Gaithersburg, Md.-based startup Hememics Biotechnologies Inc. is partnering with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a rapid, Bluetooth-connected, point-of-care (POC) test for COVID-19. Designed for use in both field and traditional settings, the test detects SARS-CoV-2 and related antibodies from nasal swabs and whole blood, delivering results in a minute or less.

Under the $638,000 contract, Hememics will work with BARDA, part of HHS’ Office of the Assistant Secretary for Preparedness and Response, to finish developing its rapid POC biosensor system and clinically validate it as a diagnostic tool for identifying viral particle and IgG and IgM antibodies to COVID-19. The project will also focus on establishing quality manufacturing processes and scaling up production.

“We expect to have it out by the end of the summer” via an FDA emergency use authorization, John Warden, Hememics’ CEO and co-founder told BioWorld.

Portable, easy-to-use platform

The portable platform uses a multiplex, electronic chip that can simultaneously detect up to 17 different viral and bacterial pathogens from a swab or a finger stick to quickly identify exposed individuals and limit the spread of infection. A proprietary solution, Hemsol, preserves antibodies collected on carbon nanotubes on the chip, extending shelf life and eliminating the need for refrigeration.

Hembox biosensor system. Credit: Hememics Biotechnologies Inc.

About the size of a cellphone, the device has a long battery life and easy-to-read color screen. Test results can be linked to cloud-based data management networks using Bluetooth for on-the-spot screenings at airports or ports or for real-time geolocation of disease outbreaks, the company said.

Among the issues clinical testing will assess is the potential for cross-binding, Warden said. “People have a lot of antibodies to coronavirus, but you have to be able to differentiate between that and COVID-19 antibodies.” He added the device can gauge the health of antibodies, based on their binding strength.

“The development of a diagnostic device and test that can screen patients almost instantly in the field or in a health care setting will help people determine whether they can return to work safely, provide timely information to inform decisions about treatment and provide data health officials needs in their continuous efforts to mitigate the spread of infection during this pandemic and potentially in future coronavirus outbreaks,” said BARDA Director Rick Bright.

Summer financing planned

Founded in 2007 as a protein preservatives company, Hememics turned its focus exclusively to diagnostics four years ago. The company was one of six technology startups that Fairfax, Va.-based Inova Health System invested in through its Inova Personalized Health Accelerator.

In December 2019, Hememics scooped up $2.5 million in a seed round from AMVI Partners, an investment firm comprised of high net worth Vietnamese investors. The company had earmarked the funds for development of its lab-on-a-chip technology for sexually transmitted infections, but has sidelined that effort while it focuses on a COVD-19 test.

“We have been working for years to develop a platform that could be adapted in days and scaled in a few weeks to counter emerging epidemics such as COVID-19,” said David Ho, Hememics’ co-founder and chief scientific officer. “The BARDA support will help us demonstrate the rapid utility of our device, as well as the broader networking capability to inform health care agencies and providers about outbreaks.”

Hememics is planning a new round of financing this summer, with the goal of raising a minimum of $3.5 million to support production and scale-up efforts. The company currently uses robotics to put the active ingredient on chips that are about five times the width of human hair. “It a capital intensive process to grow that capacity,” Warden said.

Still, he believes Hememics will reach that goal. “We’ve been at this a long time, not necessarily in virus protection but in other biologies,” Warden said. “We’re in the home stretch of finishing our platform, and we think we can have a meaningful impact on providing rapid point-of-care detection in resource-compromised situations.”

No Comments