Gentian Diagnostics

Do2Do · oktober 21, 2021, 6:36am

https://newsweb.oslobors.no/message/544759

Webcast og R&Dpresentation 21. oktober
Webcast
Gentian’s CEO Hilja Ibert and CFO Njaal Kind will present the results today followed by a R&D presentation at 10.00-12.00 CEST. The presentation will be followed by a Q&A session. Join the webcast and submit questions via the following link:

https://attendee.gotowebinar.com/register/1577263042320634384

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

TekBot · november 1, 2021, 12:08pm

New study supports the value of calprotectin in management of COVID-19 patients

Moss, 1 November 2021

Gentian Diagnostics ASA is pleased to announce that the results from a study conducted in collaboration with Charité – Universitätsmedizin Berlin and Labor Berlin have been presented as a poster at the European Society for Emergency Medicine (EUSEM) congress in Lisbon.
…

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The results are part of an ongoing prospective clinical trial (CASCADE) which is performed in the Emergency department of the Charité – Universitätsmedizin Berlin Campus Benjamin Franklin.

The study concluded that the calprotectin levels in plasma were significantly higher in ventilated than in non-ventilated COVID-19 patients. Moreover, calprotectin was able to predict need for Intensive Care Unit (ICU) admission with outstanding performance and an AUROC of 1.0. The performance of calprotectin in prediction of ICU admission was better than performance of the biomarker procalcitonin.

10 COVID-19 patients with positive SARS-CoV-2 PCR test were enrolled and the value of calprotectin in prediction of need for admission to ICU and the need for mechanical ventilation was also investigated.

The conclusion from this study supports calprotectin as an early biomarker for risk stratification and optimal management of COVID-19 patients. Early identification of patients with severe form of the disease is of critical importance for optimal patient care and use of healthcare resources. The authors also confirm that use of Gentian’s calprotectin assay GCAL® supports an easily accessible and efficient measurement of calprotectin in routine laboratories.

For further information please see the enclosed poster.
IR contact:

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

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

TekBot · november 3, 2021, 11:32am

Multicenter study confirms calprotectin’s role in risk stratification in COVID-19

Moss, 3 November 2021

Gentian Diagnostics ASA is pleased to announce that the results from the multicenter study “Circulating levels of calprotectin, a signature of neutrophil activation in prediction of severe respiratory failure in COVID‑19 patients: a multicenter, prospective study (CalCov study)” are published in the scientific journal “Inflammation Research”. The study has been conducted in collaboration with four hospitals in Spain, with the aim to investigate the role of calprotectin in prediction of disease severity, including need for mechanical ventilation and Intensive Care Unit (ICU) admission in patients with Coronavirus disease 2019 (COVID-19).
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The study population included 395 patients presented at four Spanish hospitals of which 57 (14.4%) required invasive mechanical ventilation and 100 (25.3%) were admitted to an ICU. Calprotectin levels were measured at the admission to emergency department and were significantly higher in patients who developed severe respiratory failure (3.73 mg/L vs. 2.63 mg/L; p < 0.001) and/or were admitted to the ICU (3.48 mg/L vs. 2.60 mg/L; p = 0.001). In a multivariate analysis, serum calprotectin was an independent predictor of need for invasive mechanical ventilation and ICU admission.

The authors conclude that the study results support the association of neutrophil activation, characterised by elevated calprotectin levels, with COVID-19 severity. They suggest use of calprotectin in risk stratification at an early stage in patients presented at the emergency department. In a situation with overwhelmed ICUs and limited resources in healthcare systems, an early identification of patients on risk of severe respiratory failure, requiring critical care management, is of key importance. The assessment of calprotectin in combination with other clinical data can be useful for fast triage, timely allocation and effective care of COVID-19 patients.

For further information please see the enclosed research paper.

IR contact:

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

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

Quadruple · november 3, 2021, 12:41pm

Opp og ned går det. Liten interesse for aksjen som ble trukket fram av Stig Myrseth som den mest potente innen sektoren, for ett par år siden. Ambisjoner om milliardomsetning mottas med et gjesp.
Ville det hjelpe med en mer tillitvekkende CEO?
Myrseth er det blitt stille fra. Simply Wall Street mener den er sterkt overpriset. Noen andre?

