BioPorto announced on 3 October 2018 that it had received feedback from the FDA on its outstanding 510(k) application for The NGAL Test for risk use with acute kidney injury (AKI). The agency said that additional data would be required to support a ‘rule-out’ claim (ie that the test can exclude the risk of AKI). The company is engaged in discussions with the agency and has revised its timeline: an FDA decision in mid-2019.
It is difficult to assess the specific area of data deficiency for which the FDA requires more data, but the rule-out claim that was cited is contingent on the negative predictive value (NPV) of the test. This statistic depends upon on both the sensitivity and specificity of the test, as well as the underlying rate of the disorder (AKI). The latter is further complicated by the fact that AKI is defined in terms of serum creatinine, on which NGAL is aiming to improve. Any of these factors could be elements on which the agency requires clarification, albeit not limited to these.
There are number of different paths forward for the company, which depend on the precise data requested. The FDA may want more confidence that the rate of AKI in the study reflects rates more globally (so that the NPV is representative), and this may be addressed using existing historical data, without a new trial. However, we cannot rule out the possibility that more clinical data may be needed. However, we see the FDA keeping the application open as an indication that there are no fatal flaws.
The agency previously approved the product Nephrocheck with the claim that it was ‘intended to be used in conjunction with clinical evaluation’. This is a weaker claim than the rule-out claim being examined, but the agency’s openness indicates a potential pathway in which BioPorto adjusts its claims. We expect more detail following further discussions with the FDA, although the timeline is unclear.
We have reduced our valuation to DKK895m or DKK5.76 per basic share from DKK1,105m or DKK7.10 per basic share. This is driven by a delay in the commercialisation of The NGAL Test. We now expect potential approval in late 2019 with first significant sales in 2020 in the US, and this has similarly pushed back our follow-on indications. Our probability of success remains unchanged as we do not consider that this feedback reflects the ultimate approvability of the product.