Takk. Interessant at hjerte markøren presenteres som et tilgjengelig produkt, forhåpentligvis bekreftet i børsmelding snart

Enda en distribusjonsavtale for Cystatin C!

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.

“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.

https://newsweb.oslobors.no/message/569400

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
- 2022: Direktesalg til kunder i USA
- 20.04.2022: Gentian Diagnostics signs distribution agreement with leading global diagnostics company for Cystatin C (USA)
- 23.08.2022: entered into a distribution agreement for the Gentian Cystatin C Immunoassay with a global diagnostics company (USA & Canada).

Onsdag 24. august besøker helse- og omsorgsminister Ingvild Kjerkol Moss, Fredrikstad og Mysen.

Statsråden innvier dei nye lokala til Gentian diagnostics ASA. Bedrifta har fleire norskutvikla diagnostikk-produkt, inkludert antistoff-test for covid-19. Statsråden får omvising der ho får sjå heile arbeidsflyten i produksjonen frå start til slutt. Deretter innvier ho dei nye lokala.

https://www.regjeringen.no/no/aktuelt/helse-og-omsorgsminister-ingvild-kjerkol-besoker-moss-fredrikstad-og-mysen/id2924841/

https://www.healthtalk.no/diagnostikk/gentian-diagnostics-rigger-seg-for-milliardomsetning/161231

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

Highlights
* Record sales of MNOK 30.1 in 2Q22, up 22% and 19% organically from 2Q21 despite COVID-19 related logistics challenges in China

* An additional distribution agreement with a global diagnostics company for Cystatin C announced post quarter with initial rollout in North America

* Established a Scientific Advisory Board for GCAL® with Key Opinion Leaders from Europe and participation from Siemens Healthineers to further accelerate market development

* Good progress made on NT-proBNP, promising new immonuparticle candidate identified

* Successfully completed extension of the lab and production facilities in Moss designed to support long-term revenue ambition

* Current demand and commercial progress support ambition of 20% annual sales growth from established products, with further upside from products in market development

“For the second half of 2022, we aim to expand our footprint through additional regulatory approvals including IVDR, and further clinical studies and endorsements from key opinion leaders. We are also working on maturing our three projects currently in exploration and proof of concept phases with the aim to broaden our product portfolio and addressable market,“ commented Hilja Ibert, CEO of Gentian Diagnostics.

For NT-proBNP, earlier issues related to interference and signal strength appear less pronounced following the identification of a promising new immunoparticle candidate during the second quarter. More investigations are still required to further improve signal strength and clinical samples must be tested to reproduce early findings.

Fra rapporten:
Pipeline: In the exploration phase, the company is investigating a wider selection of biomarkers. Several projects are in the pipeline to be further evaluated for their acceptability to move from the exploration phase into the proof-of-concept phase.

The development of the pipeline project in proof-of-concept is progressing well. A market sensing project has been finalized and a market opportunity has been identified, providing the company with a set of recommendations regarding product development priorities and target markets for the product.

An evaluation of the GCAL® assay and an establishment of a reference interval in the paediatric population has taken place in collaboration with the Hospital for Sick Children, Toronto, Canada. Data from the study have been presented as a poster at the AACC (American Association of Clinical Chemistry) congress, which took place in Chicago from July 24 to July 28, 2022. The data confirmed significantly higher concentrations of calprotectin in children with obesity and neonates with suspected bacterial infection relative to healthy subjects indicating the value of the GCAL® assay in detection of bacterial infections in the paediatric population.

A Scientific Advisory Board for GCAL® was established during the quarter with the overall objective of engaging key opinion leaders in
expanding the market awareness of the assay, its benefits and relevant applications. The first meeting was held on June 3rd in Frankfurt. Members of the board include Dr Camille Chenevier-Gobeaux, Hôpital Cochin, APHP. Centre – Université de Paris, Prof. Dr. Michael Bauer, Center for Sepsis Control and Care (CSCC) University Hospital Jena, Germany, Dr. Lenard Mueller, Senior Marketing Manager, Siemens Healthineers. The key topic of this first meeting was patient centred benefits and biomarker guided therapy of severe infections and sepsis in context of GCAL®.

Hadde forventet en omsetning på >30 millioner kr ville resultere i positivt resultat, men det endte på -2.9 millioner kroner. Allikevel er det selvfølgelig positivt med rekordomsetning, og det uten nevneverdige bidrag fra Cystatin C i USA. Da tolker jeg det som vi har mer i vente fremover, og kan kanskje forvente >30 millioner i omsetning heretter? Er dette første tegn på at det omsider begynner å løsne for selskapet?

