RE: Shore Cap Research Note 17 Jan17 Jan 2024 08:46
All eyes on PSE – off to a strong start in the USA: It is difficult to temper enthusiasm for the PSE test given the size of the market opportunity and the clear need for an improvement over the much-maligned PSA test. Indeed, the numbers are significant with approximately 47m men in the relevant 50-80 age range in the key US market. There are a staggering 25m PSA tests conducted per year in the US and a further 10m men in the UK, despite no formal screening programmes. Given that only about 25% of patients with a positive PSA test who then have a highly invasive biopsy or expensive MRI test, are eventually confirmed as having prostate cancer, there is a clear need for a rapid test which increases the accuracy and predictive value of testing in at risk individuals. Based on the results as part of the PROSTAGRAM study and published in the peer reviewed journal Cancers PSE has the potential to be a best-in-class approach. Encouragingly, the PSE test received an earlier than expected unique reimbursement code in October which likely reflects recognition by payor groups of the clinical importance of PSE as well as its potential to reduce costs. Raising awareness in the US has involved online activities targeting men, their families and physicians of the attributes of “the 94% test”. These are still very early days in the US but leading indicators are positive with 144 tests processed with reimbursement available and invoiced under the unique CPT code from 1st January 2024. During 2024 the plan is to target large organisation accounts to drive adoption and to partner to facilitate more widespread access.
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