TekBot · november 29, 2021, 3:23pm

Share Issue in Connection with Employee Share Purchase Program

Moss, 29 November 2021

Reference is made to the annual general meeting held on 4 May 2021 where a resolution to grant an authorisation for a share issue in connection with an employee share purchase program (ESPP) was resolved.
…

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Gentian Diagnostics ASA is pleased to announce that it has decided to conduct a share issue towards company employees that has applied for shares in the ESPP. Under the terms of the ESPP, all employees have been given the opportunity to apply for shares up to a maximum amount of NOK 30,000. The company has decided to award a 25% discount to the volume weighted average price between 19 November and 26 November 2021, resulting in a subscription price of NOK 54.49 per share. More than 50% of the employees have applied for shares for approximately NOK 570,000. Based on the application for shares by the employees, the board has today resolved to increase the company’s share capital by minimum NOK 0.10 and maximum NOK 1046.10 by issuing minimum 1 and maximum 10,461 new shares at a subscription price of 54.49 per shares. The shares will be subscribed for within 10 December 2021.

For further information, please contact:

Njaal Kind
CFO, Gentian Diagnostics
E-mail: njaal.kind@gentian.no
Cell Phone: +47 919 06 525
This information is subject to the disclosure requirements pursuant Oslo Børs Rule Book II

Kilde

TekBot · november 30, 2021, 2:07pm

Mandatory notification of trade

Moss, 30 November 2021

Reference is made to the annual general meeting 4 May 2021 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 165,674 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:

Njaal Kind, Group Chief Financial Officer: 40,674 options. Following the allocations Mr. Kind hold 21,125 shares and 155,670 options in the Company.

Erling Sundrehagen, Chief Scientific Officer: 20,000 options. Following the allocation Mr. Sundrehagen and related parties hold 184,083 shares and 120,000 options in the Company.

Torsten Knüttel, Vice President R&D: 20,000 options. Following the allocation Mr. Knüttel hold 1,125 shares and 30,000 options in the Company.

Jack Andreassen, Vice President Business Development: 2,500 options. Following the allocation Mr. Andreassen hold 4,385 shares and 22,500 options in the Company.

Markus Jaquemar, Vice President Sales and Marketing: 2,500 options. Following the allocation Mr. Jaquemar holds 22,500 options in the Company.

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

The exercise price for the options granted is NOK 72.60 being the average volume-weighted share price on the Oslo Stock Exchange for the past 10 trading days prior to 24 November. The right to exercise the options is vested over a period of 3 years, with 1/3 of the options vesting by the end of each year as follows: (i) 1/3 of the options granted, no earlier than 2 years after the allocation date (ii) 1/3 of the options granted, no earlier than 3 years after the allocation date (iii) 1/3 of the options granted, no earlier than 4 years after the allocation date.

For further information, please contact:

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

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.

Kilde

TekBot · desember 9, 2021, 2:03pm

Share capital increase registered

Moss, 9 December 2021

Reference is made to the stock exchange notice from Gentian Diagnostics ASA (the
…

Vis børsmeldingen

“Company”) on 29 November 2021 regarding a share issue in connection with an
employee share purchase program (ESPP), by issuance of 10,641 new shares in the
Company at a subscription price of NOK 54.49 per new share. The share capital
increase pertaining to the ESPP is now registered with the Norwegian Register of
Business Enterprises. The Company’s new registered share capital is NOK
1,542,235.0 divided on 15,422,350 shares, each with a nominal value of NOK 0.10.

This information is subject to the disclosure requirements pursuant to section
5-12 of 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 · desember 10, 2021, 8:43am

Share capital increase registered - Correction*

Moss, 9 December 2021

Reference is made to the stock exchange notice from Gentian Diagnostics ASA (the
…

Vis børsmeldingen

“Company”) on 29 November 2021 regarding a share issue in connection with an
employee share purchase program (ESPP), by issuance of *10,461 new shares in the
Company at a subscription price of NOK 54.49 per new share. The share capital
increase pertaining to the ESPP is now registered with the Norwegian Register of
Business Enterprises. The Company’s new registered share capital is NOK
1,542,235.0 divided on 15,422,350 shares, each with a nominal value of NOK 0.10.

This information is subject to the disclosure requirements pursuant to section
5-12 of 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 · desember 16, 2021, 7:35am

Gentian Diagnostics presents at the DNB Nordic Healthcare Conference

TekBot · desember 16, 2021, 7:47am

Completed development of SARS Cov-2 antibody assay

Moss, 16 December 2021

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of innovative and efficient diagnostics for better treatment decisions, has completed the technical development of its novel SARS-Cov-2 antibody immunoassay. This will be the first assay available on high-throughput open-access clinical chemistry platforms for detection of antibodies against SARS CoV-2 virus. The assay will be easily accessible and efficient, and holds potential to speed up the determination of immunisation status in society and support vaccination efforts.
…

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The company will now submit the required documentation for CE-marking of the test and begin preparing for full-scale production. Finalisation of the regulatory approval is expected to allow for a commercial launch of the SARS-Cov-2 antibody assay in February 2022.

