Gentian Diagnostics ASA

Regulatory Filings • Mar 22, 2017

GENTIAN ACHIEVES PROOF-OF-CONCEPT ON G-1001 AND PROVIDES A COMPANY UPDATE

GENTIAN ACHIEVES PROOF-OF-CONCEPT ON G-1001 AND PROVIDES A COMPANY UPDATE

Moss, 22 March 2017

Gentian Diagnostics AS (OSE: GENT-ME) is pleased to announce that it

has achieved Proof of Concept on its product candidate, G-1001. G-

1001 is currently Gentian's largest commercial pipeline opportunity,

addressing a market of approximately 150 million tests annually. The

proof-of-concept-phase is the most critical step in Gentian's

development process. In this phase, the technical risk is

substantially reduced, freedom to operate is assessed and patent

applications are submitted. Lastly, the proof-of-concept phase also

includes evaluation of the market potential and points of

differentiation versus competitors.

G-1001 will now enter the optimization phase, which is the next step

in the development process. Finally, the product will go through a

phase of verification and validation. Gentian Diagnostics expects

commercial launch of G-1001 in the first half of 2019.

In addition to G-1001, Gentian Diagnostics has also achieved Proof

of concept on its new, super-sensitive technology platform, the

Nanosense II technology. With Nanosense II, Gentian has established

a new state-of-the-art level of sensitivity on the big, automated

instruments present in all clinical laboratories, and built a basis

for several new and unique product launches in the future. Gentian

Diagnostics targets to launch one new product on average, starting

from the second half of 2017.

COMPANY UPDATE

Reference is made to the stock exchange announcement on 31 January

2017 regarding challenges in the Chinese market. Gentian and its

distributor are still working on finding a solution, but the order

that was put on hold will not be delivered in Q1. Consequently,

Gentian now expects total revenues of MNOK 6.0 - 6.4 for the first

quarter 2017. Further notifications will be provided in respect of

the development in the Chinese market.

As described in stock exchange announcement on 31 January 2017, the

challenge in China will not have any impact on Gentian's pipeline,

and the first new product is expected to be launched in 2017.

Commenting on the news, CEO Bård Sundrehagen:

"Achieving Proof of concept on G-1001 and our Nanosense II

technology platform is the biggest achievement of our R&D-department

in the history of Gentian. I would like to congratulate the team for

this major innovation as we now start initiating the final

development steps before commercialization. The company is in

parallel working to improve its commercial infrastructure to prepare

for one new product launch per year on average starting from the

second half of 2017."

For further information, please contact:

Bård Sundrehagen

CEO, Gentian Diagnostics AS

E-mail: Bard.sundrehagen@gentian.no

Cell Phone: +47 924 14 117

ABOUT GENTIAN DIAGNOSTICS AS

Gentian Diagnostics AS is a medical diagnostics company listed on

Merkur Market, Oslo Stock Exchange with the ticker "GENT-ME".

Gentian is headquartered in Moss, Norway, with a representative

office in China and distribution subsidiaries in Sweden and USA.

Gentian designs, develops and markets in vitro diagnostic reagents

(IVD) based on its proprietary Nanosense technology. The goal is to

offer efficient and accurate reagents for major clinical chemistry

platforms with a focus within the areas of kidney disease, cardiac

disease, inflammation and veterinary medicine. The Nanosense

technology will enable users to move assays from low volume

immunology platforms to fully automated, high throughput instruments

with shorter turnaround times, better workflow and improved cost

efficiency.