Moss, 5 October 2021
Gentian Diagnostics ASA, a fast-growing developer and manufacturer of innovative
and efficient diagnostics for better treatment decisions, is targeting several
large and growing disease areas such as infections and inflammation, kidney
failure and congestive heart failure.
The company today provides an update on project milestones, which includes GCAL
in market development, and SARS-CoV-2 Ab and NT-proBNP in product development.
SARS-CoV-2 Ab is on track for launch in Q4 2021, whereas for GCAL the company is
in final negotiations with the first global partner with an ambition for
commercial roll-out during 1H 2022. The development of NT-proBNP will however be
delayed due to the complexity of the assay optimisation phase.
NT-proBNP: reference method achieved - launch date to be rescheduled
The development of a platform independent NT-proBNP turbidimetric assay is
expected to represent ground-breaking advances in the field of high throughput
diagnostics. Gentian Diagnostics aims to push the boundaries regarding
measurement of low concentrations and a successful development of NT-proBNP will
represent a significant advance for the PETIA technology.
The development of an independent reference method has been achieved and
preliminary results provides for the possibility of calibrating the Gentian
NT-proBNP assay to existing measurement ranges. However, to fully qualify the
reference method, more tests are required, and the company has therefore
initiated further trials to substantiate the method.
The optimisation of the NT-proBNP assay has proven to be more complex than
assumed. Although several milestones have been achieved, it is now apparent that
the technical development will have to continue further before the assay
optimisation phase can be concluded. The remaining challenges are related to
particle aggregation, differences in measurement of NT-proBNP in plasma and
serum samples, and reaching an even lower level of quantification to ensure a
competitive product. The earlier set launch date in Q1 2022 will hence not be
met, and the company will revert with more information regarding a new launch
date once a timeline for the remaining optimisation issues have been
established. The company will host an R&D presentation in connection with the Q3
results scheduled for release on 21 October.
GCAL: in final negotiations with first global partner
The commercial development of GCAL is progressing well. The company advises that
it is in the final stage of negotiating a commercial collaboration contract
regarding GCAL with a leading global diagnostics provider. The goal is to start
the commercial roll-out during 1H 2022. In addition, Gentian has entered into
promising commercial collaboration agreements with specialised distributors in
several countries so far this year, most recently in South Korea.
SARS-CoV-2 Ab: on track for launch in Q4 2021
The SARS-CoV-2 Ab project is in the final development phase. The project is on
track for launch towards the end of Q4 2021, and the company is encouraged by
the increasing interest for antibody testing as a tool to manage immunisation
Other pipeline projects and funding
Gentian advises that other ongoing pipeline development projects are developing
according to plans. Going forward, the company may decide to reallocate
resources to bolster some of the more promising key projects that hold a
commercial potential outside of the existing products. Regardless of such
reallocations, the company's current business plan is fully funded.
Invitation to Q3 2021 and R&D presentation
Gentian will provide more information on its projects as new information becomes
available. On 21 October 10.00-12.00 CET, the company will present its results
for Q3 2021 followed by an R&D presentation. For participation, please register
using the following link:
Njaal Kind, CFO and COO
+47 919 06 525 (mobile)
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Njaal Kind, CFO at Gentian
Diagnostics ASA, on 5 October 2021 at 18:00 CET.
About Gentian Diagnostics
Gentian Diagnostics (OSE: GENT), founded in 2001, develops and manufactures
high-quality, in vitro diagnostic reagents. Gentian's expertise and focus lies
within immunochemistry, specifically infections, inflammations, kidney failures
and congestive heart failures. By converting existing and clinically relevant
biomarkers to the most efficient automated, high-throughput analysers, the
company contributes to saving costs and protecting life. Gentian is based in
Moss, Norway, serving the global human and veterinary diagnostics markets
through sales and representative offices in Sweden, USA and China. For more
information, please visit www.gentian.com.