Arphion is dedicated to bringing breakthrough oral healthcare non-invasive diagnostics and treatments to market. Products are currently under development for the diagnosis of both benign and malignant diseases such as Oral Lichen Planus and Oral Squamous Cell Carcinoma. We seek to significantly improve patient health by increasing cure rates and reducing needless patient pain and discomfort.
There are over 600 different diseases that occur in the oral cavity. The current gold standard for the detection of oral diseases - from benign lesions to oral cancers - is visual inspection followed by surgical biopsy. Each year in the U.S. about one million surgical oral biopsies are performed. These are generally performed to distinguish the 43,000 new cases of oral cancer each year in the US from benign lesions.
There are several disadvantages to this method, however. Because of the cost, pain, and invasiveness of the biopsy method, clinicians are reluctant to have tested lesions that are likely to be benign. In addition, a trained healthcare provider identifies lesions that may be malignant by visual inspection, but error can occur from variable levels of expertise. Furthermore, patients are often reluctant to comply with the recommendation to have the lesion surgically biopsied by an oral surgeon and lack of follow-up interaction leads to delays in treatment. Because of these delays in evaluation and treatment painful benign lesions go untreated and cancer progresses from a highly treatable stage one which leads to only 50% of patients surviving past five years. The problem is late detection of this cancer leads to less effective treatment.
Thus, there is a clear need for new methods that make detection easier and they must be non-invasive. In the United States and in much of South East Asia, where the disease is the 3rd most common cause of cancer death, this non-painful approach would be a great benefit.
For benign diseases such as OLP there are no other competitive tests other than surgical biopsy and so therefore most OLP is undiagnosed or left alone. For OSCC the only other advanced competitive product to the Arphion test is OralCDX™. Like the Arphion test, OralCDX utilizes a noninvasive cytology brush to collect cells. Unlike the Arphion test, visual inspection of cells by a trained clinician unfortunately leads to misses in the earliest stages of cancer; in addition, a lack of ability to dissociate between non-cancer and cancer, increases error because of an over-reliance upon cell structure and shape changes compared to our molecular genetics. Flaws in its usefulness have recently prompted the ADA to remove its approval of the OralCDX test. Other fluorescent, and spectroscopic analyses may in the future be complementary to the Arphion non-invasive biopsy approach, but they are lack demonstrated accuracy, ease of use, and repeated ability to provide continual clinical assessment.
Arphion’s strategy is to file its tests as a Laboratory Developed Test (LDT) through a CLIA-certified laboratory. This will allow the company to begin marketing the product without having to submit to the FDA for approval or clearance. We would then ultimately look for additional regulatory support through a 510(k) application using FDA based equivalence to tests such as the OralCDX™ test. These avenues to market will allow risk assessment of oral lesions, and let us begin marketing product sooner since it is less expensive and simpler than other FDA approval pathways.
Arphion will sell diagnostic kits and provide clinical evaluation of the samples - either through a CLIA-certified laboratory partner or directly as it expands. We intend to market kit use to a variety of oral healthcare providers. Because of the sensitivity of the Arphion test it will not only be useful for the initial detection of the disease, but permit diagnosis of non-cancer with additional opportunity for post-treatment follow-up to monitor treatment successes. Our unique package of features for this test: non-invasive, painless sample acquisition and repeat identification diagnostics at an identical site can make Arphion an important provider of early diagnosis for oral disorders.
Based on a potential to capture ~ 20% of the current biopsy market, Arphion believes it can reach revenues of over $50MM in seven years. The Company will seek an exit for its technology through acquisition - most likely by a provider of diagnostics kits to the healthcare industry.