BioPorto (NASDAQ COPENHAG:BIOPOR) A/S has announced that the strong performance of its flagship NGAL test drove revenue growth for the group in the first quarter of this year as it reiterated its guidance for full-year revenue.
The Denmark-listed in vitro diagnostics company reported revenue of 6.5 million Danish kroner in the first quarter of 2022, a 17% increase over the previous year.
The revenue growth reflected a 70% increase in sales of the NGAL test, primarily from research use only (RUO) sales in the US and the timing of customer orders, which were up 116% over the prior year. Rest-of-the-world (ROW) sales of the test increased by 10%.
The company maintained its guidance for revenue of 24-26 million kroner for the financial year 2022.
READ: BioPorto reports 2021 revenue increased year-over-year; eyes FDA submission for its flagship NGAL Test
The NGAL test helps physicians identify patients at risk of Acute Kidney Injury (AKI) more rapidly than with current standard of care (SoC) measurements, enabling earlier intervention and more tailored patient management strategies.
The test has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for expedited review.
“The first quarter of 2022 was an encouraging start for BioPorto (NASDAQ COPENHAG:BIOPOR) and this new team on several fronts,” BioPorto (NASDAQ COPENHAG:BIOPOR) CEO Tony Pare said in a statement. “We have developed and are executing detailed plans to support US FDA submission, approval, and launch of the NGAL Test. We also achieved favorable revenue growth, including NGAL Test sales, reflecting a combination of growing clinician interest in this impactful biomarker for critical care patients and the timing of customer orders.”
BioPorto said its “clear priority and focus” is on obtaining US FDA approval of the NGAL Test for use in pediatrics (under age 22) and drive its adoption in the US.
The company is enrolling pediatric patients at 15 top hospitals across the US for the third part of a three-part clinical study to support an FDA submission of the NGAL Test for use in identifying children under age 22 at risk of AKI.
It continues to expect that it will complete the targeted enrollment for the study's objectives in the second quarter of 2022, and then finalize analysis of the data to support the FDA filing.
BioPorto recently raised 93.1 million kroner from a rights issue, which will be used to fund the submission of the NGAL Test application for pediatric use in the US, prepare for a commercial launch and implement programs to drive market adoption.
Contact the author at jon.hopkins@proactiveinvestors.com