IdentifySensors Targeting Cancer Testing With Ultrasensitive Sensor Technology

Original from: genomeweb

Diagnostics firm IdentifySensors Biologics has recently demonstrated proof of concept for the use of its electrochemical sensor-based diagnostic platform Check4 for cancer testing and is now moving closer to commercialization of the platform and related tests.

The firm's platform was developed at Case Western Reserve University and began as a tool to detect viral and bacterial DNA and RNA, but it's sensitive enough to detect circulating tumor DNA, giving it potential as a cancer diagnostic, said IdentifySensors CEO Greg Hummer.

The Cleveland-based company recently validated the platform for non-small cell lung cancer after an undisclosed large pharmaceutical company reached out to IdentifySensors to see if the platform could be used to detect three mutant NSCLC genes in model blood samples: L858R, exon 19 deletions, and T790M. It did so with sensitivity down to 50 copies per milliliter - comparable to US Food and Drug Administration-cleared PCR-based tests and "definitely in the diagnostic range," Hummer said.

The platform's core technology comprises an electronic semiconductor with screen-printed graphene electrodes engineered for optimal conductivity and biomolecule attachment, Hummer said. For cancer detection, the company immobilizes short single-stranded DNA probes that are each complementary to a specific mutation onto the surface of the graphene. When a matching gene is present, the probe hybridizes and lifts away from the graphene, changing the electrical charge and allowing the current to move through the semiconductor at a faster rate. If the current increases, the target gene is present and the test is positive, but if the current stays the same or decreases, the test is negative.

Results can be returned in less than five minutes through an app on a Bluetooth-enabled device, as the data from the reader is transmitted to the cloud and interpreted. The technology was previously. validated with saliva and works with multiple sample types.

The Check4 testing platform consists of a reusable reader and a disposable cartridge. The company has produced about 8,000 readers through a partnership with a contract manufacturer and plans to mass-produce the cartridges and standalone sensors soon through the same partnership.

Thus far, the company has raised $20 million to support the development and commercialization of its technology and is aiming to raise an additional $7 million in a Series A round to further develop its cartridge technology and finalize its go-to-market strategy, Hummer said. The firm then plans to raise another $26 million primarily for clinical testing to support commercialization, he added.

The company plans to focus commercialization on point-of-care settings, including doctors' offices, hospitals, and urgent care centers, although Hummer noted that it hopes to partner with a CLIA-certified laboratory to create a laboratory-developed test based on the circulating tumor DNA detection technology for lung cancer in the next eight months.

Hummer said the company envisions that this test will use the "same exact science" but will "strip away" most of the cartridge and allow for direct pipetting of a sample onto the sensor. He added that the company will likely seek US Food and Drug Administration approval for a cancer test but that offering the assay as an LDT "will get us to market early."

It also intends to expand its work into companion diagnostic tests for oncology.

In Hummer's view, the technology will allow Identify Sensors to bring a "very affordable" product to the cancer testing market to enable widespread screening. Although he did not specify the estimated price of the test, he said it will likely be reimbursed by insurers.

In the meantime, Identify Sensors is still pursuing infectious disease applications for its technology. In March, it submitted its platform and a blood-based Ebola virus test to the FDA, and is still awaiting a response. The firm plans to offer the hardware at cost and then charge customers based on test usage, charging mostly for the results interpretation rather than the hardware, Hummer said.

The company is also currently developing a variety of infectious disease assays, including a respiratory panel with influenza A/B, respiratory syncytial virus, and SARS-CoV-2 targets, as well as tests for hepatitis C and Streptococcus. It also plans to develop assays for common cancers, in addition to its lung cancer assay.

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