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POC Dx Firm Senzo Using BARDA Grant to Commercialize Infectious Disease Lateral Flow Tests


NEW YORK – On the back of a $750,000 grant from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority, point-of-care diagnostic company Senzo is working to bring its amplified lateral flow (ALF) technology to the market for COVID-19 testing and beyond. 

While the company has an immunoassay analyzer platform in development that will be able to run quantitative and multiplexed tests, the key focus for Senzo in the near-term — and the technology the BARDA grant is intended for — is its ALF tests, said CEO Jeremy Stackawitz. 

Founded in 2019 and based in Philadelphia, Senzo decided to try to make improvements in traditional lateral flow assays based on lessons learned from the COVID-19 pandemic. Some of the lateral flow products that have come on the market during the pandemic "aren't very good," Stackawitz said, and although the lowered barrier to entry was beneficial in getting tests to people who needed them, Senzo saw an opportunity to enter the market with a more accurate test. 

Stackawitz said that the company believes it can replicate central lab performance characteristics in a shorter time frame with cheaper materials — something larger diagnostic companies have been aiming to do since before the pandemic. "Everyone agrees that [rapid at-home and point-of-care tests] would be great, but they have to be as scientifically rigorous and as reliable as" central lab tests, he said. "That's really been the rub for the last couple of years, that someone needs to come along with a technology that can actually deliver the performance in these at-home and professional-use lateral flow tests." 

One of the only non-COVID-19 at-home tests currently available over the counter for an infectious disease is OraSure Technologies' OraQuick HIV Self-Test, although major diagnostic players have said they have other tests in the works. 

Senzo's ALF COVID-19 test largely follows the same process as other lateral flow tests: It requires a shallow nasal swab sample that is added to a buffer solution and then applied to a test strip. However, the test also uses a secondary amplification fluid that aims to boost the signal from virus particles even at low concentrations or volumes, Stackawitz said.

Other companies have tried to add an amplification step to lateral flow tests, he noted, but the issue is that, in addition to amplifying the signal of what a test is trying to detect, the amplification method also increases the background noise in a sample. That can result in false-positive results, he said. 

Senzo's innovation is in how it treats and designs the test strip to enable the targeted amplification of a virus without everything else getting in the way, he said. Normally, a detection antibody is immobilized on the test strip and reacts to the sample to determine the presence of the virus, but Senzo's test strips don't bind the antibody to a specific spot on the strip. 

Instead, when the virus is present in a sample, the detection antibody binds to the antigen and forms a "matrix picket fence" that captures the reagent to produce a positive signal that can be amplified, he said. In a negative sample, there's no antigen to bind to the detection antibody and everything flows to the end of the strip, returning a result in less than 10 minutes, he said. There's a "novel physical barrier" that enables the amplification, Stackawitz said. 

In a research and development study with Sheffield University using 50 samples, the test demonstrated 100 percent accuracy compared to PCR results. 

The design of the commercial version of the COVID-19 test is being finalized in the next month and will include the swab, buffer solution, and strip, he added. The firm also has a manufacturing partnership in place with San Diego-based NanoComposix.

The company aims to start clinical trials for the test by the end of this year to gather more data and prepare for regulatory submissions, including an application for Emergency Use Authorization from the US Food and Drug Administration. Senzo is "presupposing" it will need to also go through the 510(k) clearance pathway for the COVID-19 test and is preparing for that submission as well, Stackawitz said. 

The firm has filed patents for its intellectual property related to the ALF technology and is expecting those patents to be issued over the next year, he said. In May, the firm closed a $2 million equity funding round and so far, the company has raised $7.3 million in total, not including its $750,000 BARDA contract that will be used to help the test obtain EUA and reach the market. 

Although it is intended for home use, the company also plans to commercially pursue the professional-use market so that its test can be used in hospitals or other point-of-care settings, he said. Stackawitz said the test will cost less than $20 due to the low cost of goods from a manufacturing standpoint. 

Senzo expects to bring the COVID-19 test to market in the US itself and negotiate contracts with retailers to sell the test, but outside of the US, the firm will likely team up with other distributors. For tests beyond COVID-19, Senzo is talking with pharmaceutical companies and larger diagnostic firms that may be willing to license the test or otherwise bring it to market, Stackawitz said. 

While the company is based in the US, the research and development team is located in London, and the firm aims to bring its products to the European and UK markets, Stackawitz said. It is pursuing CE marking for its COVID-19 test, but non-COVID-19 test distribution would depend on relationships with third parties, and early distribution and commercialization efforts would likely be done with a partner, he said.

Senzo decided to bring the COVID-19 test to market first because it believes "there's going to be a robust COVID-19 testing market for years to come" that will allow the relatively unknown company to get its foot in the door and overcome any skepticism about the technology, Stackawitz said. However, he also noted that there is "COVID fatigue" and emphasized that the firm's strategy is to build on the momentum of the test and add more offerings, such as assays for hepatitis C, chlamydia and gonorrhea, and respiratory viruses, to name a few. The firm's potential offerings are "only limited by our imagination and bandwidth and funding," he said. 

Senzo is currently working on feasibility studies for a tuberculosis test using a urine sample, and it has plans for a triplex respiratory virus test that would distinguish between COVID-19, influenza, and respiratory syncytial virus, he said. That test would use three detection antibodies instead of one but would have basically the same process, he added.

Corporate health and wellness firm Wellness Coaches, one of Senzo's strategic investors that provided $500,000 in funding, chose to invest in the company because it believes the ALF technology "could be game changing," President Kristopher Wood said. There are "a bunch of potential applications" for the technology, and once the test gets approved, Wood said he believes "it will be the best test on the market." Wellness Coaches has sold more than 4 million COVID-19 tests and anticipates a "robust business partnership" with Senzo, potentially selling or administering its ALF assays, he said. 

"If this works, and every indication that we've seen so far is that it's going to work … it's addressing a large market, it's disrupting a large market," Wood said. "I think it's literally going to save lives."