Gentian Diagnostics

Haltopen · august 3, 2022, 8:22pm

Denne har gått meg hus forbi.

I dette prosjektet vil partnerne utvikle ny type patentert metode for å bestemme hematokritnivået til små fullblodsprøver (f.eks. en fingerstikk) innen få sekunder etter påføring av prøven. Hematokritnivået er sentralt, ettersom det er direkte relatert til plasmavolumet i prøven, som må være kjent for å ikke indusere ytterligere feil i kvantifisering av biomarkørens konsentrasjon i plasma.

Kan den ses i sammenheng med denne?

Do2Do · august 4, 2022, 10:07am

Ser vi at et mer positivt sentiment for biotech/medtech også løfter Gentian?
Og/eller kan de for en gangs skyld overaske positivt ved Q-pres (om 3 uker)?

TekBot · august 18, 2022, 10:42am

Invitation to presentation of second quarter results

TekBot · august 23, 2022, 11:06am

Gentian Diagnostics signs distribution agreement for Cystatin C

Moss, 23 August 2022

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of innovative and efficient diagnostics, has entered into a distribution agreement for the Gentian Cystatin C Immunoassay with a global diagnostics company. The cooperation is positioned towards the diagnosis and treatment of renal disease, with launch scheduled for the second half of 2022, initially in the USA and Canada.
…

Vis børsmeldingen

“We are pleased to experience increasing demand for Cystatin C as a superior marker for diagnosis and treatment of renal disease, particularly in the US market,” says CEO Hilja Ibert from Gentian Diagnostics.

Gentian’s commercial strategy is to secure broad roll-out and acceptance of its products, which requires distribution through global diagnostics companies.

“This distribution agreement for Cystatin C confirms the attractive clinical benefits of our product and Gentian’s ability to establish commercial partnerships worldwide, adds Ms. Ibert.

Gentian’s new distributor develops and distributes in vitro diagnostic systems mainly destined for biological analysis in medical laboratories on a worldwide basis. These automated analysers meet the needs of various users including private laboratories, clinics and university hospitals.

While the clinical use of Cystatin C can have far-reaching benefits across all patient groups, certain vulnerable patient populations may experience a greater benefit. Some specific patient groups would receive more accurate results with Cystatin C because its concentrations are independent of muscle mass and show less age and gender-related variation relative to creatinine.

Previously, Gentian has outlined the roadmap for its portfolio of high-impact diagnostics tests which supports the company’s revenue growth ambitions. The company expects Cystatin C to remain a key value driver in the realisation of this growth roadmap and confirming clinical relevance and entering global commercial partnerships are key enablers.

For further information, please contact:
Hilja Ibert, CEO
hilja.ibert@gentian.no
+47 919 05 242 (mobile)

Njaal Kind, CFO and COO
njaal.kind@gentian.no
+47 919 06 525 (mobile)

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.

Kilde

Haltopen · august 23, 2022, 11:50am

Dette er nå tredje distribusjonsavtale for Cystatin C. Er det denne markøren som skal dra lasset og inntjeningen over i positivt terreng på kort sikt?

Langvarig avtale med Beckman Coulter
Direktesalg til kunder i USA
20.04.2022: Gentian Diagnostics signs distribution agreement with leading global diagnostics company for Cystatin C
23.08.2022: entered into a distribution agreement for the Gentian Cystatin C Immunoassay with a global diagnostics company.

Sander57 · august 23, 2022, 12:06pm

Ser nødvendigvis ikke slik ut i markedet, kursen beveger seg sidelengs.

Haltopen · august 23, 2022, 12:08pm

Det er nok show me the money som gjelder. Torsdag vil vise retningen videre.

Sander57 · august 23, 2022, 1:45pm

Kommer Q2 da?

