BioCard™
BioCard™ HSV-2 Kit
Uncovering the hidden epidemic with confidence and speed
In the USA, herpes simplex virus type 2 (HSV-2) affects an estimated 60 million people , with a 90% remaining undiagnosed due to a combination of access to accurate diagnostics and lack of education. As the primary cause of genital herpes, HSV-2 continues to be underdiagnosed and misunderstood leaving millions untreated, misdiagnosed, or burdened by unclear test results. Despite its high prevalence and public health impact, commonly used diagnostics fall short in delivering the speed, clarity, and accuracy clinicians and patients require. Astonishingly, around 22% who are tested in the USA are given an equivocal result, leaving them unaware if their infected or not.
Whilst the disease is synonymous as being an STI, for infants born by natural birth, infection is a risk during the labour process, needlessly transfer the infection, when pregnant women could be immediately screened and appropriate measures taken.
Given the BioCard does not need sample so be sent to centralised laboratories, access to “gold standard” testing is possible in any clinic, drug store, pharmacy or drop in centre.
The diagnostic gap
An estimated 60 million Americans are living with genital herpes, yet 90% remain undiagnosed due to mild or absent symptoms. Overall, around 13.2% of U.S. adults aged 14–49 are infected with HSV-2, according to the CDC. However, modelling factoring past studies with transitioned demographic shifts results in a peak infection rate of 29-31%* in those aged 55 to 74 years of age.
The CDC cites a study (Herpes – STI Treatment Guidelines) which reports a specificity of 39.8% for index values of 1.1–2.9 when relying on the HerpeSelect® HSV-2 IgG ELISA. This potentially leads to false positives, unnecessary antiviral prescriptions, and patient distress. While Western Blot testing offers greater accuracy it is not FDA approved for infectious diseases, it is slow, expensive, and not widely accessible.
These factors created a clear need for rapid, reliable confirmatory testing at the point of care, which is equally capable as an ultra rapid screen.
Why BioCard™ is different
BioCard™ HSV-2 is a unique immunoassay designed to immediately and accurately confirm HSV-2 status in laboratory settings, but is equally accessible at the point of care.
Delivering results in just 3 minutes without the need for any laboratory equipment, it is reimbursable under CPT Code 86696 and is CDC-recommended for confirming low-positive ELISA results. With FDA clearance and CE marking, BioCard™ seamlessly integrates into the workflows of STD clinics, hospitals, public health labs, and OB/GYN offices, providing timely results where they matter most.
Who should be tested?
Adults aged 55 to 74 represent the group with the highest prevalence of HSV-2 infection, 31%, with women being more susceptible due to biological factors.
African American populations experience higher infection rates 34.6%, and the Southern United States carries a greater disease burden. Additionally, approximately 2.45 million pregnant women in the U.S. are screened before vaginal delivery to manage and reduce transmission risks, however not currently using the CDC recommend technology for more accurate results.
Accuracy you can trust
BioCard™HSV-2 Kit is included in the CDC’s STD Treatment Guidelines as a recommended supplemental test to confirm equivocal HerpeSelect® ELISA results.
Applying the CDC recommended methodology improves screening accuracy to 98.7% specificity when equivocal results are reflex tested on the BioCard™HSV-2 Kit. Improving HSV-2 testing accuracy, improves patient care, helps avoid unnecessary antiviral treatments and enhances diagnostic confidence.
Screening negatives on the BioCard™HSV-2 Kit and confirming results between 8 and 12 weeks later, represents a further advancement in HSV-2 testing. This approach reflects that patients immune response to very recent infection increases over time, and can be confirmed utilising a stronger sample at a later time point.
Individually, studies demonstrate that BioCard™ offers up to 98% specificity*, performs ideally in the low-positive ELISA range, and eliminates the need for routine Western Blot confirmation.
*https://www.uspreventiveservicestaskforce.org/home/getfilebytoken/aHpXYasjc3n6zhaTtoWMwK
*https://pmc.ncbi.nlm.nih.gov/articles/PMC1276011/
The market opportunity
Nationally, factoring differences in age bands utilising the CDC backed dynamic model by Ayoub et al. (2021), we attain an estimate of 59.7 million Americans who would attain a positive test result if screened.
Out of the entire cohort tested for HSV-2 only 13.2% are found to be positive for the disease. (National Health and Nutrition Examination Survey – NHANES), however as noted above this is significantly different when demographic data is more granularity analysed.
For every test sold, deemed positive, a further 7 tests are sold to people who test negative. Consequently, aside from the 47.76 American’s already infected and as yet untested, of the 572,000 new infections per year some 4.6M HSV-2 would be required to screen new infections, with around 22% (1 million tests) recommended to be confirmed using the BioCard™ technology under the CDC guideance.
Clinical & commercial benefits
By eliminating ambiguity, or abject absence of a HSV-2 diagnosis, BioCard™ reduces patient anxiety and prevents unnecessary prescriptions. It helps clinicians avoid over-treatment and reduces the risk of re-admission related to missed or misdiagnosed infections ultimatly reducing the burden on healthcare and wider resources. Optimising diagnostic workflows generates reimbursable revenue with minimal operational overhead, making it a valuable asset for any clinical setting.
Interested in distributing BioCard™ HSV-2?
Help bring clarity to millions living with undiagnosed HSV-2. The BioCard™ HSV-2 Rapid Test delivers accurate, lab-quality results in minutes without lab infrastructure. If you’re a distributor ready to expand your diagnostic portfolio with a clinically validated, CDC-recommended product, we’d love to hear from you. Join our mission to transform sexual health diagnostics across clinical, public health, and telehealth sectors.
