We are developing a revolutionary photonics diagnostic assay called OPTIM (Optical Prediction of Time Interval to Metastasis). OPTIM is based on the new technology and adds independent information that more accurately predicts risk of metastatic recurrence than current methods alone. This will help newly diagnosed cancer patients by identifying those who will benefit from early treatment who otherwise might not be treated early enough to alter the outcome.
Harmonigenic™ Corporation was founded to guide from the lab to the clinic, a University of Rochester discovery that if validated will provide better outcomes for cancer patients including better quality of life and lower overall cost by focusing treatment where it is most needed. The discovery was made using a special scanning dual photon microscope modified to measure a parameter which was found to correlate with time to recurrence or metastasis. The parameter was obtained by analyzing the light from a process called second harmonic generation produced while examining the standard pathology slides of breast cancer tissue from initial surgery (Published Article). This discovery is particularly useful in about 60% of women at initial diagnosis who are considered low risk for recurrence (15% recurrence in 10 years in this early initial diagnosis, ER+, node negative patient group). Fear of recurrence unfortunately is independent of prognosis and can drive "over treatment" for the majority of these patients who don't recur even with no further systemic treatment. Due to side effects of endocrine blockers or inhibitors of estrogen, these patients often do not complete treatments prescribed so more accurately identifying people who are more likely to recur provides motivation for those who benefit from treatment, but are not detected as metastatic by current available tests. Further study will test the hypothesis of whether focusing early treatment on those patients more likely to recur, improves outcomes.
Our path to market takes advantage of a unique feature of this technology. We can obtain evidence from published clinical trials by blindly testing archived tissue that was collected at the beginning of the clinical trial and making our prediction, and then quantifying on how well we predicted the already accrued outcomes. Since or photonics assay does not modify the tissue sample through the measurement process we are uniquely positioned to cross reference our performance on the exact same tissue sample which is destroyed but other methods currently on the market. We are dedicated to make this test available at the time of diagnosis so all women with breast cancer can make more informed decisions about treatment by revealing the answers to questions they are asking with more precision based on accurate prediction from this and other parameters that can be combined for the best prediction possible.
While initially discovered using breast cancer tissue we have evidence of possible application to early stage colon cancer and other solid tumors where this discovery, if validated in these other cancers and applied, could produce better outcomes by identifying people who will likely recur even though their cancer was diagnosed early. We want to eliminate the unknown so we can focus on prevention.