New 10-Minute Syphilis Test Aims to Revolutionize Diagnostics

STONE HARBOR, N.J. – May 19, 2026 – In a significant step toward combating a resurgent public health crisis, New Jersey-based Diagnostics Direct LLC has received a prestigious innovation award from the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases (JH-CIDID). The award, which includes up to $150,000 in funding, is set to accelerate the development of a groundbreaking 10-minute, point-of-care test for syphilis that could fundamentally change how the disease is diagnosed and treated.

The novel test is designed to be the first of its kind to be both FDA-cleared and CLIA-waived, simultaneously detecting the two distinct types of antibodies needed for a definitive diagnosis of an active syphilis infection. This breakthrough could empower healthcare providers to test and treat patients within a single visit, a critical advancement in the fight against sexually transmitted infections (STIs).

A New Weapon Against a Resurging Disease

The need for such an innovation has never been more urgent. Syphilis rates in the United States and across the globe have been surging at an alarming rate. According to the Centers for Disease Control and Prevention (CDC), cases have reached their highest levels in decades, with a particularly devastating rise in congenital syphilis, where the infection is passed from mother to child during pregnancy, leading to stillbirth, infant death, and lifelong health problems.

Currently, the standard diagnostic process is a major bottleneck. It relies on a two-step serological algorithm that requires blood samples to be sent to a laboratory. The process involves testing for both treponemal antibodies, which indicate a past or present infection, and nontreponemal antibodies, which typically signify an active, treatable infection. This multi-day delay between testing and results creates a dangerous window where infected individuals can unknowingly transmit the disease. Furthermore, it presents a significant barrier to care, as patients—especially those in vulnerable or underserved communities—may not return for a follow-up appointment to receive their results and begin treatment.

While some rapid treponemal-only tests exist, they cannot distinguish between an active infection and one that was successfully treated years ago, as treponemal antibodies can persist for life. This limitation necessitates a confirmatory nontreponemal lab test, negating much of the benefit of a rapid initial screen.

The Science of a Single-Visit Solution

Diagnostics Direct's test aims to solve this long-standing diagnostic dilemma by integrating both tests onto a single, rapid platform. The primary technical hurdle has always been the difficulty of achieving the high sensitivity required for the nontreponemal component while suppressing non-specific binding that leads to false-positive results. Overcoming this challenge is the core of the company's innovation.

By providing both a treponemal and nontreponemal result at the patient's side in just 10 minutes, the test would enable a true "test-and-treat" model. A provider could confirm an active infection and immediately administer the necessary penicillin treatment, breaking the chain of transmission and preventing the severe long-term complications of untreated syphilis.

"We are honored to be selected for an innovation award by the Johns Hopkins Centers for Innovative Diagnostics for Infectious Diseases to accelerate the development of our treponemal / nontreponemal syphilis test," said Norman Proulx, CEO of Diagnostics Direct, in a recent statement. "This test represents a meaningful advancement in syphilis testing that will enable healthcare providers to test and treat immediately without having to send samples out for additional serology testing. This is especially significant in situations where patients may not return for results or follow-up care."

Validation from a Leader in Innovation

The award from JH-CIDID is more than just funding; it is a powerful endorsement from a world-renowned institution. Founded in 2007 and embedded within Johns Hopkins University, JH-CIDID is dedicated to accelerating the development of impactful infectious disease diagnostics, particularly low-cost technologies for use in both the U.S. and low-resource settings globally.

The center is a key part of the Point-of-Care Technologies Research Network (POCTRN), a program established and funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH). This network has a proven track record, most notably through the RADx® Tech program during the COVID-19 pandemic, which dramatically accelerated the development and deployment of rapid tests. The center notes that companies it has partnered with have gone on to raise over $350 million in follow-on funding, a testament to its ability to identify and nurture promising technologies.

Diagnostics Direct was one of six recipients of the 2025 JH-CIDID innovation awards, selected for its potential to expand the use-cases for point-of-care STI tests.

The Path to Market and Public Health Impact

With the backing of Johns Hopkins, Diagnostics Direct will continue to advance its test through the rigorous development and validation process required to secure FDA clearance. A critical milestone will be achieving a CLIA waiver, which certifies that a test is simple enough to be performed accurately in non-laboratory settings like doctors' offices, community health clinics, and emergency rooms by staff with minimal training. This waiver is essential for realizing the test's full potential for widespread, equitable access.

The potential public health impact is immense. By moving definitive diagnosis out of the centralized lab and to the patient's side, the technology could dramatically improve screening programs for pregnant women, a key strategy for eliminating congenital syphilis. It would also enhance care for other high-risk populations and in rural areas where access to laboratory services is limited.

In a market valued at over $1.5 billion and growing, a successful dual-action rapid test would represent a significant commercial opportunity. But more importantly, it holds the promise of transforming a slow, multi-step diagnostic process into a single, decisive action, offering a powerful new tool to finally turn the tide against this ancient and increasingly prevalent disease.