Gentian Diagnostics

Haltopen · oktober 27, 2022, 7:28am

Og der kom det et lite tegn på at det kan løsne for GCAL i 2023:

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

Peiles inn på inflammatoriske sykdommer og infeksjoner (!), samtidig er det første gang det nevnes ekspansjon i andre regioner. Er det partner som vil kjøre dette godkjenningsløpet?

TekBot · desember 5, 2022, 10:10am

Patent granted for NT-proBNP in the U.S.

Moss, 5 December 2022

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic tests, is pleased to announce that it has been granted a patent in the U.S. for its product candidate NT-proBNP.
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NT-proBNP is a non-invasive biomarker for the diagnosis of congestive heart failure (CHF). An aging population and lifestyle choices increase the cost burden in healthcare systems and thereby drive demand for NT-proBNP testing.

Gentian’s assay, which is currently under development, aims to be the first turbidimetric IVD test for NT-proBNP supporting improved laboratory throughput and productivity. Additionally, Gentian aims to contribute to easier standardisation of test results.

“The issued patent is an important milestone towards the development of NT-proBNP as it de-risks the product’s commercial potential. We remain optimistic that we can overcome the remaining challenges in product development,” commented Hilja Ibert, CEO of Gentian Diagnostics.

In its Q3 2022 report, Gentian gave an update on the progress made on NT-proBNP currently in the optimisation phase. A working prototype was established in the quarter and additional testing is ongoing. Further, the establishment of the reference method at the first trial site has been accomplished supporting the process of calibrating the immunoassay towards commercially available products.

The patent for NT-proBNP is issued by the U.S. Patent and Trademark Office.

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 lie 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 and veterinary diagnostics markets through sales and representative offices in Sweden, USA and China. For more information, please visit www.gentian.com.

Kilde

TekBot · desember 14, 2022, 2:26pm

Gentian Diagnostics appoints new CSO

Moss, 14 December 2022

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic tests, has appointed Dr Aleksandra Havelka as its new Chief Scientific Officer (CSO). Dr Havelka comes from the role as VP Science and Clinical Affairs at Gentian Diagnostics and was previously Biochemist and Unit Manager at Karolinska University Laboratory with research focusing on biomarkers for inflammation and infection.
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Dr Erling Sundrehagen (71), who co-founded Gentian in 2001 and has held the CSO role since 2019, is moving into a new role as Consulting Founder and will initially devote his time to the development of NT-proBNP. In 2022, Gentian strengthened its R&D team which now consists of Dr Torsten Knüttel (VP R&D), Dr Tom Nilsen (Head of Product Development) and Dr Ingo Curdt (Head of Innovation and Research) who joined the company earlier this year.

In connection with the organizational changes, Dr Sundrehagen says: ” We now have a highly qualified technical team with best-in-class development capabilities and a track record of bringing industry-changing innovations to the market. I am confident that Gentian will continue to bring innovative diagnostics products to the market going forward.”

“We are delighted that Aleksandra Havelka, a highly qualified member of our team and a respected scientist, will take on this new role and further enhance her close collaboration with the R&D team. After decades of bringing diagnostic innovations to the market, our co-founder Erling Sundrehagen is pleased to move into a more consultative role and hand over more of the responsibility to the competent team that he has helped to form and develop. Erling will continue to contribute with his insights, focusing on NT-proBNP and the early phase of developing new products. With Aleksandra as CSO and the strengthening of our R&D team, Gentian is well-positioned to deliver on its growth ambitions,” says Hilja Ibert, CEO of Gentian Diagnostics.

The announced changes will take effect from 1 January 2023.

This information is subject to the disclosure requirements pursuant to the market abuse regulation article 19 and 5-12 of the Norwegian Securities Trading Act.

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)

Kilde

TekBot · desember 15, 2022, 11:51am

Mandatory notification of trade

Moss, 15 December 2022

Reference is made to the annual general meeting 18 May 2022 where a statement of remuneration to key personnel was given. In accordance with this statement the board of Gentian Diagnostics ASA has allocated a total of 219,996 options to key employees under the existing option program.
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The following number of options have been allocated to primary insiders of Gentian Diagnostics ASA:

Hilja Ibert, Chief Executive Officer: 80,000 options. Following the allocations Ms. Ibert holds 6,525 shares and 359,924 options

Njaal Kind, Group Chief Financial Officer: 19,996 options. Following the allocations Mr. Kind holds 21,125 shares and 175,666 options in the Company.

Torsten Knüttel, Vice President R&D: 10,000 options. Following the allocation Mr. Knüttel holds 1,125 shares and 40,000 options in the Company.