“The recent resurgence of Covid-19 cases highlights the need for reliable high-throughput tests to manage the pandemic. With up to 2000 tests per hour we are confident that our new SARS-Cov-2 test can increase capacity and laboratory efficiency significantly. Our assay can be used on all instrument platforms with no additional infrastructure or workflow costs.”, says CEO Hilja Ibert in Gentian Diagnostics.

The SARS-Cov-2 test will add to Gentian’s diagnostics test portfolio including four established products, the GCAL infection and inflammation assay, which is in market development, and the NT-proBNP, congestive heart failure test which is in product development.

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

Boms · desember 16, 2021, 8:17am

Hallo folkens
Ingen som følger med. Dette er gode nyheter og aksjen ligger helt stille.

Se på caset og kjøp før DnB presentasjon som er litt senere i dag.

TekBot · desember 16, 2021, 12:33pm

Financial calendar

TekBot · januar 31, 2022, 1:01pm

Global GCAL® distribution contract with Siemens Healthineers

Moss, 31 January 2022

Reference to the stock exchange release dated 5 October 2021 and the 3rd quarter report released on 21 October 2021, Gentian Diagnostics ASA, a fast-growing developer and manufacturer of innovative and efficient diagnostics for better treatment decisions, has entered a global distribution contract for the Gentian Calprotectin Immunoassay GCAL® with Siemens Healthineers. The GCAL® assay will be offered on the Siemens Healthineers BN™ II, BN ProSpec®, and Atellica® NEPH platforms and positioned toward the rheumatoid arthritis market, with launch scheduled for the first half of 2022. Siemens Healthineers is a market leader in nephelometric plasma protein testing.
…

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The GCAL® assay is available for quantitative measurement of calprotectin in plasma and serum, which is an early biomarker for detection and assessment of the inflammatory response to severe infections and other inflammatory conditions like rheumatoid arthritis. The Siemens Healthineers BN II platform is a fully automated system with a large installed base, and additional systems from Siemens Healthineers are scheduled to be added at a later stage.

“This is an important milestone for Gentian, as this makes our innovative GCAL® assay readily available for a larger patient group. Siemens Healthineers is one of the global leaders in clinical diagnostics, with its large installed base of laboratory testing systems and assays,” says Gentian Diagnostics CEO Hilja Ibert.

The GCAL® assay will initially be made available in Europe, with expansion to additional countries or regions depending on regulatory clearance.

Rheumatoid arthritis is a chronic inflammatory autoimmune disease affecting more than 1% of the adult world population, and early detection is critical to ensure prevention of disabling joint erosion. Industry analysts estimate the value of the rheumatoid arthritis diagnosis test market at more than USD 550 million in 2020, with growth potential to more than USD 750 million by 2027, and the serviceable market for GCAL in this segment is estimated at USD 30–60 million.

Earlier in 2021, Gentian outlined the roadmap for its portfolio of high-impact diagnostic tests, which supports the company’s revenue growth ambitions. The company expects GCAL® to be one of the main value drivers in the realization 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)

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 31 January 2022 at 14:00 CET.

Kilde

Do2Do · februar 6, 2022, 6:21pm

Fra melding 16. desember 2021.

Hva kan vi forvente av dette produktet for GENT? Hvilke deler av testmarkedet skal GENT adressere - og hvor stort er det segmentet? Infrastruktur og volumer i tester og inntjening? Konkurransesituasjonen?

Testmarkedet vil trolig være big business de kommende årene:

The global COVID-19 diagnostics market is projected to drop from $20.05 billion in 2021 to $9.20 billion in 2028 at a CAGR of -10.5% in forecast period… Read More at:

COVID-19 Diagnostics Market Size, Share | Report [2028]

https://www.globenewswire.com/news-release/2021/10/21/2318216/0/en/COVID-19-Diagnostics-Market-Size-2020-2027-is-Projected-to-Reach-USD-11-40-Billion-exhibiting-a-CAGR-of-7-9.html

Haltopen · februar 7, 2022, 8:31pm

Svimlende summer, men akkurat dette med antistoff-testing er litt i det blå. Hvor viktig og stort dette markedet er og blir er vanskelig å si noe om. Mye avhenger trolig av myndighetenes plan for overvåking av viruset. Ser man på fda og ema sine sider er det lite med konkrete anbefalinger på nåværende tidspunkt.

Gentian selv skriver antistofftest har et totalt marked på 2 USDbn, mens Gentian sitt serviceable market er på 20 USDm (Norden?) og med antatt markedsandel på 25% enden man opp med 5 USDm.

Det er klart oppsiden er stor her hvis man øker til EU og videre.

Siemens er iallfall bull
Antibody Testing Is Critical in Overcoming the COVID-19 Pandemic—Now and in the Future

Antibody tests play an important role throughout the patient care pathway and are vital for the management and surveillance of the virus. They are critical in determining the full scope of the disease, combating the pandemic, and rebuilding public confidence.

