A recent news report produced by Fox News pertaining to the connection of HPV and Oral Cancer, is triggering awareness across the United States about the importance of HPV/Oral Cancer screenings. According to the Oral Cancer Foundation, 40,000 people residing in America will be diagnosed with oral cancer this year alone, with a compelling 80% of those cases being directly linked to a strand of HPV, known as HPV-16. The Human Papillomavirus is well known for being the culprit in causing a variety of cancers such as cervical and genital cancers (vulva, penis, oropharynx and anus) as well as Respiratory Papillomatosis. In most cases, symptoms are absent and most live unaware that they have contracted a potentially life threatening, cancer initiating virus.
To date, the only widely available screening technique for HPV in women is the Papanicolaou test (also referred to as a Pap smear). This invasive, yet accurate technique comes at the cost of discomfort at the doctor-patient level, due to the fact that the test is conducted by physically collecting cells from the opening of the cervix and endocervix which are then sent to lab for analysis of abnormalities. Though the test is definitive, many women are hesitant and unable to complete the screening due to a number of factors which include but are not limited to humility, religious restrictions, inaccessible resources, and shame. With the evolution of modern science and medicine, most types of cancers caused by HPV are treatable but early detection is the deciding factor in survival. With the number of HPV related cancers cases dramatically ascending, there is an urgent need for a screening procedure that contours to the comforts of women and broadens the availability of screening to men.
Trovagene (NASDAQ:TROV) is a molecular diagnostics company primarily focused on developing urine-based nucleic acid tests for patient screening. A patent protected proprietary HPV assay has been developed that amplifies the E1 genomic region and identifies all high-risk subtypes of HPV in one reaction. The implications of urine-based testing technology entail the opportunity for users to accurately take the sample from the comfort of their own home, which could potentially grant women the opportunity to bypass the Pap smear completely and everything that comes along with it. Earlier this month on February 12, 2013, a press release was issued stating:
The Company expects to achieve analytical and clinical validation of the [urine-based HPV] test in its CLIA laboratory in March 2013. When validation is completed, the test will be available to clinicians and their patients. In addition to the ongoing HPV validation studies, one clinical trial has been completed in India and two additional trials are underway in collaboration with the Barretos Cancer Center, Brazil and Strand Life Sciences, India.
With the release of this news approaching near on the horizon, the recent pullback from the 52-week high of $8.96 and recent bearish market sentiment could signal investors to buy into the opportunity that presents itself here. ROTH Capital's has initiated Trovagene with a buy and price target of $11; AEGIS Capital has valued the company at $12. Trovagene is concurrently developing a pipeline of patented diagnostics testing which will also be progressing and updated in 2013:
The oft-misunderstood potential upside that lies within Trovagene, is their patented analysis of transrenal nucleic acids (TrNAs) in urine. Other players in the molecular diagnostic space have been limited to technology using blood samples such as Sequenom, Inc (NASDAQ:SQNM), a company developing molecular diagnostics for prenatal and retinal care diagnostics. An excerpt from Trovagene's website, outlines the limitations in question when comparing blood and urine sampling:
- The kidney acts as a filter, passing TrNA from complex, multicellular, multicomponent blood into urine, a far simpler aqueous environment.
- The collection procedure is non-invasive and does not require the involvement of trained medical staff.
- Urine as a sample type supports repeated testing when required and poses no discomfort for the patient.
- Trovagene technology utilizes existing analytical equipment platforms, minimizing the requirement for new capital equipment expenditures.
- TrNAs are stable at room temperature for extended periods with the addition of a simple preservative. Nucleic acids in blood and many other traditional samples are not.
- Sample processing and tests can often be easily automated.
- Isolation of TrNA markers from large volumes increases the sensitivity of the tests. This cannot be done as easily using blood or tissue specimens, which have inherent volume limitations.
- Blood or sputum samples for detection of infectious diseases cannot be easily obtained from many patients, including small children and the elderly. Urine specimens typically present minimal acquisition concerns.
- Blood and other bodily fluids are highly infectious by nature, urine is not.
- Blood and other bodily fluids are legally considered biohazardous. Urine is not.
Over the course of the 2013, a diverse selection of pipeline developments will be maturing which could potentially push the price of owning Trovagene's equity up as these near-term catalysts approach. Ever growing cancer awareness, specifically cancers with origins stemming from HPV, presents opportunity in the short-term as people are becoming more conscious of dangers and cost of not being tested. Patented transrenal nucleic acid analysis can potentially offer a monopoly in molecular diagnostics as patients' transition from blood to urine sampling.