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BioPorto places focus on flagship NGAL kidney-injury test

Snapshot

The Danish company is seeking FDA approval of the test for use in children and eventually adults

human kidneys

Quick facts: BioPorto

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NASDAQ OMX:BIOPOR
Market: NASDAQ OMX
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  • Company has developed a proprietary NGAL Test, which provides early risk assessment of acute kidney injury 
  • The NGAL Test is available for diagnostic use in Europe but has not yet been approved for use in the US
  • Raised US$5.5 million in financing as it builds up US sales team

What BioPorto 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 an 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 to 72 hours to detect injury to the kidney.

Aside from the test, BioPorto has an established business selling antibodies globally. The company offers more than 400 monoclonal antibodies, which are 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 are 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.

How is it doing:

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 for use in children. The company is currently conducting studies for use in adults.  

Following discussion with the FDA, BioPorto in November announced that it will supplement its pediatric 510(k) application with additional data in order to fully respond to the most recent review shared by the agency.

The valuable study from which BioPorto drew its original dataset demonstrated that the NGAL biomarker can be successfully deployed to assess risk of pediatric AKI. But the FDA disagreed with the clinical community, expressing concern over a risk of clinician bias in the data.

BioPorto, which recently raised US$5.5 million in financing, will provide a follow-on dataset designed to demonstrate NGAL’s utility not only to clinicians but also to the FDA. The company expects to submit a revised application in the second quarter of 2020.

“The FDA saw some risk of bias in the data from the AWARE study, which we used in our application, which we must address. While this is, of course, disappointing in the short term, I believe the dialogue and feedback from FDA, along with the additional data we will collect, will strengthen our future commercial position and augment our ongoing adult studies,” said BioPorto CEO Peter Eriksen.

As a result of the company’s decision to provide additional information to the FDA, BioPorto has changed its financial guidance for full-year 2019 to about US$4.3 million in revenue from US$4.7 million. 

The company, however, reported that third-quarter revenue increased 24% year-over-year to US$980,000 -- stemming in part from demand for the NGAL test for research use and bulk orders for its antibodies for pharmaceutical research and in-vitro diagnostic testing.

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

The EU also has 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. 

Inflection points:

  • Leverage strategic investments to establish the clinical need for NGAL as a biomarker for AKI risk assessment
  • Supply data to FDA to support clearance of the NGAL test in adults  
  • Review new opportunities for NGAL and company's antibody library
  • Build RUO sales and awareness of AKI and NGAL in the US ahead of launch 
  • Build US organization by onboarding leadership and hiring core commercial team 
  • Prepare for US launch of NGAL Test through direct sales and partnership

What the CEO says: 

"It is important to say that if we are looking at the test we are providing, it is going to be a ground-breaking, paradigm shift, and therefore, of course, the FDA has some questions," BioPorto CEO Peter Eriksen told Proactive in an interview. 

 

 

 

 

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Watch

Full interview: BioPorto reveals 'healthy growth' in second quarter revenue

BioPorto A/S (CPH:BIOPOR) CFO Ole Larsen tells Proactive the diagnostic company saw "healthy growth" in revenue for the second quarter, where revenue grew by 10% to DKK (Danish Krone) 7.8 million (US$1.16 million) compared to DKK 7.2 million (US$1.08 million) in the same period in the previous...

on 08/15/2019

4 min read