Early Detection, Better Outcomes
Guided Therapeutics, Inc. has developed a platform technology for the early detection of disease that leads to cancer. Based on our patented biophotonic technology, the products use light to detect disease at the cellular level and provide painless and immediate results at the time of the examination.
Testing for cancer today usually involves a taking a tissue sample, like a biopsy, and sending it out to a specialist at a laboratory for results. Patients worry while waiting on test results and in many instances are given the wrong diagnosis – in most cases a false-positive result. A false positive diagnosis means the patient will undergo more testing only to discover later that they are healthy.
Our technology non-invasively scans the suspicious tissue with cool white light providing results, that studies have shown, can detect pre-cancer up to two years earlier than the tissue-sample method and with fewer false-positive results. This means less pain, no time waiting for results and fewer unnecessary treatments.
LuViva® Advanced Cervical Scan
Our first non-invasive cancer detection product is the LuViva® Advanced Cervical Scan. LuViva is in use in Canada, Latin America, Europe, Asia and Africa and is under premarket application (PMA) review by the U.S. Food and Drug Administration.
LuViva is designed to determine the true likelihood of treatable cervical disease that may lead to cancer in women aged 16 years and over who have been screened for cervical cancer and have an abnormal result. About 80% or more women with an abnormal result at this point in the testing process will eventually be diagnosed as having a false positive result – but after having an unnecessary colposcopy and biopsy. A one-minute scan with LuViva can rule out about 40% of the false-positive cases immediately without the need for colposcopy and biopsy. LuViva has also been shown in clinical trials to identify disease up to two years earlier than colposcopy and biopsy.
LuViva has also shown promise as a potential screening tool in the developing world to be used where the Pap test or HPV test are not widely available. A clinical trial is underway to expand LuViva’s capabilities as a non-invasive cervical cancer screening product.
Cervical Cancer is a Big, Global Problem
After breast cancer, cervical cancer is the second most common cancer affecting women’s health. It is a leading cause of cancer deaths in the developing world for women of childbearing age.
Incidence of Cervical Cancer Worldwide:
- 528,000 cases of invasive cancer (2012)
- 266,000 deaths (2012)
In the U.S.:
- 500,000 cases of precancer
- 12,360 cases of cancer annually (2014)
- 4,020 women will die from cervical cancer (2014)
- 55-60 million Pap tests annually
- 5.5-6 million follow-up referrals
Screening and diagnosis are effective but costly in developed regions of the world. Common screening methods that lead to additional testing are positive for human papillomavirus (HPV) or an abnormal Pap test (cytology).
In developing regions, where screening methods are less commonly available, there is a different story.
“In sub-Saharan Africa, 34.8 new cases of cervical cancer are diagnosed per 100 000 women annually, and 22.5 per 100 000 women die from the disease. These figures compare with 6.6 and 2.5 per 100 000 women, respectively, in North America. The drastic differences can be explained by lack of access to effective screening and to services that facilitate early detection and treatment,” World Health Organization report.
Improving Cervical Cancer Detection with LuViva
Testing for cervical cancer today in the developed world involves taking a tissue sample – like a Pap test (cytology) for screening or a biopsy for diagnosis and sending the samples to a laboratory where they are read by a medical specialist. Results can take several days or weeks, delaying treatment and creating a time of uncertainty for the patient and her family.
In the developing world it’s a different story. Screening programs may be limited to a portion of the population in the larger cities with almost no screening is the rural areas.
LuViva can improve care in both situations.
In the Developed World:
Up to 80% or more of colposcopies and biopsies for for women who have abnormal Pap tests are found later to be normal or not necessary. If HPV is used for screening those rates could go up.
Unmet Clinical Need for LuViva: A non-invasive “triage” product to determine which patients that screen positive with Pap/HPV need a biopsy (true positives) and which don’t (normal or false positive).
In the Developing World:
Cervical cancer remains a leading cause of cancer death for women of childbearing age due to the lack of laboratory infrastructure.
Unmet Clinical Need for LuViva: A non-invasive “screening” product that provides an immediate result in countries with little Pap/HPV screening.
The platform technology that is LuViva can be applied to other forms or carcinoma. We’ve conducted human testing with the technology on patients at risk for esophageal cancer with promising results. While a great deal more testing and development work needs to be done on that product, we believe that there is a need for our technology in the esophageal market.
Other cancers, in addition to cervical and esophageal, where the technology can be applied:
- Head and Neck Cancer
- Anal Cancer
- Colorectal Cancer
- Skin Cancer
Our Business Model
Our business model is based on sales of a device, in this case the LuViva® Advanced Cervical Scan and a single-use, disposable patient interface called the Cervical Guide. The continuing revenue from the Cervical Guides provides value for our shareholders. The Cervical Guide provides calibration of the LuViva before each test and assures the patient of a cross-contamination free examination.
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use.