BioPorto announced that it had submitted an application to the FDA for the paediatric NGAL Test. The application was specifically for the risk assessment of acute kidney injury in children under the age of 21. The application was submitted with breakthrough designation, which we consider very encouraging. The designation shortens the statutory review time to 45 days (from 90) and provides that a portion of data needed be provided after marketing clearance.
The application was made on the basis of a retrospective study of urine samples previously collected to test the NGAL ELISA assay in paediatrics. The company reported a sensitivity of 65.0% and a specificity of 81.8%, with a negative predictive value in this population, which we consider roughly equivalent to previous data reported in adults (albeit not directly comparable).
The breakthrough designation received for this program is important because as part of the evaluation the FDA deemed that the data provides a ‘reasonable expectation that the device could provide for a more effective…diagnosis’ than the standard of care. We consider this an endorsement from the agency, and encouraging regarding its final marketing decision on the product.
Breakthrough designation is additionally important for this product because it provides for initial clearance of a medical device with a lower threshold of clinical data supported by subsequent postmarketing studies. The company is currently seeking clearance for the test using retrospective clinical data, which the agency is typically more reluctant to accept, but with breakthrough designation, there is the potential to fill any gaps with postmarketing studies.
We have increased our valuation to DKK966m or DKK5.83 per share, from DKK952.8m or DKK5.75 per share. This is driven in part by increasing the probability of success for the paediatric NGAL test to 60% from 45%, based on the breakthrough designation, as well as rolling forward our NPVs. This is offset by an increase to administrative costs and lower cash (DKK32.2m).