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A significant asset that CytoDyn acquired in the November 16, 2018 acquisition of ProstaGene is the Prostate Diagnostic Test (PCa Test). This test, developed by a leading oncologist, provides an unbiased and valuable tool for determining outcomes of patients diagnosed with prostate cancer compared to the Gleason score, the current standard for prostate cancer diagnosis. It leverages technology using an artificial intelligence approach based on gene signatures. The PCa Test employs 16 gene biomarker signatures for prognostication and therapeutic substratification of prostate cancer using sophisticated proprietary artificial intelligence algorithms.
Prostate cancer is the most commonly diagnosed cancer in men. About 1 in 9 men will be diagnosed with prostate cancer during his lifetime. It is third only to nonmelanoma skin cancer and lung cancer as the leading cause of cancer death. It is estimated that 1.6 million new cases of prostate cancer and 366,000 prostate cancer deaths are reported annually. The current standard of care for treating prostate cancer is based upon the Gleason score. Patients with prostate cancer with a low Gleason score are observed, while those with higher Gleason scores typically undergo radical prostatectomy. In 2008, the United States Preventive Services Task Force (USPSTF) recommended against screening men aged 75 years and older. In 2013, prostate cancer screening of men in the U.S. decreased by 18%.
Furthermore, management of prostate cancer has increasingly deployed either "watchful waiting" or "active surveillance" to avoid unnecessary surgery (prostatectomy) and radiation and/or chemotherapy with its attendant side effects. Since 2004, there has been a 72% rise in metastatic prostate cancer. In order to more precisely guide therapeutic options for men diagnosed with prostate cancer through histological analysis of the prostate biopsy, additional predictive tools have been developed including gene signature-based tests. Several gene signature-based tests have been developed and are currently reimbursed by U.S. health providers. CytoDyn's Prognostic test compared more than favorably with current tests in the market place.
The PCa Test can provide a "second opinion" and provide valuable guidance to assist the physician and patient to make an educated and informed decision regarding a potentially life-altering surgery. The side effects of radical prostatectomy are not to be underestimated. In addition to the potential risk of bleeding and infection at the time of surgery, it can significantly and permanently alter the quality of life for a man including urinary incontinence and erectile dysfunction. The PCa Test provides unbiased data to assist the physician and prostate cancer patient in making a difficult decision based on their true risk profile.
In a recent retrospective clinical study with a 10 year follow up in two separate groups of patients, the PCa Test was assessed in patients with a Gleason score of 7, considered indeterminate/intermediate, and classified this group as the baseline measure. Consistent with the Gleason scoring system, all the patients in this population had a prostatectomy. Using the Cox Proportional Hazards model, the addition of the PCaTest Score was able to further characterize patients with indeterminate/intermediate Gleason score as low risk or high risk. Patients with high-risk scores identified an elevated risk of recurrence in population 1 (HR=9.44, p=2.4x10-5) and population 2 (HR=3.43, p=7.2x10-3). The results show CytoDyn's prognostic test as providing substantial additional value beyond the current standard of care in determining the outcome and therefore helping doctors and patients to make better decisions about their treatment.
New data on the PCa Test has followed men with prostate cancer for over 10 years and provides substantial additive discriminative value for predicting outcomes of patients diagnosed with prostate cancer. This new study adds important data that is additive to the high predictive value of the PCa Test has shown in past studies compared with currently available genetic tests. The positive clinical data from two groups totaling 218 patients and followed for 10 years adds to three prior clinical studies conducted in more than 350 patients that demonstrated a high predictive value for CytoDyn's PCa Test in determining the outcome of men diagnosed with prostate cancer. The new findings support the Company's strategy for seeking U.S. Food and Drug Administration (FDA) approval for the PCa Test.
The PCa Test is aligned with CytoDyn's vision of improving the quality of life with those affected with potentially life-altering diseases.