This story has been updated to clarify Luis Diaz's affiliation with liquid biopsy firm PGDx.
NEW YORK (GenomeWeb) – Liquid biopsy firm Cynvenio Biosystems announced earlier this month that it is now offering a blood-based monitoring service to track disease status or to surveil for early signs of recurrence in breast cancer patients.
This type of monitoring has been the focus of significant attention amongst liquid biopsy researchers. But to date, most clinical testing remains limited to less frequent analyses.
But with encouraging results from studies showing that the presence of circulating tumor cells, associated cell-free DNA, or extracellular vesicles, can preclude other signs of recurrence or metastasis — sometimes by long periods — commercial firms have begun to stake claims in this new indication.
While physicians can already use liquid biopsy assays from a variety of companies to monitor their patients serially if they wanted — simply by ordering multiple tests at different timepoints — Cynvenio has taken things a step further by defining this as a specific product, paid for on a yearly basis.
The new test program, called ClearID Total Insight, is a 12-month monitoring service that includes Cynvenio's sequencing-based liquid biopsy testing, along with a proteomic test that gauges the activity of natural killer (NK) cells.
Customers that don't already know their BRCA1/2 status also receive a one-time germline cancer risk mutation analysis via Color Genomics as part of the package through a partnership the two companies announced earlier this year.
The goal of the serial blood testing is to detect signs of recurrence in patients who have reached remission, or to look for signs of metastases in patients undergoing treatment. Four rounds of both Cynvenio's liquid biopsy test and the NK activity testing are included per year.
The company has not disclosed the price of the new program, but claims that one 12-month period costs less than a single comprehensive liquid biopsy test from other providers.
Cynvenio CEO André de Fusco said in an interview this week that the company's new service comes out of results that it has collected from a surveillance trial of triple-negative breast cancer patients.
The firm announced that study, combining its sequencing-based liquid biopsy with South Korea's ATGen Global's ELISA-based NK Vue testing, in December 2015.
De Fusco said the trial began in March of 2016, and the company has been following more than 200 patients with either monthly or quarterly testing. "We are looking in the two-year window after treatment when [these patients] have a high chance of recurrence, compared to [the] rest of [the] breast cancer population. And this new monitoring program comes out of what we found in that study," he explained.
Although interested doctors could order multiple tests on their own initiative prior to the launch of this service, de Fusco said Cynvenio believes that offering a program goes further to help interested patients.
The company is not working under a direct-to-consumer model, but he said that Cynvenio "talks to patients and their doctors in that order." Doctors have to order the testing service, but patients could express their interest to their physician or potentially seek out an oncologist willing to pursue this type of program.
Recurrence monitoring is something that is requested by the patient community, and considering the results it has seen in its research, Cynvenio believes that its technology can provide that, de Fusco said.
"If you can make the test available for a few hundred dollars and allow doctors to test patients repeatedly, we think that's how things are going to shake out," de Fusco said.
Cynvenio is not alone in this. Other early movers in this area include Taiwan-based CellMax Life, which offers liquid biopsy tests for both early detection of new colorectal cancers in asymptomatic but at-risk individuals, and monitoring for resistance or recurrence in treated patients.
In the US, Pathway Genomics also offers blood-based mutation testing both for early-detection and recurrence monitoring. The firm says that physicians can use its CancerIntercept Monitor test to monitor tumor evolution, assess residual disease, and check for recurrence.
But not everyone in the liquid biopsy field agrees that there is enough evidence yet to support clinical or commercial testing in this vein.
Luis Diaz, a researcher who recently joined Memorial Sloan Kettering Cancer Center and a co-founder of another liquid biopsy firm, Personal Genome Diagnostics, said that in his opinion, the clinical utility data isn't there yet to suggest that doctors should be tracking cell-free DNA, CTCs, or other targets in cancer patients' blood in standard clinical practice, let alone purchasing test packages commercially.
Yes, there is exciting data suggesting that you can detect recurrence using circulating DNA or other targets, but the necessary clinical utility studies have yet to be completed or published, he said.
Cynvenio has not presented or published yet on the validity or clinical utility of this mode of testing. Nor have some other companies that market similar programs.
Pathway, for example, came to the attention of the US Food and Drug Administration soon after launching the early detection version of its CancerIntercept test. The FDA sent the firm a letter raising concerns about a lack of published evidence "that this test or any similar test has been clinically validated as a screening tool for early detection of cancer in high-risk individuals."
De Fusco said that Cynvenio will share data from its triple-negative breast cancer monitoring trial at an upcoming scientific meeting, hopefully by the middle of this year. Though the trial is ongoing, "we have had recurrences, so the data is there that we need," he added.
Meanwhile, some of the most promising data to be published in this area has come from researchers like Diaz and his colleagues. For example, a study conducted with the Institute of Medical Research in Melbourne, Australia demonstrated last year that circulating tumor DNA can be used to identify colorectal cancer patients who are likely to have a recurrence after surgical tumor resection.
However, Diaz said, results like these are still preliminary, and though they are immensely encouraging for further clinical research, they're not enough yet to support clinical or commercial use.