Mandatory notification of trade

Moss, 25 August 2022

Gentian Diagnostics ASA has today been notified that the following transaction has been completed by a primary insider in Gentian Diagnostics ASA: Monika Neuman, board member and primary insider in Gentian Diagnostics ASA, has today bought 800 shares at an average price of NOK 43.00 per share. After the transaction, Monika Neuman holds 800 shares in Gentian Diagnostics ASA.

Litt skuffende påvirkning på kursen. Tallene var jo veldig gode og alt tyder vel på sterk vekst og verdiskapning fremover. Hvorfor mer eller mindre uteblivelse av reaksjon i markedet?

Det er typisk for aksjen. Liten til ingen interesse. Den kommer trolig med økende vekst og overskudd. I dagens marked er ikke vekstselskap særlig "hot".

Hva tror du skal til for å endre på det?

Innside kjøp av Holta / Andenæs representanter i styret, og/eller av CEO/CFO, hadde nok satt litt fart i kursen

Et innsidekjøp som monner hadde definitivt hjulpet. Ved Q2'21 kjøpte Runar Vatne 100k aksjer.

Andre triggere er:
- NT-proBNP over til neste utviklingsfase
- GCAL partnerkontrakt og/eller calprotectin får større fokus og tas i bruk for bl.a. sepsis (liker etableringen av Scientific Advisory Board). Alternativt at Siemens kjører GCAL ut globalt og ordner godkjenning i USA og Kina.
- Proof of Concept for ny test
- Ny teknologi sammen med partner (Point of Care)
- Tresifret vekst i USA og positiv bunnlinje

Og så har man makro hvor man kan få en rotasjon inn i vekst og tech igjen.

Litt mer tyngde i dette innsidekjøpet:

Mandatory notification of trade
Moss, 29 August 2022

Gentian Diagnostics ASA has today been notified that the following transaction has been completed by a primary insider in Gentian Diagnostics ASA: Frank Frantzen, board member and primary insider in Gentian Diagnostics ASA, has today bought 20,000 shares at an average price of NOK 43.50 per share. After the transaction, Mr. Frantzen holds 20,000 shares in Gentian Diagnostics ASA.

Innsidekjøp på i underkant av 900.000kr må da definitivt påvirke kursen. Her er det noen tett på informasjonen som har troen. Glimrende!

Gentian Diagnostics: Njaal Kind CFO presents at Redeye Diagnostics Seminar 2022

https://www.redeye.se/video/event-presentation/856469/gentian-diagnostics-njaal-kind-cfo-presents-at-redeye-diagnostics-seminar-2022?utm_source=avanza&utm_medium=RSS

Ikke gæren omtale fra e24 dette.

https://e24.no/boers-og-finans/i/RGG3Va/gentian-venter-flere-avtaler

Nå har jeg bare en liten lyttepost i Gent, og kunnskapen min om selskapet når ikke f.eks Haltopen til ankelen, men følger litt med, selv om posten er liten. Dog, den er spennende ;)

Velkommen skal du være Hellboy!

Angående Q3:

GENTIAN DIAGNOSTICS
Largely on track

With Q3 sales in line, the announcement of a new partnership, and the successful onboarding of a recently announced partnership, we see many positives. The NT- proBNP efforts are progressing, but the outcome is still uncertain. Despite this, we consider Gentian attractively valued and reiterate our BUY and NOK90 target price.

Q3 review. Product sales were cNOK23.1m, with 35% organic growth YOY. Sales were largely driven by Cystatin C and fCAL@turbo, together accounting for more than 75% sales. While sales were in line with our estimate (Q3 tends to be seasonally weak), EBITDA was cNOK-6.1m (we forecast cNOK-3m). The company’s financial position remains solid in our view, with an end-Q3 cash position of cNOK93.9m.

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

Noen kommentarer? Ingen påvirkning på kursen selv om Gentian selv mener dette er en «viktig milepæl».

Et patent er vel og bra, men skal NTproBNP dra kursen opp må det mer til; et steg videre i utviklingsløpet og over i verifikasjonsfasen.

