Invitae has launched a cancer blood test designed to detect the minimal residual disease left over from solid tumors to help gauge a patient’s risk of recurrence and track their response to treatments.
The company’s Personalized Cancer Monitoring platform includes a set of assays that are tailored to a patient’s particular tumor. The test is tuned to the cancer’s specific genetic markers by collecting blood and tissue samples and conducting whole exome sequencing.
Once that signature is re-identified in later screenings, Invitae’s blood test aims to spot the signs of the cancer’s return before it can be discovered by standard imaging procedures, giving oncologists time to recalibrate their therapy options.
"Relapse risk stratification is a clinical need for many patients undergoing treatment for solid tumors and is best served by up-to-date molecular tools to complement and improve upon the standard of care methods for recurrence detection," Invitae’s chief medical officer, Robert Nussbaum, M.D., said in a statement.
To identify minimal residual disease among the small fragments of tumor DNA circulating in the bloodstream, liquid biopsy tests have to be sensitive enough to detect very low levels of the genetic material. Invitae’s customized assays use the patient’s own tumor as a guide to select between 18 and 50 specific DNA variants and narrow the field for detection.
Invitae is currently studying the use of this pan-cancer approach—which previously received a breakthrough designation from the FDA—with specific studies in lung, breast, head and neck as well as gastrointestinal tumors with plans to launch more trials in the first half of this year. The test is available in the U.S., Canada and Australia.
Those clinical studies will be powered in part by the $1.15 billion it raised last year from investments led by SoftBank subsidiary SB Management. The April 2021 funding, in notes that will come due in 2028, was announced alongside a $200 million cash-and-stock deal to acquire lab sequencing and software developer Genosity, with an eye toward expanding access to Invitae’s personalized cancer tests.
Last month, Invitae reported that its annual revenue grew 65% in 2021 from the year before, topping $460 million and driven by a billable volume of 1.17 million tests. Operating expenses, meanwhile, reached $503.4 million, with 2021’s full-year net loss amounting to $379 million.
However, the company is looking to potentially break even in 2022, projecting revenues of about $640 million with a cash burn rate—including the cost of future acquisitions—landing somewhere between $600 million and $650 million.