Jack Andreassen, Vice President Business Development: 10,000 options. Following the allocation Mr. Andreassen hold 4,385 shares and 32,500 options in the Company.

Markus Jaquemar, Vice President Sales and Marketing: 25,000 options. Following the allocation Mr. Jaquemar holds 47,500 options in the Company.

The exercise price for the options granted is NOK 46,67 being the average volume-weighted share price on the Oslo Stock Exchange from 1 January 2022 to 13 December 2022. The right to exercise the options is vested over a period of 2 years, with 50% of the options vesting by the end of each year as follows: (i) 50% of the options granted, no earlier than 3 years after the allocation date (ii) 50% of the options granted, no earlier than 4 years after the allocation date.

Attached are the notifications of the transactions pursuant to the market abuse regulation article 19.

This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act.

For further information, please contact:

Njaal Kind
CFO, Gentian Diagnostics
E-mail: njaal.kind@gentian.no
Cell Phone. +47 919 06 525

Kilde

TekBot · februar 10, 2023, 12:44pm

Invitation to presentation of fourth quarter results

TekBot · februar 15, 2023, 12:25pm

New study addresses the use of plasma calprotectin in sepsis management

Moss, 15 February 2023

Gentian Diagnostics ASA, a fast growing developer and manufacturer of diagnostic tests, is pleased to announce that the results from a study conducted in collaboration with Karolinska University Hospital, confirming the value of calprotectin in management of patients with suspected sepsis are published in the scientific journal BMC Emergency Medicine with the title “ Plasma calprotectin as an indicator of need of transfer to intensive care in patients with suspected sepsis at the emergency department”.
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The study was performed in patients with suspected sepsis presented at the Emergency Department (ED) at Karolinska University Hospital. Patients with suspected sepsis trigger a sepsis alert, resulting in urgent (within 15 minutes) clinical assessment by a multidisciplinary team of physicians to identify whether infection is present, optimise clinical care and take a decision regarding the level of care. Early recognition and treatment of septic patients have been shown to improve patient outcomes, and it is a need for biomarkers which will support clinical decisions.

The aim of this study was to compare performance of calprotectin and the routinely used biomarkers procalcitonin (PCT), C reactive protein (CRP) and Neutrophil/Lymphocyte Ratio (NLR) in estimation of disease severity and the prediction of the need for admission to intensive care for patients with suspected sepsis.

In total, 592 patients triggered the sepsis alert during the study period, of which 351 were included in the study. Among these, 319 patients had an infection, 66 were transferred to intensive care and 253 to the general ward.

Calprotectin was the only biomarker able to distinguish between patients with bacterial infection and no infection. Moreover, levels of calprotectin were significantly higher in patients transferred to higher level of care compared to patients admitted to the general ward. No similar tendency was observed for PCT, CRP, or NLR.

The study results confirm elevated levels of calprotectin in patients with infection and show superior performance of calprotectin compared to CRP, PCT and NLR in detecting patients with need for direct transfer to intensive care.

Early identification of patients with severe disease requiring higher level of care is of critical importance for optimal patient care and use of healthcare resources. The authors concluded that calprotectin appears to be a useful biomarker in the management of patients with sepsis.

The full study can be accessed using the following link: https://rdcu.be/c5E4U

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)

Kilde

TekBot · februar 16, 2023, 7:01am

Fourth quarter and full year 2022 report

Moss, 16 February 2023

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic tests, today announced its results for the fourth quarter and full year 2022.
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Highlights
• Sales of MNOK 27.9 in Q4 22, up 28% (23% organic growth) from 4Q21
• Full-year sales revenue increased 22% to MNOK 101.6 (21% organic growth) in line with the company’s long-term growth target
• EBITDA was MNOK -1.5 in 4Q22. EBITDA for the full year was MNOK -13.0.
• Patent related to NT-proBNP granted in the US and progress on assay development continued.
• Four strategic distribution agreements with major global IVD companies achieved in 2022, including one announced in 4Q for GCAL

“Even in uncertain times, the global demand for diagnostics continues to be robust and for the fifth consecutive year Gentian delivers sales revenue growth above 20%. While the company is now free cash flow positive pre R&D, we will continue to invest in profitable growth. This to maximise the potential of our established products and the ones in market development, while also bringing new high-impact diagnostic tests to market,” says CEO Hilja Ibert of Gentian Diagnostics.

