The company hopes to bring the test to market by the second half of 2023
Current testing for most diagnostic applications is slow, inefficient, and expensive, which contributes to massive under-diagnosis, under treatment, and worse healthcare outcomes. Patient diagnosis is delayed, or doesn’t happen at all, while the healthcare provider’s time is wasted, there’s an increased spread of disease, not to mention high costs and unhappy stakeholders. It’s bad for everyone.
Senzo is looking to close this gap by developing high accuracy, low-cost point-of-care diagnostic technologies. Its Amplified Lateral Flow (ALF) platform combines the speed and low cost of lateral flow tests with the accuracy of PCR tests, Jeremy Stackawitz, CEO of Senzo Health, explained to VatorNews
“Our test will be simple to use, with no training, readers, instrumentation required. We will also have a technology envelope supporting the device, creating a digital platform which is activated via reading a QR code that can then capture and report results, go into electronic patient records, get live support, connect you through to a physician for test-to-treat,” he said
On Monday, the company announced a $1.9 million investment led by existing investors BioAdvance and Wellness Coaches, bringing its total funding to $7.7 million following a $3.9 million round in June of this year.
To use Senzo’s test, patients just need to collect a nasal swab sample, then add the sample to the buffer and test, and wait for a control line to appear. Then they attach an amplification applicator and depress it to add the solution, after which they’ll see their results.
The intent is for most of the company’s tests to be offered both over the counter and to professional users, though Stackawitz noted there may be some applications that only make sense to be used by professionals, such as in-hospital tests for MRSA and C.Diff.
“We have not yet launched our first product but anticipate selling to retailers for DTC/home-use, through government testing contracts, employers, school districts, universities, as well as through professional users such as clinics, pharmacies, hospitals,” he explained.
“In some cases, it’s getting testing to those who wouldn’t do it otherwise, like STDs, Hep C, tuberculosis, in some cases it’s making it easier and faster to reach a diagnosis so that you can take action, such as therapy, like strep, influenza, etc.”
The new funding comes after blinded studies by UCL and LateralDx, which shows that the ALF test had 98% accuracy in comparison to PCR in correctly identifying COVID-19 virus in samples, even at very low viral loads.
The investment will be used to complete validation, execute clinical trials, secure FDA EUA authorization, and scale manufacturing for the ALF COVID-19 test. The plan is to complete ALF COVID-19 clinical trials and secure FDA EUA regulatory approval in the first half of 2023, with tests commercially available in the second half of 2023.
The money will also be used to expand the test into new testing areas, with additional R&D for new Flu A/B, RSV, Tuberculosis, HIV, is hepatitis-C, and strep.
“In general infectious diseases are a good fit for our platform because they only require qualitative, meaning yes/no, results, unlike lipids or enzyme levels. A respiratory triplex for COVID-19/FLU/RSV will help you tell what you have or don’t have in one easy test,” said Stackawitz.
Ultimately, the company’s goal is to leverage this technology to bring a double-digit number of products to market worldwide, and to make a genuine improvement in how disease is diagnosed, thus improving patient outcomes and reducing system costs along the way.
“There are probably over 20 tests that will make sense for this platform, it’s just a matter of prioritizing,” Stackawitz said.
“We have made a lot of progress on ALF in only around 18 months, and we are getting a lot of traction with potential technology partners, customers, investors, healthcare professionals, commercial/distribution partners. We’re very excited about partnering in a variety of different ways.”
Discovered on: 2022-12-13 13:00:00
Source: Point-of-care diagnostic company Senzo raises $1.9M