Haltopen · august 25, 2022, 6:47am

TekBot · august 25, 2022, 2:28pm

Mandatory notification of trade

Haltopen · august 26, 2022, 6:58am

TekBot · august 29, 2022, 1:59pm

Mandatory notification of trade

TekBot · september 7, 2022, 6:06am

Gentian Diagnostics presents at the Pareto Healthcare Conference

TekBot · september 27, 2022, 6:31am

Gentian Diagnostics presents at Redeye Diagnostics conference

TekBot · september 28, 2022, 9:02am

Gentian Diagnostics obtains IVDR certification

Moss, 28 September 2022

Gentian Diagnosis ASA, a fast-growing developer and manufacturer of innovative and efficient diagnostics for better treatment decisions, is pleased to announce that the first products have been certified by TüV SÜD as complying with the European In-Vitro Diagnostic Regulation (IVDR), EU 2017/746. This certification granted by notified bodies such as TüV SÜD is required for in-vitro diagnostics products to continue being sold in the European Union. The extensive requirements of IVDR were adopted by the European Parliament in 2017 with gradual implementation from 26 May 2022.
…

Vis børsmeldingen

Gentian has implemented the EU regulatory requirements in its systems and processes to ensure continuous compliance and made all necessary preparations to have the first products certified.

Commenting on the achievement, Anne-Mette Akre, VP Quality Assurance and Regulatory Affairs of Gentian Diagnostics says: “This is a very important milestone for us and an extraordinary team achievement to receive this IVDR certification. Since we have a commitment to deliver products of the highest standard and meet our customer needs, we are very proud to have received this certificate for our first products”.

The risk classification of products and involvement of a notified body in the regulatory procedures have been one of the major changes with the implementation of the IVDR. Under the 98/79/EC Directive, 80% of the products were classified as self-declared and the majority of these products will end up in a higher risk class under IVDR. This new regulation calls for additional performance assessments based on scientific, clinical and analytical data. It also improves traceability in the supply chain and establishes a proactive monitoring system for the early detection of issues in products already in circulation. Although the introduction of IVDR is a considerable regulatory burden for the industry, it aims to increase the protection of health for patients and users.

For further information, please contact:
Hilja Ibert, CEO
hilja.ibert@gentian.no
+47 919 05 242 (mobile)

Njaal Kind, CFO and COO
njaal.kind@gentian.no
+47 919 06 525 (mobile)

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.

Kilde

TekBot · oktober 21, 2022, 8:42am

Invitation to presentation of third quarter results

TekBot · oktober 27, 2022, 6:17am

Third quarter 2022 report

(Corrected heading)

Moss, 27 October 2022
…

Vis børsmeldingen

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic tests, today announced its results for the third quarter of 2022.

Highlights
• Sales revenue of MNOK 23.1 in 3Q22, an increase of 34% (35% organic growth) vs 3Q21
• Strong growth in the US enabled by recent distribution agreement
• Additional US distribution agreement for Cystatin C announced in August 2022 is expected to support revenue growth from 2023
• IVDR certification achieved, demonstrating Gentian’s commitment to deliver safe and effective products
• Good progress made on NT-proBNP, a working prototype has been developed from the new immunoparticle candidate
• GCAL® is well received in the market and Siemens collaboration is developing positively

”The Gentian team delivered on several important milestones in the third quarter. Importantly, we achieved IVDR approval, while good progress was made for our two potential blockbuster products GCAL and NT-proBNP. For GCAL, we see broadening market interest in the product and sales are ticking up. This is a result of clinical studies proving the products’ value proposition, endorsements from key opinion leaders and successful marketing and sales efforts together with our commercial partners. Our established products continue to win market share, resulting in strong revenue growth. The common demand driver is a growing and aging population which increases the need for diagnostic tests in combination with a need for increased diagnostic efficiency which is a key advantage for Gentian’s immonuassays,” commented Hilja Ibert, CEO of Gentian Diagnostics.

NT-proBNP, the cardiac marker currently in product development, progressed positively. Initial results with the lead candidate proved to be reproducible, and as a result a working prototype has been established. Further, the establishment of the reference method at the first trial site has been accomplished as planned.

Additionally, one pipeline project was moved from the exploration phase to proof-of-concept, while the other project in proof-of-concept progressed well.

“Going forward, we will continue to mature our pipeline projects while expanding the market for the products already launched in line with our strategy for long-term growth, “adds Ibert.

