Decipher Biosciences, a commercial-stage precision urology oncology company, has filed with the U.S. Securities and Exchange Commission (SEC) to raise up to $100 million in an IPO.
Decipher’s prostate cancer genomic testing products surface information about the underlying biology of a patient’s tumor. The company applies machine learning algorithms to help physicians improve therapy selection and accelerate adoption of new therapies into the urological standard of care. Collectively, the company’s genomic tests have been used by more than 3,200 urologists and radiation oncologists, and at all 28 National Comprehensive Cancer Network centers in the US.
The company’s prostate cancer products are covered by Medicare in nine clinical indications, representing the entire known spectrum of localized, regional and biochemically recurrent prostate cancer. Six clinical indications received Medicare coverage in 2020.
<<One dimension of the company’s capacity to innovate is contained in this non-mean reverting data set>> Decipher’s whole transcriptome analysis of clinical patient samples from its commercial channel and its participation in practice-changing clinical trials is used to build and expand its Decipher GRID database, one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID is the company’s proprietary engine that drives product development for internal development and for its pharmaceutical partners.
Last year, Decipher announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), issued a final local coverage determination (LCD) that expands coverage for Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) to include all men with localized prostate cancer being considered for treatment. Decipher is the first genomic test to receive Medicare coverage across the spectrum of localized disease which addresses an estimated 234,665 men annually with prostate cancer in the U.S. In the initial treatment setting, the LCD provides coverage for men in very low through very high and pelvic lymph node positive NCCN risk groups. Following surgery to remove the prostate, Decipher is covered for all men being considered for treatment, both immediately after surgery, and after disease recurrence.
According to the company, the worldwide prostate cancer therapeutic market is one of the fastest growing cancer therapeutic markets of the decade and grew from approximately $2.0 billion in 2010 to an estimated $10.0 billion in 2019. The increase in the number of available therapeutics has led to challenges in therapy selection for physicians and patients.
Within the urologic cancer space, the most common cancer in men is prostate cancer, with approximately 192,000 new cases per year and over 3.1 million men living with the disease in the U.S. alone. Approximately 92% of new cases of prostate cancer are diagnosed as localized disease and approximately 8% of new cases are diagnosed as metastatic disease. Depending on the diagnosis, prostate cancer therapies include surgery, radiation therapy, hormonal therapy, chemotherapy and other targeted therapies, which all have varying side effect profiles and efficacy based on the unique characteristics of a patient and the stage of his disease. Once a patient is initially diagnosed with localized prostate cancer, in order to determine the appropriate patient management and therapy strategy, patients are stratified by their clinical risk with the goal of predicting the patient’s risk of metastasis and prostate cancer-related mortality.
According to the company, accurate risk stratification remains a critical unmet medical need in the management of prostate cancer, with current risk stratification methods generally being from 60% to 68% accurate in predicting metastasis. This low accuracy has resulted in patients being overtreated or undertreated, which in each case, has led to suboptimal care management strategies and deleterious outcomes for many patients.
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