Onko Solutions has developed InstaPAP® a portable medical device for effective, reliable, fast and non-invasive screening for cervical cancer that unlike Pap smears, HPV tests, or biopsies, does not require laboratory analysis or a tissue sample.
Our device provides non-invasive screening with instantaneous results, eliminating costly, painful and unnecessary lab work.
Processing COFEPRIS approval
The predominant method of screening for cervical cancer is the Papanicolaou test, during which a doctor swabs the cervical surface to collect cells that are then examined on a pathology laboratory by a licensed cytotechnologist using specialized equipment. If an abnormality is found, a cytopathologist verifies the interpretation. Not only is a Pap smear intrusive, expensive and lengthy -it may take up to three weeks to get the results- but it is also fallible. The rate of false negatives and false positives is disappointingly high, in some instances reaching nearly 60%.
We have developed a low-cost, portable, minimally invasive solution that easily fits into a technician’s hand. Furthermore, our device allows the test to be administered by a nurse, medical technologist, or itinerant semi-skilled medical personnel producing instant results even on unusual conditions.
With a sensitivity greater than 85% this low-cost test that requires no lab work is a significant advance in women’s healthcare.
THE TECHNOLOGY BEHIND OUR PRODUCT
Our device combines multiple technologies leveraging Intelligent systems based on neural networks and support vector machines, including optical spectroscopy and electrical impedance, an increasingly important field in the area of cancer prevention and diagnosis. The latter is especially valuable because it provides several advantages over cytology including immediate results and the inclusion of artificial intelligence to improve the collection, dissemination and visualization of results during the screening of cancerous cells in-vivo. Our device combines a set of features offering a superior solution that is minimally intrusive, portable, and inexpensive, while providing immediate, high-quality results.
Our device examines different areas of cervical tissue, taking electrical measurements from same in different frequency ranges and optical measurements in three different wavelengths. Once the measurements have been obtained, they are processed by a configurable device or micro-controller in accordance with mathematical formulas obtained from multiple measurements taken from healthy and cancerous tissues. Three possible responses can be obtained from the processing of the measurements: healthy tissue, cancerous tissue or the presence of human papilloma virus.
WHAT MAKES OUR TECHNOLOGY UNIQUE
● Our technology is safe and secure.
● Unlike current technologies, it provides immediate results.
● Its intelligent system is based on neural networks and support vector machines.
● The screening is non-invasive.
● It does not requite a specialist to interpret the results.
● It combines optical spectroscopy and electrical impedance.
● It offers superior levels on sensitivity and specificity.
Electrical and optical spectroscopy are useful for early detection and diagnosis of cancer cells because the identification of various cell types is based on the response to an electrical stimulation and/or the intensity of light on said cells.
The response to this stimulus depends on the structure and components of the cells. For instance, biological tissues have a characteristic electrical impedance which is a function of the frequency at which it is stimulated.
- Medical device suppliers
- Cervical cancer early detection
- Point of care detection
- Women's healthcare
AN INNOVATIVE SOLUTION TO CANCER DETECTION
TruScreen is a new technology used to detect pre-cancerous change, or cervical intraepithelial neoplasia (CIN), by optical and electrical measurements of cervical tissue.
TruScreen is an objective, self-checking digital system that can be used with minimal training, and without the infrastructure and resource costs associated with cytology-based screening.
As well as high accuracy, TruScreen provides an instant report and a more humane approach to women than a Pap test because no cervical tissue needs to be taken during the test.
The device comprises a hand piece, console and a single use sensor. Tissue stimulation and sensor elements are located in the tip of the hand piece probe, which is connected by cable to the console where software classifies the tissue.
FEATURES AND BENEFITS
No lab facility needed.
Automated device and error-checking during examination.
No need to collect tissue samples.
Immediate feedback to patient and operator.
Same result every time.
Easy to use.
Assured level of performance.
High standard of cervical screening.
Consistent and accurate results.
No pain or discomfort to the patient.
Patient can be treated if necessary at time of visit.
Reproducible, consistent results.
No qualified cytologists needed.
Suitable for remote areas and developing countries.
Economic savings to the healthcare system.
PRINCIPLES OF TRUSCREEN
Unlike cytology, TruScreen® does not only examine surface epithelial cells. Light at specific frequencies is transmitted through cervical tissue identifying changes in the basal and stromal layers. This includes increases in blood circulation and variations in blood vessels that occur with pre-cancerous change.