Highly accurate antibody tests help inform clinical and public health decisions as we look towards safely opening our communities. Antibody tests can be used for the following:

As an adjunct to PCR tests to aid in clinical assessment
To help determine prior exposure to the virus, by detecting antibodies that may neutralize the virus
To identify potential donors of convalescent plasma
For epidemiological purposes including establishing prevalence of disease in populations
May help verify effectiveness of vaccines as they become available

TekBot · februar 11, 2022, 9:44am

Invitation to presentation of 2021 fourth quarter results

TekBot · februar 17, 2022, 7:01am

Fourth quarter and full year 2021 report

Moss, 17 February 2021

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic tests, today announced its results for the fourth quarter and full year 2021.
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Highlights

• Total operating revenue of NOK 26.2 million in Q4 2021, up 10% from Q4 2020. EBITDA of NOK -8.5 million, of which NOK -4.4 million related to implementation of new ERP system.
• Sales revenue of NOK 21.7 million, +26% from Q4 2020, with organic growth at 33%.
• Finalised negotiations with Siemens Healthineers for commercial roll-out of GCAL®, with contract signed in Q1 2022
• Completed development of the SARS CoV-2 assay, with launch planned during Q1 2022
• NT-proBNP remains in optimization and timing remains uncertain.

Gentian achieved 31% sales growth to NOK 83.1 million for the full year 2021, with organic sales growth at 43%.

“We see continued strong growth for our established portfolio, particularly for Cystatin C and fCAL®turbo. Sales are being driven by increased adoption of Cystatin C as a routine marker for chronic kidney disease, and by strong demand in China and South Korea. We are also expanding our commercial footprint including third party sales in Norway, Finland and Iceland,” says CEO Hilja Ibert of Gentian Diagnostics.

The company sees continued double-digit sales growth for the established product portfolio also going forward and expects to see significant sales growth for GCAL®.

“The global distribution agreement signed with Siemens Healthineers earlier this year will make our innovative GCAL® assay readily available for a larger patient group,” adds Ibert. Launch of GCAL® on Simens Healthineers platforms is scheduled for the first half 2022.

The company also plans for a launch of its SARS Cov-2 assay during the first quarter of 2022, following completion of development late in 2021.

As previously announced, the optimisation of NT-proBNP has been more complex that first assumed. While the company has made progress with particle coating and stability and show reproducible results in a controlled environment, there are remaining challenges with interference between the NT-proBNP molecule in clinical plasma. Work is ongoing to reveal and remove the interference source. The timing of the NT-proBNP project remains uncertain, and the company will not communicate a revised timeline until the optimisation phase has been completed.

For more information please find enclosed the Q4 report and presentation.

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/2806581916191976462

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 17 February 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 · februar 26, 2022, 4:13pm

TekBot · februar 28, 2022, 11:21am

Mandatory notification of trade

TekBot · mars 29, 2022, 7:38am

Release of the Gentian SARS-CoV-2 Total Antibody Immunoassay

Moss, 29 March 2022

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of innovative and efficient diagnostics for better treatment decisions, is pleased to announce the release of the novel CE marked SARS-CoV-2 Total Antibody Immunoassay. This is an open channel immunoassay for use on high-throughput clinical chemistry analysers.
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“The need for reliable high-throughput antibody tests increases in the post-vaccine phase of the COVID-19 pandemic, to follow, document and manage efficient population immunity. With up to 2,000 tests per hour we are confident that our new SARS-CoV-2 test can increase capacity and laboratory efficiency significantly. Our assay can be used on all instrument platforms with no additional infrastructure or workflow costs.”, says CEO Hilja Ibert in Gentian Diagnostics.

Gentian’s SARS-CoV-2 Total Antibody Immunoassay captures the full immune response detecting total antibody levels targeting the S1-subunit of SARS-CoV-2. The assay is fully aligned with the WHO International Standard for quantitative measurements.

The Gentian assay is easily accessible and efficient and is intended to identify patients with an adaptive immune response to SARS-CoV-2 that indicates recent or prior infection or a successful response to vaccination. It will provide a powerful high-throughput test for community management of COVID-19 through long-term monitoring of natural and vaccine-related immune response, with the potential to aid future vaccination evaluation and strategy.

Gentian’s turbidimetric SARS-CoV-2 Total Antibody Immunoassay has been developed in collaboration with the University in Tromsø (UiT). The SARS-CoV-2 test will add to Gentian’s diagnostics test portfolio including four established products, and the GCAL® infection and inflammation assay which is in market development. Initial market focus will be on the Nordic countries, with subsequent commercial expansion into additional European geographies.

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