SOME BELIEVE THAT LIQUID BIOPSY TECHNOLOGY has the potential to develop into a Holy Grail of cancer diagnostics. Yet progress in this field has been slow. Now a recent lab acquisition may accelerate the development of clinically-useful liquid biopsies.
There is keen interest in how to achieve the noninvasive diagnosis of cancer. Investors have ploughed tens of millions of dollars into companies developing their version of a liquid biopsy. Financial analysts point out that one reason why NeoGenomics acquired Inivata may have been to gain access to Inivata’s ongoing liquid biopsy development program.
NeoGenomics of Fort Myers, Fla., provides cancer genetic testing services and offers an oncology testing menu to doctors worldwide. The company also works with pharma on clinical trials and drug development.
On June 18, Neogenomics announced it had closed its purchase of Inivata, which is based in Cambridge, U.K. It paid $390 million (having earlier invested $25 million in Inivata in 2020). Inivata says it has liquid biopsy platforms at the ready.
“Part of our opportunity [in acquiring Inivata] is the new diagnostics, with next-generation sequencing and liquid biopsy,” stated Mark Mallon, NeoGenomics’ CEO, in an interview with Clinical Omics. “We are particularly enthusiastic about Inivata’s highly sensitive RaDaR assay, targeting the emerging and significant opportunity for minimal residual disease testing.”
Pathologists and clinical laboratory leaders may see NeoGenomics move liquid biopsy assays through U.S. Food and Drug Administration (FDA) clearance and to the market within a couple of years.
Specifically, company leaders and analysts alike believe there is great potential for Inivata’s liquid biopsy assay. The FDA seems to agree. In March, RaDaR received the FDA’s Breakthrough Device Designation. Inivata says RaDaR “allows highly sensitive detection of residual disease and recurrence.”
On its website, Inivata says RaDaR uses a blood draw and enables tracking of 48 genetic variants with “exceptional sensitivity” in detecting circulating tumor DNA.
Bullish on Liquid Biopsy
Neogenomics is bullish on this liquid biopsy technology. “We plan on leveraging our established oncology diagnostics leadership position, human capital, strong pharma and clinical market relationships, and robust balance sheet to accelerate the development of this assay,” Mallon said in a news release.
“The addition of Inivata bolsters our leading market position today and further establishes us as a leader in the rapidly evolving liquid biopsy testing space,” Mallon added. Mallon succeeded Douglas VanOort in April to lead NeoGenomics to what VanOort (now Executive Chairman of the Board of Directors) called “a next level of performance.”
Inivata becomes a new division of NeoGenomics. Other divisions at NeoGenomics address clinical, pharma ,and informatics.
“By leveraging our combined resources, we expect to accelerate the development of our promising RaDaR minimal residual disease assay and accelerate commercialization efforts with biopharma before driving a successful launch in the clinical setting,” said Clive Morris, Inivata Chief Medical Officer, in a news release.
Detects Residual Disease
In a company conference call, Morris noted results from earlier RaDaR research, especially as it relates to discovery of circulating tumor cells in the blood and the potential for precise follow-up treatment of cancer patients, Clinical Omics reported.
“While the published clinical data and high levels of sensitivity for RaDaR are compelling, perhaps the most exciting aspect about RaDaR and minimal residual disease testing in general is the paradigm-shifting impact it can have for patients along their cancer journey,” Morris said.
“In the adjuvant post–surgery setting, RaDaR can potentially be used to help select patients for adjuvant therapy based on the presence of residual circulating tumor DNA in the blood, indicating that the patient has not been cured by the surgery. In the future, the test may also be able to help optimize the dosing or duration of therapy. RaDaR testing can also be used to monitor for disease recurrent for cancer patients in remission,” added Morris, who will report to Mallon under the new arrangement.
Michael Matson, a Needham analyst, told TipRanks he anticipates NeoGenomics will commercialize RaDaR in 2022.
Matson is also bullish about another Inivata liquid biopsy assay—InVisionFirst-Lung—which has been commercially available through NeoGenomics in the U.S. and internationally. It is used, Inivata said, in treatment decisions for people with advanced non-small cell lung cancer (NSCLC). NeoGenomics anticipates InVisionFirst-Lung will generate the lion’s share of the $5 million in Inivata sales in 2021, MedTech Dive reported.
Pathologists and clinical laboratory executives should consider it significant that NeoGenomics was willing to invest $390 million to acquire Inivata and gain control of its liquid biopsy products.
Trapelo Health Helps with Decision Support
COMING FAST IS THE NEED FOR ALL CLINICAL AND PATHOLOGY LABS to become masters of data and informatics. The need is twofold. One need is to streamline and automate the processes of lab ordering, reporting, billing, and collections. The other need is to deliver actionable intelligence that helps physicians make faster, more accurate diagnoses.
NeoGenomics knows this, which is why it added to its data management capabilities. Earlier this year, NeoGenomics paid $65 million to acquire Burlington, Mass.-based Trapelo Health, a precision oncology decision-support software provider.
Trapelo’s decision-support platform aids doctors, labs, and payers by enabling information about testing and treatment, a news release explained. Clynt Taylor, Trapelo CEO, told Clinical Omics that the platform:
- Identifies biomarkers for which cancer patients should be tested.
- Lists labs that can do the tests for those biomarkers.
- Identifies available reimbursement by payers.
Neogenomics recognizes that the more it can automate and interface with payers’ prior-authorization systems, the easier it becomes for physicians to order genetic tests and for Neogenomics to get payment for its test claims.