NOWDiagnostics First To Know® Syphilis Test Receives FDA De Novo Marketing Authorization for Over-the-Counter Use
August 16 2024 - 11:58AM
Business Wire
First and only rapid syphilis test with in-home
results in minutes, addressing growing epidemic
NOWDiagnostics, Inc. (NOWDx), a developer of over-the-counter
(OTC) and point-of-care (POC) diagnostic tests, today announced
that the U.S. Food and Drug Administration (FDA) has granted
marketing authorization to its First To Know® Syphilis Test for OTC
use. First To Know® is the first and only rapid syphilis test in
the U.S. that provides an in-home result in 15 minutes with a
single drop of blood. It has been proven in a clinical study of
1,270 people to be easy to use. The test received marketing
authorization from the FDA through the de novo pathway, recognizing
it as a novel device for syphilis testing in the United States,
distinguishing it from other products on the market.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240816394389/en/
First To Know® Syphilis Test (Photo:
NOWDx)
Syphilis has resurged at an alarming rate in the U.S. in nearly
every demographic group and region, including newborns. According
to the Centers for Disease Control and Prevention (CDC), cases
increased by 80% to over 207,000 between 2018 and 2022. More than
3,700 cases of congenital syphilis were documented among newborns
in 2022—10 times the number diagnosed in 2012. If untreated,
syphilis can seriously damage the heart and brain and cause
blindness, deafness, and paralysis. When transmitted during
pregnancy, it can cause miscarriage, lifelong medical issues, and
infant death. Often, those with syphilis do not notice
symptoms.
“FDA granting De Novo authorization of our First To Know®
Syphilis Test could not have come at a more important juncture in
our country’s efforts to slow the rise of syphilis,” said Rob
Weigle, CEO of NOWDx. “Testing is one of the most important tools
we have in preventing the spread of sexually transmitted
infections, and for the first time ever, consumers now have a fast
and simple syphilis test that can be performed in the privacy of
one’s home, with a result in minutes.”
"This FDA authorization is a significant milestone in addressing
the syphilis epidemic," said Dr. Gregory Bledsoe, MD, MPH, MBA,
former Surgeon General for Arkansas. "After reviewing the robust
data from the clinical studies, I am impressed with the test's
performance. There is a critical need to increase public awareness
about the seriousness of untreated syphilis, especially in
underserved and marginalized populations. An in-home test like this
has the potential to greatly impact public health by improving
access to timely detection and treatment."
About First To Know® Syphilis Test
The First To Know® Syphilis Test is a patented buffer-less
lateral flow device that provides a qualitative rapid membrane
immunochromatographic assay for detecting Treponema pallidum
(syphilis) antibodies in human whole blood (capillary) from
individuals suspected of having a syphilis infection. In a clinical
study of 1,270 people, the NPA (negative percent agreement) was
99.5%, meaning it correctly identified 99.5% of negative specimens;
the PPA (positive percent agreement) was 93.4%, meaning it
correctly identified 93.4% of positive specimens when compared to
three FDA cleared laboratory tests.
First To Know® Syphilis Tests are expected to be available at
major national retailers and online in the second half of 2024.
*For more information, visit www.firsttoknow.com.
About NOWDiagnostics (NOWDx)
NOWDx develops and manufactures over-the-counter (OTC) and
point-of-care (POC) diagnostic tests. Its patented approach enables
virtually any immunological assay to be accurately performed onsite
in one step using a small amount of capillary blood, yielding
results in minutes. With over 75 patents issued and pending,
NOWDx's First To Know® and ADEXUSDx® product lines are available in
markets worldwide. Founded in 2013, with headquarters and
manufacturing in Springdale, Arkansas, NOWDx envisions a world
where people have greater access to in-home testing with results in
minutes. The company’s investors include Kompass Kapital
Management, DigitalDx Ventures and the Labcorp Venture Fund. NOWDx
is committed to changing healthcare by providing accessible,
affordable, and accurate testing for all. Please visit nowdx.com
for more information.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240816394389/en/
Alexander Romero-Wilson Health+Commerce (for NOWDx)
alexander@healthandcommerce.com