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FDA Approves First At-Home Syphilis Test: Results in 15 Minutes
Syphilis Test: Results in 15 Minutes
Traditionally, syphilis testing involves sending a blood sample to a lab, with results typically taking hours to days. However, the FDA has now approved a new at-home syphilis test by NOWDiagnostics, named First-to-Know, which delivers results in just 15 minutes.
Harlo Launches 3-in-1 Electrolyte Drink
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Announced on Friday, this approval makes First-to-Know the first FDA-cleared over-the-counter, at-home syphilis test. Based in Springdale, Arkansas, NOWDiagnostics will market the test under the brand name "First-to-Know."
Syphilis is caused by the bacterium Treponema pallidum and can be treated effectively with antibiotics such as penicillin. If not addressed, it can lead to severe complications, including heart and brain damage, as well as blindness, deafness, and paralysis. The CDC has reported an 80% increase in syphilis cases from 2018 to 2022, reflecting a continuing trend of rising infections.
The First-to-Know test only requires a single drop of blood to detect antibodies against Treponema pallidum. The FDA's approval was supported by a clinical study involving 1,270 participants, which demonstrated a 99.5% negative percent agreement and a 93.4% positive percent agreement compared to three FDA-approved lab tests.
The FDA notes that, like other diagnostic tests, First-to-Know has risks of false positives and false negatives. Positive results should be followed by additional testing to confirm a syphilis diagnosis.
Dr. Gregory Bledsoe, former Surgeon General of Arkansas, underscored the need for greater awareness about untreated syphilis, especially in underserved populations. He believes that at-home tests like First-to-Know could greatly enhance public health by making timely detection and treatment more accessible.
3 healthy foods that attract belly fat
Are you turning healthy fruits into highly unhealthy fruits, without even realizing it?
Fruit can be one of the healthiest things you can put into your body, but the majority of Americans are guilty of making this single mistake that can counteract all of the health benefits of fruit.
Some fruits can help with occasional constipation, reduce bloating, and even help burn calories.
Others can wreak havoc on your digestive system and energy levels.
This doctor showcases the three fruits to stop eating today.
NOWDiagnostics, which specializes in over-the-counter and point-of-care diagnostic tests, reports that its technology allows for quick immunological assays using just a small blood sample. The company is also developing saliva tests and has more than 30 tests in its development pipeline, including those for pregnancy and Covid-19.
The FDA reviewed First-to-Know under the De Novo premarket review pathway, which is used for new devices with low-to-moderate risk. This approval sets a precedent for future similar tests to be evaluated using the FDA’s 510(k) pathway.
First-to-Know will soon be available without a prescription and is expected to hit retail stores and online platforms later this year. NOWDiagnostics has recently raised $22.5 million in Series B funding, led by DigitalDx Ventures, with participation from Labcorp Venture Fund and Kompass Kapital Management, to support the commercialization of First-to-Know.
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