NEW YORK (360Dx) – French oncology diagnostics firm HalioDx has opened a lab in Richmond, Virginia in order to expand its North American business operations by running its flagship assay, a test for colon cancer patients that measures immune response in a tumor to determine risk of recurrence and guide adjuvant treatment.
Marseille, France-based HalioDx will offer it's CE-IVD marked immunoassay-based colon cancer test, called Immunoscore Colon, in the US as a lab-developed test. The assay was validated last year in a large prospective trial published in The Lancet, and HalioDx projects that it will be competitive with commercial assays for colon cancer treatment guidance that use genomics-based methods.
The firm was founded with the Immunoscore core technology in 2015 following an $8.2 million buyout by the senior management team of Qiagen Marseille, a division that had previously been formed by Qiagen's acquisition of Ipsogen. A US expansion was a logical next stage for the firm, Vincent Fert, CEO of HalioDx, said in an interview, in part because "the US is a territory where there is high recognition of the value that diagnostics can bring to the patient and to the oncologist."
The company scoped out several US locations, Fert said, particularly on the East coast, since the time difference between the West coast and the Marseille headquarters would be a challenge. In Virginia, Fert said, there was the added benefit that its US base would not be "that far from Washington" and the US Food and Drug Administration, Fert said.
HalioDx closed a $22.7 million Series B round in late 2017, and it has now invested approximately $1 million into the new CLIA-certified facilities in Richmond, "so it is still rather modest," Fert said.
The 7,000-square-foot site opened earlier this month. It has 11 employees, of which five are new sales hires. The US sales force will specifically target gastrointestinal oncologists in regional hospitals "where they don't have access to a sophisticated pathology lab," Fert said.
In the colon cancer recurrence risk testing space, Immunoscore is likely to see competition from assays for genetic signatures of tumors samples. These include a 12-gene test called Oncotype DX Colon Cancer from Genomic Health, and Agendia's 18-gene ColoPrint assay.
However, "These tests are not yet included in the guidelines, and they are very scarcely reimbursed," Fert noted.
These assays are molecular, while the HalioDx test is an immuno-oncology diagnostic. Specifically, Immunoscore uses automated immunohistochemistry and digital pathology of formalin-fixed, paraffin-embedded tumor biopsies, measuring the density of CD3+ and cytotoxic CD8+ T cells in the tumor and invasive margin.
"We are quantifying the immune response by looking at lymphocytes in and around the tumor — it is a very different principle — and also we have demonstrated far superior performance [compared to the molecular technologies]," Fert said.
A recent review of molecular methodologies focusing on colorectal cancers suggested biomarkers remain limited in current clinical practice, but also noted that there is "evidence of promising clinical utility" for methods like Immunoscore that use infiltration by immune cells.
Furthermore, the molecular methods that use gene expression profiles to guide adjuvant treatment in colon cancer have not achieved the same level of clinical utility as those for breast cancer, for example, according to a 2017 Journal of Oncology Practice review. "Although several commercial assays are available, none have been incorporated into guideline recommendations because of the lack of large, prospective trials with independent validation," the authors wrote.
Trials for molecular test include one for Agendia's ColoPrint, referred to as the PARSC trial, which has been ongoing since 2008. It intends to gauge the test's ability to determine risk of recurrence in stage II colon cancer over a period of years with a target to achieve enough statistical power of enrolling around 600 patients. There have also been two outcomes studies of the ColoPrint test described in three articles — published in Clinical Colorectal Cancer, Oncologist, and Value Health.
Meanwhile, one retrospective clinical trial from the University of Arkansas is registered for Oncotype DX Colon Cancer, specifically evaluating racial differences.
Overall, these showed patients were more likely to receive decreased, rather than increased, treatments after use of the Oncotype DX test, but the majority did not have a change, as summarized in a recent technology evaluation. The test did seem to help improve the agreement between physicians and patients regarding treatment plans, yet an economic analysis of the test showed a lifetime cost decrease of only approximately 1 percent.
By contrast, the study of Immunoscore in The Lancet last year validated the test on more than 3,000 patient samples and showed that patients with a high Immunoscore had the lowest risk of recurrence at five years compared to those with a low score, although the study did not assess health economics considerations. Nevertheless, "This is a landmark in our clinical development," Fert said.
HalioDx has now run validation assays at the Richmond site, Fert said, adding its test can now be offered through the CLIA-certified facility. It is about to receive its first samples from hospitals in the US, he said.
The firm also has a reimbursement roadmap for the US involving the Centers for Medicare and Medicaid Services and private payors over the next three years that includes demonstrating adoption of the test. As it is currently offered as a lab-developed test, patients likely must cover the cost themselves for the time being.
Internationally, in the UK HalioDx has partnered with distributor Everything Genetic, which has negotiated a reimbursement milestone for coverage from an undisclosed "large insurance company." HalioDx noted this was achieved five months after commercialization. The firm expects this may also open up discussions with other payers there.
It has also begun a partnership with a startup digital pathology company, called Keen Eye Technology, which has developed an image analysis technique that leverages artificial intelligence, Fert said. The collaboration "is very important for us because Immunoscore uses a lot of image analysis deploying sophisticated technology and we wanted to be sure to have the right partner to handle this technology, and to improve it."
The customers in South America can now send out samples to the lab in Richmond, while samples from other locations are sent to Marseille. In China, the firm is pursuing a partnership with a company with a lab, because it is not allowed to ship samples out of China for diagnostic testing, Fert said.
HalioDx plans to develop the Immunoscore technology for other cancers as well, as previously reported, and further expects to see interest from US-based pharmaceutical firms running colon cancer clinical trials.