Gentian expands presence in the US market

18. Oct 2019 | 3 min read

Gentian expands presence in the US market

Gentian USA, Inc. collaborates with BioHealth Innovation

Gentian’s subsidiary in the US, Gentian USA, Inc. collaborates with BioHealth Innovation (BHI) in order to expand Gentian’s presence in the USA.

BHI, with its established healthcare market and business expertise, addresses Gentian’s needs at this early market entry stage. BHI’s market analysis expertise will allow Gentian to gain valuable market insight to market both their existing products and their pipeline product developments to the US market. In addition, it will also support launches of newly developed, innovative products.

BHI also provides a landing space for Gentian's first full time US employee.

Market growth

The US IVD market continues to grow steadily, and the collaboration with BHI allows Gentian to support current and new US customers and OEM partners more closely. Importantly, it will also make Gentian products more visible to a larger US customer base.

Dr. Hilja Ibert, CEO of Gentian Diagnostics AS says, “I am impressed with the expertise of the BioHealth Innovation team. They provide perfectly well the capabilities needed for a successful development of our US entity, both scientifically and commercially.

 

Gentian’s current products for the US market

Gentian USA Inc. was established in 2012. The subsidiary has grown it’s market share for the immunoassays Cystatin C and Canine CRP through routine clients and OEM partners.

 

Gentian Cystatin C Immunoassay


Gentian’s Cystatin C Immunoassay (ERM-DA471/IFCC standardised) is CE-marked and FDA 510(k) cleared.

The product is a particle-enhanced turbidimetric immunoassay (PETIA) for use on a wide range of clinical chemistry analysers. The Gentian Cystatin C Immunoassay is an in-vitro diagnostic test for quantitative determination of cystatin C in human serum and plasma. The measurement of cystatin C is used in the diagnosis and treatment of renal diseases.

The immunoassay was first FDA 510(k) cleared in 2007 and Gentian has established several routine customers in the US for this product as well as global OEM partners headquartered in the US.

Gentian Canine CRP immunoassay


The Gentian Canine CRP Immunoassay was launched in 2012 and is a particle-enhanced turbidimetric immunoassay (PETIA) for in vitro diagnostic measurement of CRP in canine serum and plasma samples. The measurement of canine CRP is used in the diagnosis and treatment of inflammatory diseases in dogs.

Gentian has previously established sales of this product in the US via a distributor and also sells to a global veterinary laboratory chain headquartered in the US.

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