The TruScreen® system also assesses the electrical properties and response of the tissue. The electrical measurements are stimulated by the delivery of a very small impulse (about one volt) in millisecond pulse sequences that repeat 14 times per second. The decay response curve will vary according to the capacitance of the tissue – a measurement of the ability of the tissue to either hold or dissipate a charge. Different tissue types and the properties of the tissue have different capacitance.
The console has a microcomputer to calculate these tissue differences, and the results are compared to an integrated database of 2,000 patients from wide geographic and ethnic backgrounds with differing histological diagnoses. A sophisticated algorithm framework has been developed to distinguish between normal and abnormal (cancerous and precancerous) tissue.
A single use sensor with precision lens and electrodes are used to interface with the cervix and protect against cross-infection. A simple series of lights (similar to traffic lights) guides the operator to place the probe on new spots across the cervix.
CLINICAL PERFORMANCE AND STUDIES
TruScreen® has been extensively tested in numerous studies around the world, with results showing its performance is equal to, or better than, high quality cytology tests within the same study.
Across all studies, the performance of TruScreen® was consistent and equal to, or better than in some studies, the comparing high quality cytology tests within the same study. In one multi-centre study, TruScreen® was shown to detect precursors of cervical cancer (CIN 1-3) at an equivalent sensitivity to a top quality Pap smear. Ongoing studies confirm this performance.
Since TruScreen® results come from an objective, self-checking digital system, they are free of the highly subjective human judgment required for cellular diagnosis on conventional Pap smears.
TruScreen® can be effectively used with minimal training of medical or paramedical staff to allow cervical cancer detection without the infrastructure and resource costs associated with cytology based screening. TruScree®n is also more acceptable to women than a conventional Pap test and women strongly prefer access to an immediate result.
A comparative study between use of the TruScreen® and the conventional Pap test at the Whittington hospital in London showed that TruScreen® was associated with significantly less pain, pressure and scraping than experienced with the spatula or brushes used to collect cells from the cervix in cytology based screening.
In the last few years, TruScreen® has intensively validated its cervical screening system in many countries including Australia, Italy, UK, Poland, China, Indonesia and Korea.
TruScreen, Ltd has established a distribution network covering China, Vietnam, Pakistan, Indonesia, Philippines, Poland, Bulgaria, Romania, Russia, Turkey and Mexico. Clinical use of TruScreen in these countries has commenced and is now in a fast growth phase.
The global market potential for TruScreen is huge. At saturation, hundreds of millions of women will benefit from this accurate and inexpensive cervical cancer screening method.
The single most important potential benefit from the global commercialization of TruScreen is the saving of human life – and especially the lives that will be saved in the developing world.
FREQUENTLY ASKED QUESTIONS
What is TruScreen®?
TruScreen® is a real-time, accurate cervical screening tool for the detection of pre-cancerous and cancerous cervical cells. As well as being highly accurate, the TruScreen® system provides an instant report, thus preventing the risk of losing contact with the patient because of the delay associated with transportation of samples to laboratories for analysis and reporting. TruScreen® is an objective, self-checking digital system that can be used with minimal training of medical or paramedical staff, and without the infrastructure and resource costs associated with cytology-based screening.
WHAT IS THE NEED FOR A NEW CERVICAL SCREENING TEST?
Medical professionals around the world were looking for a real-time screening device to improve accuracy and patient follow up, reduce patient discomfort and the need for supporting laboratory infrastructure and make cervical screening more available to women in remote and undeveloped regions. Feedback from medical professionals also highlighted that current laboratory Pap tests are subjective and vary significantly – only giving approximately 50% accuracy.
WHY SHOULD PATIENTS ASK FOR A TRUSCREEN® EXAMINATION?
TruScreen® provides immediate results at the time of the visit, so that any necessary decisions about treatment or management can be made there and then, without the need for follow up information or a consultation. Also, as a medical device, the results are consistent and objective every time, and have been shown to be more acceptable to women because the TruScreen® test is painless and involves minimal discomfort.
HOW DOES TRUESCREEN® WORK?
