Widespread testing is going to be key to safely reopening businesses and global economies in the current pandemic. To that end, Kahala Biosciences LLC, an Irvine, Calif.-based testing and tracking startup, and its technology partner, Rymedi Inc., of Greenville, S.C., have launched the Adiona COVID-19 antibody testing platform, combining antibody testing with a blockchain-enabled smartphone app to increase predictability and traceability of potential outbreaks.

The Adiona platform combines a rapid point-of-care (POC) IgG/IgM fingerstick antibody test with an end-to-end blockchain solution designed to securely authenticate each test kit from the manufacturer to the patient, with immediate access to results from the cloud and the ability to conduct symptom tracking.

‘Virtual clearinghouse’

Adiona smartphone-based software. Credit: Kahala Biosciences LLC

“Authentication and reliability of antibody testing has been an issue as it has been introduced to this country,” said Francis Duhay, Kahala’s CEO. “We are focused on ensuring the quality and scalability of our antibody test and, to that end, have created a proprietary, first-of-its kind, secure platform that will ensure the authenticity of our products making their way to health care professionals and the patients for which they care.

“Beyond that, and perhaps more important to restarting our country, our platform technology will serve as a virtual clearinghouse to centralize protected, tamper-proof patient test results, which facilitates decisionmaking between employer and employee, so no other identification or testing is required to certify employee COVID-19 status.”

Because the platform can compile all test results and will eventually incorporate symptom tracking, it should “provide an accurate assessment of COVID-19 risk,” Duhay told BioWorld. He added that the platform is capable of doing symptom tracking now, but “there are finishing touches being made to tie everything together. The ultimate vision is for people to employ both viral antigen and antibody testing at home.”

All of the data is compiled through encrypted blockchain technology to satisfy any privacy concerns and prevent tampering and data loss.

Early use cases

Blockchain, which involves creating large-scale open networks and then incentivizing individuals to join those networks, originated as a secure means of transferring cryptocurrencies. The blockchain itself is a shared, digital diary that is unchangeable once a transaction has been recorded and verified. Potential use cases range from increasing supply chain efficiencies to improving data sharing and management to getting people to adopt healthy behaviors.

Adiona’s blockchain-driven data management uses predictive analytics to anticipate and respond to disease outbreaks while complying with HIPAA and good quality practice regulations.

Other examples of blockchain in health care have cropped up in recent years. In 2018, Walmart obtained a U.S. patent for a system that stores a person’s medical information in a blockchain database embedded in a wearable device and allows first responders to retrieve that information in a medical emergency. And the American Medical Association has provided some of the funding for Akiri Switch, a vendor-agnostic solution from San Francisco startup Akiri Inc. that uses blockchain to enable organizations to securely share and verify data across diverse systems.

In a 2017 Black Book Market Research survey, 19% of hospital executives and 76% of payers said they were either considering deploying or in the process of implementing blockchain tools to boost systems security and interoperability.

Built-in convenience

The Adiona platform for POC testing is designed to be easily used outside of a formal health care facility, such as in a company’s parking lot or outside the entryway of a building, Duhay said. “We have tested this in Greenville, S.C., and were able to test over 70 people in two hours with a walk-through testing model.”

Kahala is targeting employers with its web browser-based platform, which requires a doctor’s prescription before antibody testing can occur. The incentive to the blockchain-based platform is its ability to bring employees safely back to the workplace.

To initiate testing, patients enter their health information and receive a personalized QR (quick response) code, which is used to track them throughout the testing process. After they take the fingerstick test, their results are relayed to their phone within 15 minutes. Details regarding the test manufacturer, shipping, user health and personal information, payment, time and location of testing and results are all securely captured by the blockchain technology.

Fresh out of the gate

A newcomer to the med-tech landscape, Kahala debuted in April as a portfolio company of hyperaccelerator Koa Accel, going from conception to operating company in just four weeks to meet growing U.S. demand for COVID-19 testing. The company initially partnered with Salt Lake City-based Co-Diagnostics Inc. to distribute the latter’s Logix Smart COVID-19 test, which received emergency use authorization (EUA) from the U.S. FDA in April.

Kahala’s Adiona platform acts as a distributor for IgG/IgM antibody tests made by W.H.P.M. Inc., of Irwindale, Calif., Toronto-based Btnx Inc. and China-based Guangzhou Wondfo Biotech Co. Ltd. All three tests have been independently verified and are currently being undergoing EUA review, Duhay said. The Adiona platform itself does not require an EUA.

Future capabilities include symptom tracking via a daily digital questionnaire and expansion of POC testing. “Our vision is eventual at-home use,” Duhay said.