NEW YORK – AnPac Bio-Medical Science, a cancer screening and detection company, is developing a diagnostic device that aims to differentiate between 11 cancer types based on the biophysical properties of blood components rather than specific biomarkers.
The device, designated AP9100 and based on the company's cancer differentiation analysis, or CDA, technology, relies on an array of sensors and key proprietary hardware such as a novel filter and microelectronics to locate cancers and estimate future cancer risk by measuring the biophysical properties of analytes found in patient blood samples, such as proteins, protein fragments, and cells.
By not relying on biomarkers for analysis, the new technology can test for several cancers for which no generally accepted biomarker exists, such as those of the esophagus, thyroid, and brain.
This potentially enables earlier and more precise cancer detection for those patients.
"In a biophysical-based detection," said Chris Yu, AnPac's co-founder, CEO, and chairman, "the reliance on reagents or traditional biomarkers [is] reduced. Yet, we discovered that we can detect more cancer types via our novel hardware."
Last week, the firm, which has headquarters in Shanghai and Ambler, Pennsylvania, filed its Class III diagnostic device for registrational testing with China's National Medical Products Association. Approval clears the device to be comprehensively compared to an equivalent product in China, a requirement for Class II and III devices, prior to clinical testing.
AnPac has shipped the AP9100 to designated testing labs, where they are currently awaiting testing. The company plans to initiate clinical trials once the device has passed this stage.
While the NMPA filing lists 11 cancer types, including lung, esophageal, gastric, rectal, colon, liver, breast, cervical, thyroid, pancreatic, and brain cancers, Yu pointed out that the company expects to be able to detect even more. Its website, for instance, states that CDA technology currently identifies patient risk for 26 different types of cancer.
Cancer detection by biophysical properties, particularly in liquid biopsies, exists in a relatively small field compared to other detection methods. AnPac is not alone, however, in following this path.
Angle's Parsortix technology, for example, enriches circulating tumor cells based on their different size and deformability, as compared to other cells. As patient blood passes through the Parsortix microfluidic cassette, CTCs' greater size and lower compressibility prevent them from exiting with non-cancer-associated blood components.
While the exact properties that AnPac assesses via its own device remain confidential, Yu stated that they comprise "a class of biophysical properties which control cell proliferation."
Other companies pursuing early detection of multiple cancers in a single test include Grail, which launched its Galleri test in June, and Thrive Earlier Detection (acquired by Exact Sciences), which is developing the CancerSEEK test.
As with the AP9100, both of these tests also use liquid biopsies. Galleri is designed to identify as many as 50 different cancers via methylation patterns on cell-free DNA, while the number of cancers potentially detectable by CancerSEEK, which evaluates the presence of genetic mutations, remains unknown while the test is under development.
Meanwhile, Burning Rock Biotech, also from China, is pursuing multi-cancer detection assays based on combining a variety of markers.
Burning Rock's current contribution consists of a 22-cancer screening assay that incorporates epigenetic and protein biomarkers, and potentially several others. This combination biomarker strategy is currently being tested in the PRESCIENT study, which began recruitment in May.
AnPac, which went public early last year, based its recent NMPA filing on the results of several past studies. In a previous statement, the company said that these studies amount to over 43,000 clinical samples covering over 60 cancer types.
The company presented four of these studies as abstracts at the 2015 American Society of Clinical Oncology Meeting. These assessed the use of CDA technology in esophageal, digestive system, and non-small cell lung cancers, and in hepatocellular carcinoma.
Patient blood samples were analyzed via CDA in these studies and compared to those of healthy controls and in some cases, to those of other illnesses. Combined, the studies comprised nearly 1,500 participants and showed sensitivities ranging from 70 to 87.7 percent and specificities from 70.9 to 90 percent.
In February, the NMPA had approved registrational testing for the AP9100 as an auxiliary diagnostic tool for lung cancer. AnPac had filed that application in 2018, expecting that a more limited application would be approved faster, making way for the more expansive multi-cancer filing.
"Now it appears that we will possibly get both of [the approvals] not that further apart in terms of timing," Yu said, "which is really great for us."
AnPac also plans to commercialize the technology as a multi-cancer lab-developed test in the US. In pursuit of that goal, its CLIA-certified laboratory, based in Philadelphia, gained accreditation from the College of American Pathologists on Monday.
At the time of writing, the company had not yet decided whether it would seek a CE mark for European commercialization.