SYPHILIS HEALTH CHECK™
Combating Syphilis With Innovative Breakthroughs In Rapid Diagnostic Testing

In the 1990s, syphilis, one of the oldest known sexually transmitted infections (STI), was nearly eradicated from the U.S. However, it is staging a tragic comeback. Dubbed the ‘great imitator’ for mimicking other diseases, the early symptoms of syphilis can be easily overlooked, making it potentially a fatal infection if left untreated. It is particularly alarming for pregnant women, who may transmit it to their fetuses, leading to congenital syphilis, which can cause severe disability or even death in newborns.


According to the Centers for Disease Control and Prevention (CDC), there was an 80 percent increase in reported syphilis cases in the U.S. between 2018 and 2022. Even more concerning is the tenfold increase in congenital syphilis among newborns. Health authorities are addressing this issue by calling for more frequent testing. The advent of point-of-care testing is a significant step forward in this regard, offering the potential for widespread screenings and reducing the time between testing and initiating life-saving treatments.

Syphilis Health Check™ is making syphilis screening seamless. Testing is conducted within minutes with just a fingerstick and one drop of whole blood. It is super easy, swift, and just two steps to deliver crucial results

At the forefront of this movement is Diagnostics Direct, LLC., a leader in the development and distribution of highly accurate, easy-to-administer and simple-to-read diagnostic test kits for syphilis. The company has transformed testing by introducing the Syphilis Health Check™ (SHC), the world’s first and only FDA CLIA-Waived 510(k)-cleared rapid syphilis only test. The innovative test uses a single drop of whole blood from a fingerstick or serum or plasma samples to detect Treponema pallidum antibodies, delivering results in 10 minutes with over 97 percent accuracy. This level of precision and convenience allows healthcare professionals to perform timely screenings with same-day treatment for patients on a larger scale, greatly improving the management and prevention of syphilis.

Heralding a New Era in Syphilis Testing

In the fight against syphilis, Diagnostics Direct is changing the testing paradigm with SHC. This innovative diagnostic tool detects IgM and IgG antibodies to Treponemal antigens and delivers highly accurate results across all stages of infection. Its premixed buffer streamlines the process by removing the need for multiple steps. SHC stands out for its user-centric design, which is particularly beneficial for pregnant women, given the risk of congenital syphilis when syphilis is not treated during pregnancy.

Unlike traditional, cumbersome diagnostic tests, SHC’s simplicity ensures that healthcare providers can conduct screenings without the usual complexities, including lengthy turn-around times. The real breakthrough is its use of fingerstick samples instead of time-consuming blood draws that require professional training. This method makes sample collection straightforward and less intimidating for patients while providing highly accurate results in ten minutes with patients present.

Jeff Tobias, COO and co-founder of Diagnostics Direct, emphasizes the efficiency of the SHC, saying, “Syphilis Health Check™ is making syphilis screening seamless. Testing is conducted within minutes with just a fingerstick and one drop of whole blood. It is simple, swift, and uses just two steps to deliver crucial results.”

Due to its CLIA-Waived status, healthcare facilities can perform rapid tests at the point of care, enhancing operational efficiency and delivering highly accurate results in ten minutes with the patient present. Its compact design makes it ideal for use in sexual health and prenatal clinics, urgent care, emergency departments, outdoor locations, and outreach events.

SHC’s impact extends beyond clinical settings into the community. The test is notable for its user-friendly design, precise performance, and affordability. Priced at $10 per test, it is a cost-effective solution, falling well within insurance reimbursement levels. Remarkably, the test can be used for adolescents as young as 13, ensuring comprehensive coverage across all demographics. This improved applicability fosters greater health accessibility and encourages individuals to take proactive steps in managing their health.

To maximize SHC’s benefits, Diagnostics Direct has developed on-demand training for healthcare professionals. The on-demand training ensures that providers can complete learning at their convenience and that they are proficient in performing the test. Each participant receives a certification upon completion, validating their capability to effectively use this innovative testing solution in various care scenarios.

