Frequently Asked Questions

The Personal Pap Smear™ (PPS) is the world's first patented cervical cell collection device designed for self-administration. It allows women to collect cervical cell samples in the privacy of their own home or within a healthcare setting.

The PPS was developed to help make cervical cancer screening more convenient, accessible, and comfortable for women.

Many self-sampling methods currently available collect vaginal cells primarily for HPV testing.

The Personal Pap Smear™ (PPS) is specifically designed to collect cervical cells, which may be analyzed for:

• Cervical cytology
• Human papillomavirus (HPV)
• Chlamydia
• Gonorrhea

This focus on cervical cell collection is one of the key differentiators of the PPS.

GyneConcepts developed the PPS after recognizing that many women continue to delay or avoid routine screening because of factors such as:

• Discomfort
• Embarrassment
• Privacy concerns
• Scheduling difficulties
• Cost concerns
• Limited access to care

The PPS was designed to help remove many of these barriers and encourage greater participation in cervical cancer screening.

Yes.

The Personal Pap Smear™ (PPS) was designed to allow women to self-administer cervical cell collection in the privacy of their own home or within a healthcare setting.

No.

The PPS was designed with simplicity in mind and features a straightforward collection process intended to make cervical cell collection more accessible and user-friendly.

Cervical cancer is one of the most preventable forms of cancer when detected early.

Routine screening helps identify abnormal cellular changes before they develop into cancer or before cancer progresses to advanced stages.

Early detection remains one of the most effective tools for protecting women's health.

Nearly all cervical cancers are associated with persistent infection from certain high-risk types of Human Papillomavirus (HPV).

Routine screening helps identify changes that may require medical evaluation before cancer develops.

Yes.

One of the challenges with cervical cancer is that symptoms may not appear until the disease has progressed.

Routine screening helps identify abnormalities before symptoms develop.

Always consult your healthcare provider regarding recommended screening schedules.

No.

The HPV vaccine provides important protection against several high-risk HPV strains, but regular cervical cancer screening remains an important part of preventive healthcare.

Women should continue following screening recommendations provided by their healthcare provider.

Screening recommendations vary based on:

• Age
• Medical history
• Previous screening results
• HPV status
• Individual risk factors

Women should consult their healthcare provider regarding the screening schedule that is most appropriate for their situation.

A Pap Smear examines cervical cells for abnormal changes.

An HPV test looks for high-risk HPV infections that may increase the risk of developing cervical cancer.

Both tests provide valuable information and may be used independently or together depending on screening recommendations.

A co-test combines:

• A Pap Smear
• An HPV test

This approach allows healthcare providers to evaluate both cervical cell abnormalities and HPV status.

Cervical cells can be examined for abnormal changes that may indicate:

• Precancerous conditions
• Cervical dysplasia
• Early cervical cancer

Direct cervical cell collection remains an important component of cervical health screening.

Yes.

GyneConcepts is actively conducting clinical research related to the Personal Pap Smear™ (PPS) and is recruiting participants in the Atlanta, Georgia area.

Clinical research helps evaluate innovative healthcare technologies and supports the advancement of new approaches to patient care.

Research is an important step in improving healthcare options for future generations.

Current recruitment efforts are focused on:

• Atlanta
• Sandy Springs
• Roswell
• Alpharetta
• Marietta
• Surrounding Metro Atlanta communities

You can contact GyneConcepts directly to learn more about current eligibility requirements and participation opportunities.

Yes.

The PPS is protected by multiple U.S. patents, including:

• U.S. Patent No. 8,460,209 B2
• U.S. Patent No. 8,672,861 B2

Additional international patent protection extends across multiple countries and regions.

Yes.

The Personal Pap Smear™ (PPS) has achieved CE registration in the European Union as a Class I Non-Sterile Device.

Patent protection includes:

• United States
• Canada
• Australia
• New Zealand
• South Africa
• Russia

European patent validations include:

• France
• Germany
• Italy
• Netherlands
• Spain
• Sweden
• United Kingdom

GyneConcepts is a female-led, privately held women's health company dedicated to making medical testing and treatment more convenient, affordable, accessible, and psychologically comfortable for women worldwide.

GyneConcepts, Inc.

375 Thornwood Drive, N.E.

Atlanta, GA 30328 USA

Our mission is simple:

To make medical testing and treatment more convenient, affordable, accessible, and psychologically comfortable for women worldwide.

We are committed to advancing technologies that help women take a more active role in their preventive healthcare.

It reflects our vision of a future where women have greater access to healthcare solutions that support early detection, convenience, privacy, and confidence.

Every innovation we pursue is guided by that goal.