This article has been updated to reflect further commentary made by the company.
NEW YORK (GenomeWeb) – Last month, iCareDx announced that it was rebranding itself as Acuamark Diagnostics as it works to raise funds for its first round of clinical testing.
"It is a more precise reflection of what we are doing," Acuamark President and CEO Bernard Peperstraete told GenomeWeb. "Acua is also a play on accurate and liquid, and Acuamark — or watermark — reflects that each cancer leaves a barely visible imprint, and needs to be looked at in a different light."
The freshly dubbed Acuamark is a biotechnology company that develops blood-based tests for the early detection of cancer. The company is currently working on diagnostic technology for its proprietary multiplexing platform which aims to detect a wide variety of molecules present in low abundance in cancer patients. Acuamark has convincingly demonstrated that the assays detect a variety of low abundance cancer biomarkers, such as mutations and expression signatures, and is currently raising funds to move towards clinical testing to obtain sensitivity and specificity data, Peperstraete said.
"Tumors vary greatly," Peperstraete added. "They can release a great variety of markers and marker types into the bloodstream, all of which need to be captured." The company is hoping its test will detect this wide variety of markers, including DNA mutations and messenger RNAs. Further, Peperstraete said, a really accurate and reliable test needs to be scalable to handle a wider spectrum of diagnostic markers. Most tests currently on the market look at a limited number of biomarkers, which he believes is a rather limited approach.
Acuamark is developing a suite of multiplexed detection assays that can detect a broad range of molecules at the single molecule level. These assays are run on commercially available instruments, and can be combined with next-generation targeted, deep sequencing, Peperstraete said.
"The assay is really a two-step assay," he explained. The first assay is a rapid, low-cost test that will allow the physician to determine whether a patient needs further screening or can wait until his or her next annual check-up. Blood samples that come back positive for early signs of cancer will be screened again with a second series of tests. Those results will further inform the doctor as to the need for follow-up or more advanced testing and imaging.
"The assays are expected to also be sensitive enough to help indicate the type of tumor, and whether relatively slow growing or aggressive," Peperstraete told GenomeWeb in a follow-up email. "One can think of it as the ultimate triaging tool in detection, and subsequent diagnostic follow-up in cancer."
Despite the early successes, however, it will be a few years before Acuamark's test is available on the open market, Peperstraete noted. There is still plenty of testing to do to make sure the diagnostic is accurate and efficient. The first of these tests is a pilot study of Acuamark's diagnostic in blood-based early detection of colorectal cancer. The company decided to pilot with colorectal cancer not just because of a large need, but also because of its many years of experience with colorectal cancer tumor types as well as the established regulatory and reimbursement path, Peperstraete said.
Once Acuamark has ensured the sensitivity and specificity of the product in colorectal cancer, it is developing a pan-cancer test, which the company believes will be "very feasible based on [its] current data," according to Peperstraete.
"Acuamark also believes its technology's focus on early detection sets it apart from several other post in vivo diagnosis verticals (such as companion diagnostics, treatment efficacy monitoring, recurrence monitoring) which are crowded," Peperstraete said. "But since it is not easy to see early and low abundance [molecules], the early [diagnostics market] is less crowded."
There are other companies that have expressed interest in the early cancer detection space, including Roche, Grail (Illumina), and Guardant Health. However, Acuamark designed its technology to fulfill criteria that are critical for a screening test to succeed: high accuracy, affordability, scalability, and accessibility for patients, Peperstraete noted.