The Syphilis Health Check™ is more than just a medical device; it is a pivotal contributor in the global effort to combat and prevent congenital syphilis. Diagnostics Direct envisions a future where testing is quick, non-intrusive and available to everyone, fundamentally changing the landscape of syphilis diagnosis and prevention.

Streamlining Syphilis Diagnosis

Diagnostics Direct’s introduction of SHC as a simpler alternative has garnered significant attention from the industry. The company has long been a leading provider of rapid syphilis testing, earning a significant market presence as one of the primary suppliers.

Dr. Irene Stafford from University of Texas Health Science Center in Houston, has studied the impact of SHC, proving its efficacy and potential to improve healthcare outcomes among pregnant women. Rigorous validation studies support SHC’s reliability, with results that consistently align with CDC standards and use rapid plasma reagin (RPR) as a benchmark. Testing programs in Houston have already detected several additional cases in just eight weeks. The scalability of such initiatives is crucial, considering the prevalence of syphilis across all U.S. states.

“Through strategic partnerships and targeted outreach initiatives, Diagnostics Direct aims to expand its reach and ensure its testing solutions are used to their full potential across diverse healthcare settings. We intend to increase awareness about the existence and effectiveness of such tests, which remain relatively unfamiliar to many,” says Norman Proulx, CEO, president and co-founder.

Diagnostics Direct is actively promoting the adoption of SHC, working with influential figures like Dr. Stafford, who has extensive connections in the medical community across the country. More available clinical data will provide compelling evidence of how increased screening efforts lead to better health outcomes for individuals and communities nationwide.

A Visionary Team for Transformative Initiatives

The most significant asset at Diagnostics Direct is not just the product or service but the expertise that propels its creation and growth. This expertise is embodied in the form of a well-assembled team of specialists who bring a wealth of experience from the healthcare industry.

United by a common goal to enhance healthcare delivery, these experts are relentless in their pursuit of developing dependable diagnostic solutions. This collaborative approach is evident in the leadership of the four co-founders—Tobias, Proulx, Janet Proulx, and Dr. Gary Lehnus. Their combined experience of over six decades in Diagnostics Direct is the driving force behind its success.

Dr. Gary Lehnus adds a unique dimension to this leadership team. Renowned in the medical field, Dr. Lehnus has over 30 years of experience in syphilis testing devices and has developed FDA-cleared syphilis devices. His involvement is evident in Diagnostics Direct’s commitment to pioneering advances in diagnostics.

Supporting the core team is an esteemed medical advisory board composed of leading experts whose vision aligns with the CDC’s urgent call for collaborative efforts among all STI prevention partners. Their objective is to curb the spread of syphilis with innovative, accessible testing solutions like those developed by Diagnostics Direct.

The medical advisory board is led by Dr. Jeffrey Klausner, a globally recognized clinical professor at the Keck School of Medicine, USC. His extensive experience in medicine, infectious diseases, and public health is invaluable to Diagnostics Direct’s mission. He is joined by Dr. Leandro Mena, former Director of the Division of STD Prevention at the CDC, who is known for his commitment to improving sexual health. Dr. Irene Stafford, a board-certified maternal and fetal specialist at the University of Texas Health Science Center in Houston, brings crucial expertise in addressing congenital syphilis.

The collective experience of the team and advisory board has placed Diagnostics Direct at the forefront of healthcare diagnostics innovation. The company is currently focused on addressing significant gaps in screening protocols for congenital syphilis and securing FDA authorization. Its groundbreaking technology is set to transform the immediate detection of health problems in infants.

Diagnostics Direct’s impact is clear—over 30,000 SHC tests were donated by the end of 2023, and six million tests have been sold in the U.S. This achievement has democratized access to STI testing, building a narrative of empowerment and transformation in public health. The company’s influence is poised to resonate with millions across the nation, fostering a healthier and brighter future for generations to come.