Gentian converts existing biomarkers to the most efficient automated, high-throughput analysers, which contributes to saving costs and protecting life. The company’s go-to-market strategy has been proven through successful and long-lasting partnerships with globally leading IVD companies such as Beckman Coulter and Roche through Bühlmann Laboratories.

“In 2022 we entered into four partnerships with leading IVD companies, including a contract for GCAL with Siemens Healthineers which has been off to a good start. In Q4, we added another undisclosed partner for international roll-out of this product. In 2023, we plan for continued sales growth enabled by additional proof of clinical evidence, endorsements from key opinion leaders, regulatory approvals and development of existing and new partnerships,” says Ms Ibert.

Webcast
Gentian’s CEO Hilja Ibert and CFO Njaal Kind will present the results today at 10:00 CET, followed by a Q&A session. Join the webcast and submit questions via the following link:

https://attendee.gotowebinar.com/register/6415726643434678875

The webcast will be 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 16 February 2023 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 · februar 20, 2023, 8:53am

Q423 kasse 81,6mNOK. - 33mNOK for siste året. De aktiverer FoU og får dermed pyntet på resultatet. Omsetningsveksten er for lav til at det er troverdig for tidligere mål (1 mrdNOK/40% EBIDTA innen 5-7år, lansert for et par år tilbake). Så da er den GENTiale løsningen å holde på målet, men skippe når målet skal nås. Og slik får de holde på.

https://newsweb.oslobors.no/message/582619

Haltopen · februar 20, 2023, 9:37am

Jeg er heller ikke imponert for å si det mildt. Intetsigende kvartalsrapport. De leverer vekst - men den er altfor lav og imponerer hverken markedet eller DnB som har nedjustert kursmålet.

På kvartalspresentasjonen snakket man om akselerert vekst når avtalene signert i fjor kom i gang for fullt, sammen med nye avtaler som var på gang. Allikevel ser det ikke ut til å være hastverk med å komme seg inn her og/eller øke beholdningen.

Nå begynner også kassebeholdnigen å nå nivåer hvor påfyll kan bli aktuelt - kanske allerede i 2024 om man fremdeles ikke tjener penger innen den tid.

TekBot · mars 17, 2023, 2:46pm

Financial calendar

TekBot · mars 22, 2023, 12:53pm

Health economic model identifies GCAL® as a cost-effective biomarker

Moss, 22 March 2023

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic tests, is pleased to announce the results from a study on health economic impact of use of GCAL® Calprotectin Immunoassay for early detection of infection in intensive care patients. The study has been presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) meeting in Brussels which is currently ongoing.
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A health economic model has been developed, based on the results from a previous study showing the ability of calprotectin to detect bacterial infections before onset of clinical symptoms and antibiotic prescription1.

The model was employed to estimate the cost-effectiveness of analysis of calprotectin for early detection of bacterial infection and thus, the earlier start of antibiotic treatment compared to other diagnostic biomarkers. The base-case results show that predictively measuring of calprotectin in an intensive care unit (ICU) setting, using the GCAL® Calprotectin assay, reduces total costs by approximately 13 000 – 18 000 EUR per patient, overall mortality rate by 0.11, and mean length of stay in an ICU and general ward by 1.3 – 2 days and 6.9 – 8 days, respectively. Compared to procalcitonin (PCT), C-reactive protein (CRP) and white blood cell count (WBC), calprotectin, analysed by the GCAL® Calprotectin Immunoassay, was shown to save total costs, reduce the mean duration of in-patient care, and reduce in-hospital mortality in those patients.

Although the study focuses on a health economic perspective, the main rationale of analysis of calprotectin is from a clinical perspective, since early diagnosis of severe infections and sepsis reduces both delays in treatment and mortality. From this aspect, data from the health economic model support previous studies, where early detection of severe infections and sepsis has both cost-saving and life-saving impact in the ICU setting.

For further information please see the enclosed study poster.

IR Contact:
Njaal Kind, CFO
njaal.kind@gentian.no
+47 919 06 525 (mobile)

Reference: 1. Jonsson, N. et al., Calprotectin as an early biomarker of bacterial infections in critically ill patients: an exploratory cohort assessment. Crit Care Resusc. 2017 19, 205-213.

Kilde

TekBot · mars 30, 2023, 2:50pm

Annual report 2022

TekBot · april 12, 2023, 11:12am

Notice of annual general meeting

Haltopen · april 14, 2023, 7:38am

Styret reduseres med totalt 1 person. Tomas Kramar og Susanne Stuffers går ut. Inn kommer Kjersti Grimsrud, en kjenning fra Axis-Shield tiden.

https://www.linkedin.com/in/kjersti-grimsrud-113a9110/?originalSubdomain=no

Kjersti Grimsrud is President and Chief Operating Officer of Global Continence Care. Kjersti joined ConvaTec from Alere, Inc where from 2014 she was President Europe and the Middle East and President International, with responsibility for a business with revenues of US$720m. She decided to join ConvaTec following the acquisition of Alere by Abbott Laboratories in October 2017.

