Dermatophyte infection (onychomycosis and tinea capitis)

Dermatophytes are a group of pathogenic fungi (predominantly from the Trichophyton and Microsporum genera) that infect the nails, skin, and hair. Dermatophyte infection of the nails results in onychomycosis (fungal nail infection), while dermatophyte infection of the hair and scalp results in tinea capitis (ringworm of the scalp). Onychomycosis is a widespread disease that is particularly common in the elderly and has the greatest potential for severe consequences in diabetic patients. Tinea capitis is a pediatric disease that disproportionately affects children from socioeconomically disadvantaged backgrounds and sub-Saharan African descent. For both diseases, rapid diagnosis is critical for promptly initiating the correct antifungal treatment.

Diagnostic challenges

The current gold standards for diagnosis of onychomycosis and tinea capitis are microscopy and fungal culture. Microscopy requires a high degree of skill, is expensive and is most often done on samples that have been shipped to reference laboratories, which means results take several days. Fungal culture also requires sending a sample to a reference lab, and results are generally not available for 2-4 weeks. Consequently, many doctors diagnose the infection based on the patient’s clinical presentation alone. But because the symptoms of onychomycosis and tinea capitis are difficult to distinguish from other disorders, many patients with dermatophyte infections fail to receive appropriate anti-fungal treatment, while other patients without dermatophyte infections unnecessarily receive anti-fungal drugs.

It is critical to get the diagnosis and treatment plan right. Failure to provide anti-fungal treatment to patients with dermatophyte infections can result in more severe disease for the patient and continued disease transmission in the community. Conversely, incorrectly prescribing anti-fungal drugs to patients without dermatophyte infections can result in unnecessary risk exposure, because the particular anti-fungals used to treat these diseases are oral drugs that must be taken for weeks and have potential for serious systemic side effects.

DxDiscovery solution

Our solution is to produce a point-of-care diagnostic for dermatophyte infection of the hair and nails that is rapid (<20 min), accurate, and affordable, as well as suitable for use in resource-limited settings. The goal is to correctly diagnose onychomycosis and tinea capitis during the patient’s clinic visit, so that patients can receive prompt, appropriate treatment and return to their daily lives.

The target population will be all patients who present to the clinic with symptoms of potential onychomycosis or tinea capitis. The product will be a rapid and inexpensive lateral flow immunoassay (similar in format to that of the rapid test for strep throat) that will directly identify the presence of dermatophyte fungi in nail, hair, and skin specimens. A positive result would trigger immediate treatment.

Market opportunity

In the United States, approximately 11M adults are affected by onychomycosis every year. An additional 3M children in the U.S. are affected annually with tinea capitis.

R&D funding

DxDiscovery has been awarded Small Business Innovation Research (SBIR) Phase I and Phase II grants from the National Institute of Biomedical Imaging and Bioengineering for development of the dermatophyte diagnostic.

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