Webcast
Gentian’s CEO Hilja Ibert and CFO Njaal Kind will present the results today at 10.00 am, followed by a Q&A session. Join the webcast and submit questions via the following link:

https://attendee.gotowebinar.com/register/3718726872559445004

The webcast will be made available on the company’s IR website after the presentation.

IR contact:

Njaal Kind, CFO and COO
njaal.kind@gentian.no
+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 27 October 2022 at 08:00 CET.

About Gentian
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.

Kilde

Do2Do · oktober 27, 2022, 6:38am

Ser jo tilforlatelig ut

Highlights
• Sales revenue of MNOK 23.1 in 3Q22, an increase of 34% (35% organic growth) vs 3Q21
• Strong growth in the US enabled by recent distribution agreement
• Additional US distribution agreement for Cystatin C announced in August 2022 is expected to support revenue growth from 2023
• IVDR certification achieved, demonstrating Gentian’s commitment to deliver safe and effective products
• Good progress made on NT-proBNP, a working prototype has been developed from the new immunoparticle candidate
• GCAL® is well received in the market and Siemens collaboration is developing positively

Men når man ser omsetningen i kvartalene mellom Q3-21 og Q3-22 blir man mindre begeistret. Det er vel enkelt og greit nok et dårlig levert kvartal av ledelsen. Negativ EBIT -8,7mNOK og kasse nå på 94mNOK.

Haltopen · oktober 27, 2022, 7:01am

Altså, veksten er jo der. Sammenligner man med Q321 presentasjonen ser det slik ut:

Men, og det har vært ankepunktet en stund, veksten er og har vært for lav. Man kan lure på når det i det hele tatt skal løsne.

Det positive er at USA endelig er on track og stiger markant. Her har man i en årrekke slitt med salg og det kan endelig se tegn til at det kan løsne der.

GCAL fremdeles ikke med i product split, noe som tyder på at salgstallene er lave (men økende).

fCAL tilbake med sterkere salgstall.

Summa sumarum? Meh… men får gi det noen kvartal til. Har fremdeles noen aksjer her, og øker ikke før en ser større tegn til at det kan løsne skikkelig.

TekBot · oktober 27, 2022, 7:21am

Gentian Diagnostics signs distribution agreement with a major diagnostic company for the GCAL® Calprotectin Immunoassay

Moss, 27 October 2022
Gentian Diagnostics ASA, a fast-growing developer and manufacturer of innovative diagnostic solutions for improved clinical decision making, has entered into a global distribution agreement for its GCAL® Calprotectin Immunoassay with a major diagnostic company.

…

Vis børsmeldingen

“This is the second distribution agreement for GCAL® announced this year, which confirms the products’ value proposition and market potential. The agreement is a result of our market development efforts, and the fact that we’re gaining commercial traction with several of the world’s leading diagnostics companies supports our long-term growth ambition,” says Gentian Diagnostics CEO Hilja Ibert.

The cooperation is positioned towards the market for detection and assessment of inflammatory diseases and infections, with launch scheduled for the first half of 2023, initially in Europe. Depending on regulatory clearance this product will be available in additional countries and regions at a later stage.

Gentian’s commercial strategy is to secure broad roll-out and acceptance of its products, which requires distribution and awareness through leading global diagnostics companies.

The Gentian GCAL® Calprotectin Immunoassay is available in the market for quantitative measurements of calprotectin in plasma and serum samples and based on published scientific findings it is expected to become a key clinical value driver.

According to the stock exchange release dated 28 September 2022, Gentian obtained the European In-Vitro Diagnostic Regulation (IVDR) certification for its first products and the Gentian GCAL® Calprotectin Immunoassay is among these certified products.

For further information, please contact:
Hilja Ibert, CEO
hilja.ibert@gentian.no
+47 919 05 242

Njaal Kind, CFO and COO
njaal.kind@gentian.no
+47 919 06 525

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 protect life. Gentian is based in Moss, Norway, serving the global and veterinary diagnostics markets through sales and representative offices in Sweden, USA and China. For more information, please visit www.gentian.com.

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 Security Trading Act. This stock exchange announcement was published by Njaal Kind, CFO & COO at Gentian Diagnostics ASA, on 27 October 2022 at 09:20 CET.

Kilde