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Invitae Bets on Oncology Portfolio to Drive Growth as it Streamlines, Integrates Test Services

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NEW YORK – Recently anointed Invitae CEO Ken Knight this week shared his vision for the company after a tumultuous 2022, noting that the company is "doubling down" on its oncology business, aiming to create an end-to-end clinical decision support system.

Knight said that the company is streamlining and combining its somatic and germline testing offerings while advancing the development of its Personalized Cancer Monitoring MRD services in an effort to create a sort of one-stop shop for cancer patients and their healthcare providers. 

"We're allocating the capital that we have as a company to launch and get clinical utility confirmed, to get guideline and physician adoption, and to get reimbursement for our somatic offering, the first one of which is our minimal residual disease product," Knight said.

Knight added that Invitae's somatic and germline offerings were developed by different business units that were largely siloed from each other, leading to disparate consumer experiences.

"They have to be integrated into a single experience for the oncologist, [facilitating] ease of use, ease of ordering, and ease of information flow," he said.

Focusing capital more narrowly into these areas is part of an overall change in Invitae's long-term business plan, driven by a portfolio that had grown overly broad and disconnected, and which contained many nonprofitable elements, Knight said. These factors contributed significantly to the firm's large restructuring effort last summer, including laying off more than 1,000 employees and culminating in December's sale of its Archer portfolio of research-use-only next-generation sequencing kits to Integrated DNA Technologies.

Knight commented that a few small pieces of the company's restructuring, such as some facility consolidations, remain to be done but that the bulk of the restructuring decisions had been executed.

Invitae's overarching goal is to expand the use of genetic testing in oncology, reaching more physicians as well as communities that have more limited access to such testing and to the expertise needed to interpret it. To improve such access, Knight said that non-genetic experts will need to find oncology offerings easier to use.

"Much of the hereditary cancer screening is managed by genetic counselors today," he said. "But less than half of cancer patients who are treated are actually getting hereditary cancer screening because there's not enough genetic counselors to go around."

The new integrated offering, he said, will make adoption easier across the board and may have a particular impact in rural settings, where genetic counselors and other specialists are even more rare.

New digital tools planned for this year may help in this effort by easing access to genetic information in places where a human expert may not be found.

Knight said that it is too early to provide details on these tools, but referenced Invitae's Genetic Information Assistant (GIA) chatbot as an example of the kind of technology being developed to further enhance patient access and clinical decision support.

Despite the renewed emphasis on oncology, not all products under development will immediately receive the same attention and resources as PCM.

Stratafide, a tumor-agnostic test designed to guide therapy for cancer patients and whose path to regulatory clearance had been delayed, remains under development but does not have an estimated timeline to regulatory filing.

"We'll get some clarity [on Stratafide] as 2023 unfolds," Knight said. "Our focus is on our minimal residual disease product, and we will be laying out the kind of path forward for the other stuff as we go through 2023."

The company's push to better reach underserved areas in particular may involve some new hiring, but Knight said that this would not amount to significant personnel increases.

"Our first question is, do we have the talent inside, even if it means being reallocated from something else," he said.

The company will also continue to invest in other areas, such as its pharmacogenomics products. Knight said these tests have numerous oncology applications, but that the company is also working on applications such as rare disease and heart disease.

Finally, Knight described Invitae's patient data and patient network as other long-term growth drivers. The company currently has genomic data from over 2 million patients available for use, which it can, in many cases, link to real world outcomes.

"You put all that together and you have a more useful data set for patient advocacy groups, as well as for biopharma researchers who are trying to do drug discovery," Knight said. "That business, we believe, has long-term value generation."

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