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BioPorto places focus on flagship NGAL kidney-injury test

The Danish company is seeking FDA approval of the test for use in both adults and children
human kidneys
OVERVIEW: BIOPOR The Big Picture
The test measures NGAL levels, a biomarker that increases in response to injury, as much as 24 hours before it would be detectable
  • The Danish company is aggressively marketing its proprietary NGAL Test, which provides early risk assessment of acute kidney injury (AKI) 

  • NGAL Test has not yet been approved for use in the US; the FDA wants more data

  • Expects FDA clearance of the test for children in the first half of 2019

  • Company continues to build up its US sales team


What the company does

BioPorto A/S  (CPH:BIOPOR) is an in-vitro diagnostic company based in Hellerup, Denmark that provides a range of diagnostic tests and antibodies to treat obesity and diabetes, innate immunity, allergy and infectious diseases to health care professionals in 80 countries. 

The company, which was founded in 2000 and has 28 employees, has been aggressively marketing its proprietary NGAL Test, which provides early risk assessment of acute kidney injury (AKI). BioPorto says its NGAL Test can detect AKI earlier and more reliably than other tests on the market.

AKI is a well-known complication resulting from injury to the kidney, which is common after surgeries such as kidney transplants and heart-bypass surgery.

The NGAL Test helps doctors to tailor a care plan more quickly and effectively than standard testing, which reduces the risk of renal failure and/or death. The test measures NGAL levels, a biomarker which increases in response to injury, as much as 24 hours before it would otherwise be detectable. The company says the standard testing regime can take up 72 hours to detect injury to the kidney.

BioPorto already has an established business selling antibodies globally. The company offers more than 400 monoclonal antibodies, which arer types of lab-created proteins that can bind to substances in the body, including cancer cells. The antibodies are made by identical immune cells that all clones of a unique parent cell. The antibodies are used in research disciplines such as microbiology, immune deficiency, renal, peptide hormones and plasma proteins.

Inflection Points

A challenge facing the company is the fact that the NGAL Test has not yet been approved for use in the US, although BioPorto has been pushing for US Food and Drug Administration clearance. In July 2018, the company applied to the FDA to approve the test for adults based on a study of more than 500 patients. But the FDA requested more data to continue the clearance process. As a result, the company has launched a second study of 150 to 200 patients to gather more data to add to its revised FDA application.

Meanwhile, the company last month named Amy Winslow as president of its US subsidiary as it prepares to make a second try with the FDA. Winslow was president and CEO of Magellan Diagnostics, a point-of-care company in Boston.

CEO Peter Eriksen, in the company’s 2018 annual report, acknowledged the FDA setback but said the company was lobbying hard both the US medical industry and politicians for approval. He also noted the company last year saw an 80% increase in Research Use Only sales of the NGAL test in the US.

"This is the first step in BioPorto’s strategy of expanding the product portfolio vertically to penetrate and capitalize on a massive global market opportunity for the proprietary and leading NGAL technology," the company noted in the report. 

BioPorto has entered into agreements with Roche Diagnostics and Siemens Healthcare to help with the distribution of NGAL Test following FDA clearance.

In addition, the EU last year granted BioPorto a patent covering the monitoring of the onset of a renal disorder by NGAL. The NGAL Test is available for diagnostic use in Europe. 

Outlook

BioPorto plans to submit two regulatory clearance applications for the NGAL 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. Winslow’s efforts will be key as the company builds out its US sales team.

“As we prepare for FDA clearance for The NGAL test, it is critical to establish a strong presence in the US to deliver rapid growth. Amy will lead the charge,” said Eriksen.

The company hopes to see some rapid growth in 2019 and beyond. BioPorto reported slightly higher revenue for 2018 versus the prior year. For 2019, the company expects the FDA to approve the NGAL test for children.

Contact the author: [email protected]

Follow him on Twitter @PatrickMGraham

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