Prior to Convatec, she was President Europe and the Middle East and President International, at Alere, Inc. Kjersti was a member of the founding team at Axis-Shield, which was acquired by Alere in 2011. Kjersti’s 25 years of experience in the medical technology sector includes over two decades in roles within diabetes care, including General Manager, Operations, Sales, Marketing and R&D positions.

Kjersti holds a Master of Science in Biotechnology from the Norwegian University of Science and Technology.

TekBot · april 14, 2023, 7:25am

Gentian Diagnostics invites to Capital Markets Day

Moss, 14 April 2023

Gentian Diagnostics ASA will host a Capital Markets Day (CMD) on 10 May 2023 at the company’s headquarter in Bjørnåsveien 5, 1596 Moss, Norway. In-person attendance is encouraged. The presentations from the event will be broadcasted live to participants not able to join in person.
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Gentian will present its strategy for growth and long-term value creation which is founded on delivering innovative and efficient diagnostics products. Hence, the focus of the CMD will be to provide additional insights into Gentian’s product strategies and how the company intends to leverage scientific evidence and partnerships with major global diagnostic companies to drive sales growth.

Speakers at the capital markets day will include:

Hilja Ibert – CEO
Njaal Kind- CFO
Aleksandra Havelka – CSO
Markus Jaquemar – CCO
Torsten Knüttel – VP R&D

Programme for the day:
12.00-12.30 CEST: Registration and light lunch
12.30-15.00 CEST: Presentations and Q&A
15.00-16.00 CEST: Site visit

Please register your attendance to the capital markets day using the following link: Form , or send an e-mail to invest@gentian.no

IR contact:
Njaal Kind, CFO
njaal.kind@gentian.no
+47 919 06 525 (mobile)

Kilde

Haltopen · april 21, 2023, 12:13pm

Plutselig litt kjøpsinteresse her? Gir utslag på kursen når aksjener såpass illikvid.

Do2Do · april 21, 2023, 12:16pm

Hadde vært fint med et oppkjøp her

TekBot · april 27, 2023, 8:56am

Invitation to presentation of first quarter results

TekBot · mai 4, 2023, 9:18am

Minutes from Annual General Meeting

TekBot · mai 5, 2023, 5:30am

First quarter 2023 report

Moss, 5 May 2023

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic tests, today announced its results for the first quarter of 2023.
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Highlights
Record sales of MNOK 31.4, up 53% from 1Q22, with organic growth of 40%. All products and geographic areas demonstrated positive sales development in 1Q23 compared to 1Q22.

Demand for Cystatin C in China has stabilised after the end of the corona-related lock-down.

New diagnostic guidelines in the US and co-marketing efforts with commercial partner Beckman Coulter resulted in new customers for Cystatin C in the US and in Europe.

Further results from scientific studies confirmed the clinical relevance and benefits of GCAL for the early detection and severity assessment of infections.

EBITDA was MNOK -0.5 in 1Q23 versus MNOK -4.2 in 1Q22. R&D costs were MNOK 6.6 in the quarter.

“The global demand for diagnostics continues to be robust even in uncertain times, driven by a growing and ageing population. We are continuously innovating diagnostic efficiency to get faster patient results and increase clinical efficiency, and the market response is a clear signal that we are adding real value to our customers. I’m particularly pleased that we deliver growth across all products, all geographies and all sales channels,” says CEO Hilja Ibert of Gentian Diagnostics.

Gentian converts existing biomarkers to the most efficient automated, high-throughput analysers, which contributes to saving costs and protecting life. The company’s go-to-market strategy has proven successful with annual sales growth averaging 28% over the past four years. Gentian’s five revenue-generating products are sold in Europe, the US and Asia. In addition, the company invests in product development with the current pipeline comprising NT-proBNP in product development and further two undisclosed projects in the proof-of-concept phase.

Webcast
Gentian’s CEO Hilja Ibert and CFO Njaal Kind will present the results today at 09:00 am CEST, followed by a Q&A session. Join the webcast and submit questions via the following link:

https://register.gotowebinar.com/register/1605516105712686432

The webcast will be 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 5 May 2023 at 07:30 CET.

Kilde