumer healthcare technology company, also called Ciitizen. "We couldn't be more excited to effectively be launching this today," George said. "You'll see a lot more of this to come."

For several years now, Invitae has been building its genome information management platform. This part of the business currently comprises between 8 percent and 10 percent of its revenues, but George sees potential for significant growth in the segment as the genomics industry moves away from a siloed test-by-test, disease-by-disease approach and toward greater data sharing and information networks.

In the current system, it is almost impossible, George reflected, to use advanced data analytics and artificial intelligence to make pertinent associations between genomic information, diseases, and outcomes. "We actually only know a fraction of what the entire genome could mean for individuals by way of improving their healthcare and outcomes," he said. "We've always felt that in order to enable the full impact of this human blueprint of life, we would need to build a network of patients and their genomic data and have the ability to incorporate other information to accelerate the flywheel of the test information."

The company's answer to this quandary is Ciitizen, which George described as "an open-ended, multi-sided, patient-owned and controlled data network." Patients can use the platform to access and store their own medical information in one place, but the platform can also fuel research by Invitae's industry partners.

The data in the platform to date has been used by pharmaceutical companies, for example, to identify patients for their clinical trials or discover drug development opportunities. "We expect these kinds of customers to help us grow that business," George said, adding that even some of Invitae's competitors in the diagnostics sector have accessed and analyzed data in the platform. "We believe this is the nature of the type of network that has to be in place to really work and drive us toward genome management in the future."

Invitae hopes the data in the Ciitizen platform will not only be of interest to partners in the healthcare ecosystem but also to players in retail and the tech sector. The company hopes to attract "anybody with a device, anybody that can bring anything to the table to help an individual understand and navigate at a specific point of their healthcare journey," George said.

Karthik Suri, Invitae's chief product and technology officer, added that the firm is working on ways to make it easier for patients to share their electronic health data in the platform. The firm will host a technology day in March to discuss this aspect of its business in more detail.

A comprehensive offering in cancer

During his presentation, George also discussed the company's ambitions to grow its cancer testing business, which Invitae execs detailed in November during its Q3 2021 earnings call. By the end of 2022, Invitae is hoping to launch "the most comprehensive offering" in cancer genomics, according to George, enabling testing for hereditary cancer risk, disease prognosis, minimal residual disease monitoring, and whole-exome sequencing-based therapy selection.

Its competitors, for example Myriad Genetics, also discussed plans to offer a more comprehensive suite of tests to clinicians and cancer patients at the JP Morgan conference.

During the year, Invitae hopes to enhance its germline cancer risk test offerings using transcriptomics to provide additional insights on the pathogenicity of variants. The firm is also planning to offer polygenic risk scores this year for predicting the risk of cancer and other diseases. The healthcare sector is starting to accept these tests in patient care more than they had a decade ago and it's the right time to offer them, in George's view. "You'll see us this year adding those capabilities, disease area by disease area … to help our clients to make decisions for their patients," he added.

Last August, Invitae had to write off a $262.5 million liability because it did not expect to obtain FDA approval of the Stratafide test by March 31, 2022, a regulatory milestone baked into the ArcherDx acquisition. Stratafide identifies genomic alterations associated with treatment response in patients' tissue or blood samples. George explained that COVID-19-related delays at the FDA partly affected review timelines, but also after discussions with the agency, the company decided to break up the different components of the test and submit them one at a time.

He said Invitae plans to launch the Personalized Cancer Monitoring MRD test, which also came to the company through its ArcherDx acquisition, at the beginning of this year. "We expect to have a clear idea of exactly what the reimbursement will be here," George said. "Once we do that, we'll begin full commercialization."

Invitae also announced a collaboration with Pacific Biosciences to develop a production-scale, high-throughput whole-genome sequencing platform leveraging PacBio's HiFi long-read next-generation sequencing. The platform will bolster the company's diagnostic capabilities in the carrier screening, heritable disease, and rare disease space. George added that the platform developed within this collaboration will also generate more genomic data, which will feed directly into its Ciitizen platform and help grow its genome information management business.

Illumina, which previously tried to purchase PacBio and its long-read sequencing technology, this week announced it will release a new product, called "Infinity," which runs on its existing instruments and provides data on genomic regions up to 10 kb in length.

"Illumina moving into long read is an absolute welcome addition to the pile. It's great," George said. "The more people that are chasing improving sequencing and lowering costs … is a great development for us as a whole."

Earlier this week, Invitae also released its preliminary revenue expectations for 2021. The company said it generated revenues of more than $458 million last year, a 64 percent increase compared to $279.6 million in 2020. The company billed for 1.16 million tests, which is a 76 percent increase compared to 659,000 billed tests in 2020.

The number of healthcare providers ordering testing from the company doubled year over year to more than 17,500. Invitae also has 178 active pharma and commercial partnerships, a 68 percent increase compared to 2020, and these deals are growing its data services business, the firm said in a statement. The company estimated its testing business serves more than 2.5 million patients, 62 percent of whom have agreed to share their data.

In afternoon trading on the Nasdaq, Invitae's stock was down nearly 6 percent at $12.06.

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