Lite som skjer rundt Gent for tiden. Siste melding fra selskapet var at Sundrehagen går ut av rollen som CSO og inn som Consulting Founder og skal bruke all tid og kompetanse på utvikling av NT-proBNP. Det er nok et riktig steg for selskapet og 71-åringen selv.

Rundt om tikker det fremdeles inn mange artikler og forskningsresultater rundt Calprotectin. Nå som Covid er på vei opp igjen får muligens GCAL mer vind i seilene rundt diagnostisering av Covid severity?

Serum calprotectin can indicate current and future severity of COVID-19
First published: 16 December 2022

Calprotectin can be used as a reliable prognostic tool to predict the poor clinical outcomes of COVID-19 patients.
https://onlinelibrary.wiley.com/doi/full/10.1002/jcla.24809


I tillegg dukker det opp flere og flere artikler rundt mulige diagnostiske områder for calprotectin

Calprotectin as a diagnostic marker for sepsis: A meta-analysis
Conclusion: On the basis of our meta-analysis, calprotectin is a helpful marker for early diagnosis of sepsis on ICU admission
https://www.frontiersin.org/articles/10.3389/fcimb.2022.1045636/full

Serum Calprotectin Is a Valid Biomarker in Distinction of Bacterial Urinary Tract Infection From Viral Respiratory Illness in Children Under 3 Years of Age
Conclusion: sCal could have substantial added value in the management of a child with fever and positive urinalysis and is a promising biomarker in distinction between bacterial UTI and viral respiratory causes of febrile illness in children under the age of 3 years.
https://www.frontiersin.org/articles/10.3389/fped.2022.768260/full

Serum calprotectin could indicate inflammatory activity in tocilizumab-treated RA patients
These findings indicate that “[c]alprotectin in the serum can be a useful inflammation parameter despite [tocilizumab]-treatment,” say Gernert et al.
https://rheumatology.medicinematters.com/rheumatoid-arthritis-/biomarkers/calprotectin-tocilizumab/23590782

Serum Calprotectin Level as an Inflammatory Marker in Newly Diagnosed Hypertensive Patients
Considering all these findings of the present study together, we think that the place of calprotectin in hypertension now deserves to be examined in a greater detail.
https://www.hindawi.com/journals/ijhy/2022/6912502/

Serum calprotectin: a new potential biomarker for psoriasis?
Undoubtedly, these results strengthen the idea to using serum calprotectin as a new biomarker in psoriatic patients, but this use remains controversial.
https://www.minervamedica.it/en/journals/minerva-medica/article.php?cod=R10Y2022N05A0761&html=1&htmlID=MFZYLzZBZE81cHBOb09mS1FMNC9sZjNpcGVlUVJaK3Q4aXNhU0E4RVl6T0d2eC9GUys0R08vSUhJV0FjZjlaYQ%3D%3D

GCAL® - Plasma and serum calprotectin in routine use
15. Dec 2022
Two institutions using GCAL® in routine at their institutions are Labor Berlin – Charité Vivantes GmbH in Germany and the Assistance Publique-Hôpitaux de Paris (APHP Centre) in France.

Labor Berlin experienced an increasing demand for plasma and serum calprotectin testing, and therefore wanted to implement an automated solution for plasma and serum calprotectin. APHP was searching for additional biomarkers to complement routine biomarkers like CRP, IL-6 during the 1st COVID-19 wave, looking for a biomarker that would better stratify severity and prognosis

https://www.gentian.com/news/plasma-serum-calprotectin-routine-use

Haltoppen, hva er dine spådommer for 2023?

Håpet er i det minste at 2023 blir bedre enn 2022 som, sett bort fra partneravtaler for CysC og Gcal, har vært ganske skuffende.

2023 ser ut til å bli et år uten ny markør på markedet. Tidligere ambisjon om èn ny markør på markedet per år er nå i det stille endret til "Bring a steady stream of high-impact diagnostic tests to market." Dette er utvilsomt pga. uforutsette utfordringer med NT-proBNP som har tatt mye mer tid og ressurser enn først antatt. Nå lider produktutviklingen av det.

Der hvor produktutviklingen svikter har forretningsutviklingen vist bedre takter med to avtaler for GCAL og to avtaler for Cystatin C i 2022. I tillegg har Gentian åpnet nye lokaler og har nå kapasitet til å levere mye større volum enn tidligere. Det vil si at mye ligger til rette for økt omsetning av eksisterende produkter.

