NEW YORK (GenomeWeb) – Next-generation sequencing may be the go-to technology for oncologists, but a new study has demonstrated that using sequencing in combination with other molecular profiling methods might produce better outcomes for patients.
Investigators from OncoDNA, a Gosselies, Belgium-based cancer theranostics company, recently described the use of sequencing, immunohistochemistry, DNA methylation, microsatellite instability testing, and other methods to improve treatment decisions.
The firm hopes the effort, described in the journal Oncotarget, will spur adoption of its testing services by oncologists, particularly in Europe, where it is determined to become a market leader.
"Our priority is to be the European champions," said CEO Jean-Pol Detiffe. "Europe is complex, and each country has its own system for reimbursement," he said. By promoting its offering via journal publications, the company hopes to not only attract more interest, but ultimately win reimbursement across the region, he said.
Founded in 2012, OncoDNA has rolled out a menu of tests based on a variety of technologies, including sequencing and immunohistochemistry, to generate a patient profile that can be used to gauge response to chemotherapies, immunotherapies, and targeted treatments. The company employs 55 people and maintains a subsidiary in Spain called BioSequence that serves not only Spain and Portugal but also the Latin American markets.
For the new study, which ran from January 2015 to January 2016, OncoDNA and its clients looked at samples from 1,057 late-stage and advanced-grade cancer patients from over 30 different countries for whom at least one standard-of-care treatment had failed. Breast, colorectal, lung, and gynecological cancers comprised the majority of the cancer types surveyed. Others were sarcomas, pancreatic, gastric, brain, prostate, head and neck, and liver cancers, as well as melanoma, cancer of unknown primary, cholangiocarcinoma, and other rare cancers.
The goal was to assess the extent to which OncoDNA's treatment recommendations influenced therapeutic decisions.
The samples in the study were interrogated by sequencing DNA from solid biopsies using either OncoDNA DEEP, a custom panel of 207 amplicons covering hotspot mutations in roughly 65 genes, or the firm's OncoDEEP Clinical assay, which sequences 16,452 amplicons covering whole exons of 409 genes. Both are modified versions of Thermo Fisher Scientific's Ion Ampliseq Cancer Hotspot Panel and Ion Ampliseq Comprehensive Cancer Panel, respectively. OncoDNA also carried out immunohistochemistry as well as other biomarker tests on the samples. The study also analyzed the therapeutic decisions made by oncologists after receiving OncoDNA's reports.
Based on those data, OncoDNA and its partners determined that sequencing alone supplied useful information to oncologists in between 10 percent and 50 percent of cases, depending on cancer type. The addition of immunohistochemistry, however, "increased extensively the usefulness of the information provided," the authors wrote.
Most treatment decisions — roughly 93 percent — were based on the combination of data generated by sequencing and immunohistochemistry, as well as other molecular tests. In the majority of cases, an approved drug rather than clinical trial enrollment was the treatment selected.
The authors also observed that 27 percent of patients had an overall survival of greater than a year, even though these were patients who were not expected to live longer than three months.
"The nice thing about this study is that we were less known [when the samples were collected] than now," said Detiffe. "So the oncologists that were trying us were using our tests in only the most difficult cases, always in late-stage patients, after the failure of not only the first-line treatments, but even after the third-line therapies," he said. "We were the last chance," he added.
The results should help OncoDNA to promote its services in its home market: Europe.
"We know what we are doing, and we are very good from a technical point of view, but from the perspective of oncologists, if we want to attract more of them, a peer-reviewed paper based on real-world data is needed," Detiffe said.
In terms of competition, OncoDNA has managed to distinguish itself by relying on a variety of technologies. While many labs have brought sequencing in house, they lack the expertise to run immunohistochemistry, considered to be the domain of pathology labs, Detiffe noted.
"There aren't a lot of companies doing that because it's quite complex, and it's not just NGS, you need to have a lab with other assays," he said. "We run 50 complementary tests, so we have combined two worlds."
One competitor Detiffe acknowledged is Cambridge, Massachusetts-based Foundation Medicine, majority-owned by Roche, which sells its tests in 27 countries. Last year, Foundation Medicine also opened a digital oncology testing service lab at Roche's site in Penzberg, Germany. Foundation will also be OncoDNA's main competitor in the US, when OncoDNA decides to enter that market.
Detiffe said the US is the "next step" for OncoDNA, but he did not discuss a timeline for launching its services there. He noted that to do so, OncoDNA will have to either establish a CLIA-compliant laboratory or find a partner. However, he maintained the company's main priorities are growing its European business and winning reimbursement for its tests.
OncoDNA has been racking up distribution agreements in recent months, naming partners in Armenia, Bulgaria, Russia, and Latvia. In September, the firm announced that a number of private health insurers would reimburse its OncoStrat&Go test in the UK. OncoStrat&Go is a combined liquid biopsy and tissue test. It relies on a genetic profile of a patient's tumor to predict response to targeted, immunotherapeutic, and chemotherapy treatments, according to the firm.