NEW YORK (GenomeWeb) – Biocartis is expanding into the oncology space with a planned series of immunotherapy and liquid biopsy assays on its flagship Idylla molecular testing platform.
The Belgian firm last week laid out plans for liquid biopsy panels for guiding therapy selection for cancer patients and monitoring therapy response, post-therapy minimal residual disease (MRD), and recurrence.
During a conference call with investors to discuss its full-year 2018 earnings, Biocartis CEO Herman Verrelst said that the liquid biopsy assays will complement certain solid biopsy tests for therapy selection.
Verrelst also believes that the Idylla's rapid turnaround time will allow a high-volume menu for repeated testing over time for patients with recurrent disease.
Specifically, Biocartis said that it expects to submit to the US Food and Drug Administration for 510(k) clearance of its Idylla MSI colorectal cancer test in 2020, followed by a submission for premarket approval of its Idylla RAS test also in 2020. Regarding lung cancer, the firm aims to launch a research-use-only version of its Idylla ct-EGFR assay midway this year, followed by the commercial launch of its Idylla GeneFusion Panel next year.
For breast cancer, Biocartis plans to begin European validation studies for its Idylla Oncotype DXi IVD Breast Recurrence Score test in H2 2019, followed by the commercial launch of the test in Europe in 2020.
Biocartis has three major components to its immunotherapy strategy, which will target immune checkpoint inhibitors and cell therapy. For immune checkpoint inhibitors, the firm believes it could build on its CE-IVD microsatellite instability (MSI) assay, as the marker is used for immune checkpoint inhibitors and has the potential to be a pan-cancer biomarker. The firm aims to apply the assay for colorectal cancer immunotherapy, with a potential for pan-cancer validation in the future.
In addition, Biocartis is examining the potential of developing a "hot-cold" signature assay to provide information as to whether a patient's immune system is already fighting the cancer or if it needs to be activated to fight the tumor. The firm also plans to add immunotherapy resistance markers to the Idylla menu, which it believes will help doctors determine which treatments, especially immunotherapies, will work in the patient.
Biocartis also briefly discussed Idylla's potential role in the cell therapy field. The firm believes it can develop tools to help patients manage disease while receiving such therapy.
Biocartis Strategy Lead Simone Marticke noted that the firm can also play a role in liquid biopsy-based therapy selection for certain tests that "mirror content of therapy selection tests for solid tumors samples." In addition, the firm will target liquid samples from different tissues that are not available during diagnosis or during the disease progression.
"We aim to develop a menu for on-therapy response monitoring and detection of minimal residual disease after treatment," Marticke said. "These two areas in particular require a very fast turnaround time because clinicians depend on the results to make a treatment decision."
Marticke highlighted several examples where the firm could use Idylla assays in clinical settings. First, she noted that liquid biopsy would benefit patients who are receiving immunotherapy. While imaging may show that the tumor is growing shortly after drug treatment, it cannot accurately determine the drug's effectiveness in killing the tumor. Instead, Marticke argued that clinicians could use a liquid biopsy as a "real-time test of tumor load" to track the drug's effectiveness.
In addition, Marticke noted that researchers could use the firm's liquid biopsy assays to detect MRD after a patient's surgery. She believes that a series of sensitive liquid biopsies administered post-surgery may help researchers easily and rapidly determine the presence of MRD and lead to "to make an informed choice as soon as possible."
Biocartis also believes that recurrence monitoring is another useful application for the Idylla liquid biopsy menu as it involves following patients over the long term and potentially testing them several times a year.
"We see liquid biopsy testing as a high-volume opportunity, as some applications in particular require fast turnaround times, and these are the ones we will focus on with the Idylla," Marticke said. "With the menu we laid out, we will be able to test a wide range of cancer patients going from early to late stage and different cancer types and spanning different treatment classes, as well."
On the conference call, Verrelst also broke down the overall long-term potential of Idylla assay cartridges across different cancer spaces in the European, US, and Japanese markets based on management estimates.
For targeted therapies, the firm believes it could address an estimated volume of 3 million to 4 million Idylla cartridges, primarily targeting colorectal cancer, lung, and melanoma cancer markets, as well as a potential application for a menu in the pan-cancer setting. The firm based the volume on incidence and current as well as anticipated cancer guidelines for colorectal, lung, and skin cancer.
Regarding immunotherapies, Biocartis believes it could address an estimated 4 million to 5 million Idylla cartridges with the Idylla platform. The firm based the estimate on the incidence and current as well as potential guidance testing eligibility for cancer types, where immune checkpoint inhibitors are the most relevant.
However, Biocartis sees the highest market potential in the unfinished menu for monitoring — including recurrence monitoring, therapy monitoring, and minimal residual disease — over the long term, with an estimated 10 million to 15 million tests per year. The firm based the estimate on the incidence, potential eligibility, and number of tests per cancer patients.
"Taken together, the menu we are working to build supports a substantial cross section of the most important clinical decisions that the oncologists will need to make, especially those decisions that need to be made at utmost speed," Marticke said.
Later in the year, Biocartis also expects to work with external partners who have their own validated and high-value oncology gene signatures.