LONDON – Neogenomics Laboratories Inc. is to make a $25 million equity investment in Inivata Ltd. and has taken an option to acquire all of the company as part of a U.S. commercialization agreement with the U.K. liquid biopsy specialist. Under the deal, Neogenomics will take over sales, marketing and billing for Inivata’s Invisionfirst circulating tumor DNA lung cancer test, which is intended to replace tissue biopsies.
The diagnostic captures and sequences tumor DNA from blood samples and can test for 37 tumor related-genes. That includes EGFR, ALK, ROS-1, NTRK, MET, RET and BRAF V600E, for which there are FDA-approved targeted therapies. In clinical studies, the test picked up 26% more actionable mutations than standard-of-care tissue profiling.
Invisionfirst has Medicare and some private payer coverage for patients with advanced non-small-cell lung cancer who meet certain criteria.
The preparatory groundwork is complete, and the product is ready for intensive marketing, said Clive Morris, CEO of Cambridge, U.K.-based Inivata. “What we have done so far is a sort of proof of concept for commercialization. We have coverage from Medicare and private insurers, and, after testing the value proposition, we’re at the point we want to scale. Neogenomics has the reach to do that,” Morris told BioWorld.
While Neogenomics, of Fort Myers, Fla., currently is a market leader in tissue-based lung cancer testing, Morris noted some lung cancer patients are not fit enough to have a biopsy. “So, there is complementarity,” he said. In addition, liquid biopsy is poised to become a “backbone” technology in tumor profiling. “There is a shift from tissue to blood,” said Morris.
Genomic profiling of all blood samples will continue to be carried out at Inivata’s lab at Research Triangle Park, N.C., from where test results are turned around within seven days. That compares to the two to four weeks it typically takes for a tissue sample to be analyzed.
The duo did not give any details on the timing of Neogenomics’ option to acquire Inivata, or in what circumstances it will be triggered. However, alongside marketing the Invisionfirst test, the two will work together to form collaborations with pharma companies to use the test in clinical trials.
They also will copromote Inivata’s new Radar assay for detecting residual disease and recurrence in patients treated for a range of cancers. The test, currently for research only, tracks up to 48 genetic variants, making it possible to see if a tumor has been removed completely by surgery. It also allows for quick detection of relapses.
“This is patient-specific. We create an individual bespoke assay from excised tissue to profile the tumor,” Morris said. It is envisaged that patients will have blood tests one month after surgery to check for the presence of any of the tumor-specific variants in the profile, and subsequently, to check for recurrence.
Even if tumors mutate or metastasize, they retain existing genetic variants. “They might gather new markers, but the original [ones] are retained,” said Morris.
For pharma companies, patients can be profiled and selected for clinical trials of targeted agents. It will be possible to track treatment effects, giving an early idea of whether a drug is effective.
The Radar test is about to be put through its paces, with the first trial in lung cancer due to take place at Cambridge University. Other studies – in breast and head and neck cancer – will be announced at the American Association for Cancer Research virtual meeting, taking place between June 22 and 24.
Morris said the COVID-19 pandemic has slowed progress in setting up these trials. The “big, big disruption” in cancer care also has had an impact on the number of Invisionfirst lung cancer tests. “That’s been the case even though in reality patients with advanced lung cancer still need treatment,” he said.
Inivata’s profiling lab has remained open throughout the pandemic. To circumvent the problem of patients not going to outpatient clinics, it has set up a mobile phlebotomy service to take blood samples in individual’s homes. “We were thinking about doing this anyway. COVID-19 made us bring it forward,” said Morris.