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NeoGenomics Preparing for Commercialization of Inivata MRD Test in 2022


This story was updated at the request of NeoGenomics to clarify the market opportunity for the firm's MRD test.

NEW YORK – Nearly five months after the closing of its acquisition of Inivata, NeoGenomics has further solidified its plans to launch its RaDaR tumor-informed pan-cancer assay.

On a conference call to discuss NeoGenomics' third-quarter earnings results, the executive team built on previous statements about its plan to commercialize the test and gain reimbursement in the next year.

The minimal residual disease assay runs on Inivata's Invision liquid biopsy platform and looks at 48 known mutations for minimal residual disease monitoring. So far, based on analytical validation data from Inivata's multiple ongoing trials, the test has shown 95 percent sensitivity and 100 percent specificity in circulating tumor DNA concentration levels as low as 11 parts per million, NeoGenomics CEO Mark Mallon said.

When NeoGenomics acquired Inivata, Mallon said that he knew the RaDaR assay "was special," but in light of the new data coming in from clinical trials, he's "even more convinced that this assay, and our opportunity to deliver for patients, … is in fact unique." By providing "time-sensitive info," clinicians will be able to act much sooner to treat a patient at risk of recurrence of cancer, he said.

He noted that based on the analytical sensitivity data he's seen, the test "may be the most sensitive assay for detection of recurrence," and could detect recurrence "months ahead" of competitors' tests.

Clive Morris, president at Inivata, reiterated that the firm is on track to submit the assay to Medicare Administrative Contractor Palmetto GBA to seek reimbursement through its MolDx pathway at the end of 2021, with the hope to receive coverage and launch the test commercially in mid-2022.

Morris said that the firm has spoken with MolDx administrators and has a "clear view of what we need to be delivering and submitting to get through the path for approval."

Currently, NeoGenomics is planning for multi-tumor or pan-cancer use for the test, he said. It is also pursuing a parallel path for regulatory clearance through the US Food and Drug Administration, he said, although the firm hasn't disclosed any timeline for clearance.

In March, the test received breakthrough device designation from the agency, and late last year Inivata began offering the test at its CLIA-certified, College of American Pathologists-accredited lab in Research Triangle Park, North Carolina.

According to Mallon, successful commercialization of the test will increase NeoGenomics' long-term growth rates "into the high teens." The firm has also seen "strong interest" from multinational biopharmaceutical companies, Mallon said, noting initial collaborations with biopharma clients are progressing into "large, late-stage development program opportunities."

To support the commercial launch of the assay, NeoGenomics is doubling the size of its customer-facing sales team, expanding its precision medicine management team to 50 people, and adding 10 medical science liaisons "to serve medical oncologists who will be the focus of the launch of RaDaR," Mallon said. The larger sales team will help the company "accelerate the market penetration" of the test, he said.

The sales team will also continue to drive uptake of the InVisionFirst-Lung panel for patients with advanced non-small cell lung cancer, he said. Mallon added that NeoGenomics has "started to see an uptick in performance and … accessioning" of the lung cancer test since August.

Mallon added that NeoGenomics is "committed to make the investments necessary to realize the sizable clinical and pharma market opportunities for minimal residual disease and recurrence testing." The firm is also looking at opportunities to build additional data behind RaDaR, he said.

Part of the firm's commercial strategy for RaDaR is to draw on its longstanding relationships in the community hospital space, which Mallon called a "foundation we can build on and leverage" to "help shift the practice of medicine." Having those previously established relationships is "an incredible place to start in a business," he continued. "New players don't have that kind of a starting position."

Despite those established relationships, NeoGenomics is still working to build further rapport with oncologists and educate them on the potential uses of RaDaR so they'll be prepared to order it when it officially launches next year, Mallon said. "There's a tremendous amount of education to get these physicians to be comfortable to start prescribing this new assay when it's available," he said.

The firm wants to "raise their awareness" so it can "build in … demand" before the test launches to "help us get off to a faster start," he said. It's also "about laying the groundwork for what's going to be a [15 billion] dollar opportunity," he said. "You can't get started too soon on laying the foundation to be a success and a leader in that market."

By building on its original network of community oncologists, Mallon said NeoGenomics will be "in the right place at the right time with the right relationship to actually influence what the physician is doing."