Heat Biologics, a publicly traded North Carolina biotechnology company, is adding a rapid point-of-care COVID-19 diagnostic test to its product development pipeline.
The new test is in addition to the provisional patent application the Morrisville company filed March 3 to apply its immune system activating technology to prevent and/or treat COVID-19.
The company has focused mainly on treating cancer, but recently shifted toward coronavirus.
NCBiotech recruited Heat Biologics to North Carolina from Miami in 2011 and awarded the business a $225,000 Strategic Growth Loan. Heat is one of several companies supported by funding from NCBiotech that are now racing to develop products to deal with the COVID-19 pandemic.
Heat reported today that it is collaborating with the University of Miami to develop a proprietary patient-friendly COVID-19 point-of-care diagnostic test. The new test will require a simple pharyngeal throat swab to deliver on-the-spot results on a paper strip in less than 30 minutes.
In contrast, current tests for COVID-19 usually rely on the use of expensive thermal-cyclers, with results in five to six hours or require blood samples to detect antibodies to show the body’s defense against a previous exposure.
Heat says its preliminary research suggests the new test is specific to the novel coronavirus, with no cross-reaction to previous coronavirus subtypes such as the common cold. The test is designed to enable cost-effective manufacturing amenable for mass production and deployment around the world.
The test was developed by Sylvia Daunert, PharmD, MS, PhD, chair of biochemistry and molecular biology at the University of Miami Miller School of Medicine, along with Sapna Deo, MS, Ph.D., and Jean-Marc Zingg, Ph.D., both also faculty at the Miller School.
“Our lab has tremendous experience developing accurate and easily usable tests for infectious diseases such as HPV and Zika,” said Daunert. “Unlike tests that detect antibodies (IgG and IgM method), which can take weeks to manifest, our test is being developed to utilize molecular recognition and amplification of the target virus. This should allow for much-earlier detection, within a couple days of exposure, providing critical and time-sensitive information to help curb the spread of the disease.”
Daunert added, “Additionally, our test is designed to provide a read-out in a fraction of the time required for most other tests, has no technical hardware requirements, and offers high sensitivity and a simple binary paper readout that can tell the healthcare provider if the patient is positive for a disease within 30 minutes. I am very excited to collaborate with Heat Biologics in order to bring our expertise to bear in fighting this pandemic.”
Heat CEO Jeff Wolf added, “We are honored to work with Dr. Daunert and the University of Miami to develop this exciting new platform for early and quick diagnosis of COVID-19. Her lab has developed multiple bioassays against similar diseases, and we are eager to utilize these tools in the war against COVID-19. Importantly, we believe this point-of-care diagnostic will address many of the challenges facing existing tests, including time to readout and cost. We look forward to providing further updates on this platform in the near future.”