A pen-like wand touches various spots on the cervix to pick up electrical and optical signals (14 readings per second) from the cervical tissue. The TruScreen® console collects this data and compares it to known tissue signatures to provide a result. This enables the physician to immediately plan appropriate patient care. TruScreen® examinations are painless.
HOW LONG DOES A TRUESCREEN® TEST TAKE?
Each TruScreen® examination takes approximately 1–2 minutes. Real-time results are then available immediately.
What clinical trial publications support the use of TruScreen®?
Numerous clinical publications support the use of TruScreen. Continual and ongoing field evaluations also support the consistent performance of TruScreen.
TruScreen has been extensively evaluated and used on more than 50,000 women globally. Studies have involved women from Australia, Brazil, Italy, Philippines, People’s Republic of China, Russia, Singapore, South Africa, Spain, United Kingdom and the United States of America.
TruScreen has been shown to detect cervical cancer and its precursors just as frequently as a top quality conventional Pap test. As well as high accuracy, TruScreen provides an instant report, thus preventing the risk of losing contact with the patient because of the delay associated with transportation of samples to laboratories for analysis and reporting.
A comparative study between use of TruScreen and the conventional Pap test at the Whittington Hospital in London showed that TruScreen was associated with significantly less pain, pressure and scraping than experienced with the spatula or brushes used to collect cells from the cervix in cytology based screening. Women also strongly preferred access to an immediate result.
The following are some of the publications that support and validate the use TruScreen.
A real time optoelectronic device as an adjunct to the Pap smear for cervical screening: A multicentre evaluation – A Singer & Associates Department of Gynecology, The Whittington Hospital London – Published by the International Journal of Gynecological Cancer 2003. Click here to read.
Evaluation of a real-time, optoelectronic device ‘TruScreen’ as a primary screening tool for cervical cancer – ZHANG Wei & Associates, Centre of early diagnosis and early treatment for Cervical Carcinoma, Shenzhen Hospital of Beijing University, Shenzhen 518036, China – 2007. Click here to read.
The evaluation of a real-time optoelectronic method for the detection of Cervical Intraepithelial Neoplasia (“CIN’) – Pruski D. & Associates, Gynecological Oncology Division, Department of Gynecology, Obstetrics & Gynecological Oncology, Poznan University of Medical Sciences, Poland 2008. Click here to read.
A real-time optoelectronic device in screening of cervical intraepithelial neoplasia – Sung Jong Lee, MD & associates Department of Obstetrics and Gynecology, School of Medicine, Catholic University, Seoul, Korea – Published in the Journal of Women’s Medicine, Korean Society of Obstetrics and Gynecology March, 2009. Click here to read.
Optoelectric Scanner TruScreen in Diagnostics of Cervical Squamous Intraepithelial Lesions – Sukhikh G.T. & Associates, Federal State Scientific Centre of obstetrics, gynecology and perinatology after academician V.I. Kulakov, Moscow, Russia. Click here to read.
The Australian Experience – Itzkowic, D & Cromer, D. Gynecologist, Bondi Junction, NSW Australia – Published the Australiasian Journal of General Practice 2005 (5) 2. Click here to read.
TruScreen – a new ally for cervical cancer screening – Zannardi C, Camerini T, Bucolo C. -Published Ginecorama 2001; 26: 23-4. Click here to read.
Optoelectronic method for detection of cervical intraepithelial neoplasia and cervical cancer – D. Pruski and associates. Karol Marcinkowski University of Medical Sciences, Poland – Published Opto-Electronics Review.,19, no. 4, 2011. Click here to read.
An optoelectronic cervical cancer screening system for screening cervical cancer: comparison with cervical cytology – HE Xiu-kui and associates, Guangdong Provincial Women and Children’s Hospital, Guangzhou China – Published (J South Med Univ, China) 2010; 30(10). Click here to read.
Comparing Study of cervical cancer screening System and liquid-based cytology test in the screening of cervical lesions – Lu Siji and associates, East Hospital, Tongji University, Shanghai- Published Obstet Gynecol, Feb, 2009, Vol.18, No.2 (China). Click here to read.
DISCLOSURE STATEMENT - This device hasn't been approved for Marketing in the US by the FDA. The availability of this and other medical devices in the U.S. require FDA marketing approval. This device counts with CE Mark and is approved for marketing in Europe, Australia, Mexico and other countries in Asia. Market availability in other countries is dependent on the country's regulatory approval process.