Spådommer for 2023:
- NT-proBNP omsider over til verifikasjon og valideringsfasen. Launch ser dessverre ut til å glippe for 2023
- Ny markør over i optimiseringsfasen. Basert på type markør og markedspotensial kan dette skape litt blest
- Potensielt enda en markør over i optimiseringsfasen. Hvis jeg ikke husker helt feil er det to markører i proof-of-concept fasen nå.
- Økt salg i USA for Cystatin C. Med to nye avtaler har man grunn til å forvente mer i USA enn dags dato.
- Økt salg av GCAL i Europa. To nye avtaler her også, og Calprotectin ser ut til å få mer og mer oppmerksomhet som markør i flere ulike indikasjoner.
- fCAL og fPELA får kanskje et lite gjennombrudd i USA? Bühlmann og Roche er forhåpentligvis ivrige etter en launch der; hvor både fPela og fCal er godkjente.

Alt dette bør sørge for at Gentian begynner å tjene penger. Jeg forventer 2023 blir året for pluss i regnskapet.

Så vet man også at selskapet holder kortene tett til brystet. Ut fra offentlige tilskudd vet man at det jobbes med Point-of-Care f.eks., og det kan komme en kanin opp av hatten i løpet av neste år. Partneravtale(r) for NT-proBNP kan også være en kandidat - dersom produktutviklingen får fremdrift.
To nye styremedlemmer; både med kommersiell og vitenskapelig bakgrunn. Begge kjøpte aksjer på sensommeren (Monika N: 800 aksjer, Frank F: 20 000 aksjer, og eksisterende styremedlem Tomas K: 2166 aksjer, 25.08.2022)

Usikkerhetsmomenter er inflasjon og supply shortage, og Kina sin håndtering av Covid. Hvordan dette vil påvirke sektoren for 2023 er høyst usikkert.

Jeg er forsiktig optimist. Ønsker å se flere tegn til bedring før jeg øker beholdningen. Flere innsidekjøp, økt omsetning/salg og positive bidrag fra produktutviklingen.

DnB anbefaler fremdeles kjøp og har kursmål 90 kr/aksjen.

31.01.2022: Global GCAL® distribution contract with Siemens Healthineers - Launched
27.10.2022: Gentian Diagnostics signs distribution agreement with a major diagnostic company for the GCAL® Calprotectin Immunoassay - Launch 1H 2023

20.04.2022: Gentian Diagnostics signs distribution agreement with leading global diagnostics company for Cystatin C - Launched 2H 2022 (?)
23.08.2022: Gentian Diagnostics signs distribution agreement for Cystatin C - Launch 2H 2022

For å gjøre samme eksersis for Cystatin C som Calprotectin. Her er et knippe utklipp fra vitenskapelige artikler fra fjoråret for CystC:

Collaborative Study Reveals Cystatin C is a More Accurate Indicator of Renal Function Than Creatinine
13 December 2022

In a collaborative study between pharmacy and nephrology faculty at the University of California, Irvine and the Department of Medicines from the University of Mississippi Medical Center and Houston Methodist, a group of researchers found that analyzing the protein cystatin C is a more accurate indicator of renal function than creatinine.

https://pharmsci.uci.edu/2022/12/13/collaborative-study-reveals-cystatin-c-is-a-more-accurate-indicator-of-renal-function-than-creatinine/


Circulating Cystatin C Is an Independent Risk Marker for Cardiovascular Outcomes, Development of Renal Impairment, and Long‐Term Mortality in Patients With Stable Coronary Heart Disease: The LIPID Study
18 Feb 2022

Cystatin C independently predicted major cardiovascular events, development of chronic kidney disease, and cardiovascular and all‐cause mortality. Prediction of long‐term mortality was independent of improved estimation of GFR

https://www.ahajournals.org/doi/10.1161/JAHA.121.020745


Utilization of Cystatin C in the Outpatient Setting

Use of Cystatin C is increasing and has moved beyond the nephrology community and the original indications from the 2012 KDIGO guidelines. Community utilization of cystatin C measurement is likely to expand, and understanding of the relationships between estimating equations will help clinicians optimize their use in the outpatient setting.

https://www.karger.com/Article/Abstract/524850


Diagnostic value of serum cystatin C for diabetic nephropathy: a meta-analysis
Juni 2022

Serum cystatin C has an excellent diagnostic value with good sensitivity and specificity for diabetic nephropathy.


