BioPorto A/S (CPH:BIOPOR) named Amy Winslow president of its US subsidiary, BioPorto Diagnostics Inc, as it prepares FDA applications for a new kidney diagnostic test, the Denmark company announced Monday.
Before joining BioPorto, which provides diagnostic tests and antibodies to health care professionals, Winslow was president and CEO of Magellan Diagnostics, a point-of-care company based in Boston. She increased its profitability and ultimately led a sale of the company.
Prior to that, she served as VP of marketing at Athena Diagnostics, a neurodiagnostic medical laboratory.
“I am pleased to welcome Amy to BioPorto’s leadership team,” CEO Peter Eriksen said. “As we prepare for FDA clearance of The NGAL Test, it is critical to establish a strong presence in the US to deliver rapid growth. Amy will lead this charge.”
The NGAL Test is designed to detect acute kidney injury by measuring NAGL levels, a biomarker which increases in response injury, as much as 24 hours before it would otherwise be detectable.
BioPorto expects to submit two regulatory clearance applications for the test to the FDA in 2019, one in the first half of the year for clinical use in children under 21 and one in the second half of the year for use in adults.
The Copenhagen-listed stock closed up 1.4% to 3.92 krones.
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