This article has been updated to reflect additional information about Ancon Medical's plans to pursue a regulatory pathway and its commercial launch.
NEW YORK (360Dx) – Ancon Medical moved one step closer to launching its disease biomarker identification technology after announcing that its nanoparticle tagging technology (NBT) demonstrated higher sensitivity in detecting signs of disease than a conventional method.
The medical device firm made the announcement last month after comparing its technology in verification tests against the current state-of-the-art method, ion mobility spectrometry.
Developed by Boris Gorbunov, currently Ancon's technical director, the NBT platform uses nanotechnology molecular tagging with a front-end selector gas chromatograph attached to a breath sampler to detect volatile organic compounds (VOCs) as breath biomarkers.
"After a breath sample is collected, it is introduced in a [gas chromatograph] inlet where biomarkers molecules are separated from other molecules in the sample," Ancon CEO Wesley Baker said in an email. "Only molecules of the biomarkers are ionized and tagged with tagging objects. Tagged biomarkers are then detected in the NBT detector by optical counter."
The current NBT platform, which is about the size of a computer monitor tower, is designed to be portable, and Ancon plans to make an even smaller version of the platform down the line. To collect breath samples in patients, Ancon uses disposable breath collectors, which eventually could enable greater versatility for collecting samples, according to Baker.
There are currently 400 known VOC biomarkers in the field that have been confirmed by research published in technical and scientific journals. Thus far, the company has focused most of its efforts determining NBT's use as a noninvasive screen for early lung cancer detection. However they have also explored the idea that it could be used as a possible method to detect an infectious disease, such as Zika virus.
"We expect to find [some new biomarkers] in our future trials due to [the technology's] sensitivity," Baker said, adding "Our aim is to build a library of VOC biomarkers and help contribute to further long-term research for all diseases."
Ancon's NBT technology fits within the larger noninvasive diagnostic space alongside liquid biopsy technology. Proponents of breathalyzer technology claim that breath sampling is less invasive than most blood-based liquid biopsy technologies on the market, since taking a blood sample is more physically taxing on the patient than breathing into a device.
One of the verification tests announced last month was conducted at sister company Ancon Technologies' laboratory in the United Kingdom, and the other was done at an independent European research facility in Hungary. The tests compared the company's NBT technology with gas chromatography–mass spectrometry, which is widely used to identify substances in a test sample.
According to Baker, earlier tests comparing the NBT detector with other technologies found that Ancon's technology was able to detect VOCs in the picogram range. "A conventional state-of-the-art technology, based on ion mobility spectrometry, only goes down to [the] 1 nanogram," detection level, he said, adding that NBT detector sensitivity is 200 times greater than ion mobility spectrometry.
Additionally, Baker noted that in a test to detect acetone, one of the VOC biomarkers related to diabetes, NBT could detect the biomarkers at 60 ionized molecules per cm3, which corresponds to 2.4 x 10-3 parts-per-quadrillion. He said that conventional methods only detect the biomarker above the one ppq level.
While the verification tests are an important step forward in the potential commercialization of the technology, the method is still in the late developmental stage. According to Baker, the NBT detector is at a point where a prototype has demonstrated operational scale. Soon, he added, the company hopes to move it beyond a prototype and to have a fully integrated and operational hardware and software system.
"We are now looking to work in close collaboration with several research and university facilities, as well as in the veterinary environment, before we launch our first product within the healthcare environment," he added, although he declined to provide a more specific timeline.
The price for the detector is expected to be $29,500 at launch, Ancon said, with a target market that initially includes research facilities, hospitals, healthcare clinics, and veterinary centers. Baker noted that the company envisions the technology being used at local pharmacies, and even at home down the road if they are successful in making a compact version of the platform. He also said that the company planned to pursue US Food and Drug Administration approval for its platform.
Ancon — which has an office in Minneapolis, Minnesota, and another in Kent, UK — will have competition in the so-called "breathalyzer" diagnostics space. One other firm, Owlstone Medical has launched its FAIMS technology, an ion mobility spectrometry-based platform that uses the Faraday cup, that also analyzes VOCs for disease diagnoses.
"In direct comparison of our detector with a conventional detector based on the Faraday cup, we detected ionized biomarkers in the air at the attoampere level," he said. Attoampere is an SI unit of measure that is equivalent to 10-18 amperes of electric current. He noted that ion mobility spectrometry-based technology detects ionized biomarkers at the femtoampere level (10-15 amperes), meaning the NBT can detect biomarkers at 1,000 times lower levels than the Faraday cup.
The company is now working through the final rounds of testing the NBT platform before launching it, though Baker declined to provide more details about the timeframe for the system's launch. He noted that Ancon planned to begin it's initial product launch in the US.
He also declined to provide information about Ancon's funding, saying only that "To date, Ancon Medical has been funded via non-dilutive funding only. We have a strategy in place for strategic partners, continuing non-dilutive, and private funding."