Prognostic Performance of Cystatin C in COVID-19: A Systematic Review and Meta-Analysis

Cystatin C is a potentially very good marker to be used in the context of COVID-19 disease due to the prognosis of patients' serious condition, risk of AKI and mortality. In addition, Cystatin C could be used as a marker of renal complications in COVID-19 other than AKI due to the need to monitor patients even longer after leaving the hospital.

https://pubmed.ncbi.nlm.nih.gov/36361485/

Gentian har nå tre partneravtaler for Cystatin C:
- Avtale (global) med Beckman Coulter
- Avtale (US) med et av verdens største diagnostikkselskaper (April 2022)
- Avtale (US & Canada) med et globalt diagnostikkselskap (August 2022)

Har utviklet ny formel for å beregne nyrefunksjon
Forskere ved Universitet i Tromsø har vært med på å utvikle en ny metode for å beregne nyrefunksjonen.

Den nye formelen ble i forrige uke publisert i en studie i New England Journal of Medicine. Den er utført sammen med forskere i European Kidney Function Consortium (EKFC).

– Ved å slå sammen data fra studier som har målt nyrenes funksjon nøyaktig, har vi nå utviklet en ny formel, forteller Toralf Melsom i en pressemelding.

Den nye EKFC-formelen kan bruke enten kreatinin, cystatin C eller begge filtrasjonsmarkører samlet. Metoden er tilpasset populasjonen den brukes i (ved bruk av for eksempel europeisk referanse-nivå for kreatinin og cystatin C) men bruker ikke rasevariabelen, står det i pressemeldingen.

https://www.dagensmedisin.no/forskning-nyresykdom-universitetet-i-tromso-uit/har-utviklet-ny-formel-for-a-beregne-nyrefunksjon/510870


Cystatin C–Based Equation to Estimate GFR without the Inclusion of Race and Sex

The use of tests to measure cystatin C is still not widespread, possibly because of their cost.24 However, our data underscore an additional advantage of their adoption, because unlike serum creatinine, a cystatin C–based equation does not require sex or race variables for the determination of estimated GFR.

https://www.nejm.org/doi/full/10.1056/NEJMoa2203769

Da har omsider usikkerheten rundt utviklingen av NT-proBNP gitt utslag i kursmålet til DnB. Oppdatering 30.01.2023

GENTIAN DIAGNOSTICS
Uncertainty weighs
While we expect sales growth to remain strong, we have lowered our sales estimates to reflect the uncertainty related to the successful development of NT-proBNP and limited visibility in the pipeline. We also now assume somewhat slower margin gains. As a result, we have cut our target price to NOK52 (90); however, we still see the stock as attractively valued at the current share price and reiterate our BUY

Expecting still-strong sales growth. We expect Gentian Diagnostics to continue to report >20% annual sales growth short-term (primarily driven by Cystatin C and fCal) given increased market penetration through partnerships. Medium- and long-term, we assume increasing sales of GCal and potentially NT-proBNP in high-value markets, but slowing growth in existing products as they reach (our estimate of) peak market shares.

Det kan vise seg at strategien om å satse alt på NT-proBNP (vs. andre kandidater i pipeline) var feil. Hvis man ikke snart får et gjenombrudd i utviklingen av den markøren kan resultatet bli 3-4 år uten nytt produkt på markedet. Det er på ingen måte godkjent fra R&D-avdelingen.

Man får nå håpe Q4 viser positive tegn fra både R&D og Business Development.

Det har vært en del volum de siste dagene/ukene.

Det lå en skjult kjøper på 40 kr/aksen frem til i går. Det ser ut som Carpe Diem Afseth står bak de kjøpene på rundt 30k aksjer. Han har økt med over 100k aksjer så langt i 2023.

I dag lå det 25k åpent på kjøp på 40 kr/aksjen. Den posten fikk fill.

Så, hvem selger? For det meste småaksjonærer, og Salix AS fra topp 50.

Topp 50 sitter på 13 841 500 aksjer, 89,7642%

Tidligere styreleder Afseth stod bak det åpne kjøpet på 25k også. Han er nå 7. største aksjonær. Salix solgte.

Hvem som gjorde best deal der får vi svaret på til uken (torsdag).

Plasma calprotectin as an indicator of need of transfer to intensive care in patients with suspected sepsis at the emergency department
11 Feb 2023

Deciding whether to transfer patients with sepsis from the emergency department (ED) to intensive care units (ICUs) is challenging. We hypothesised that the new biomarker plasma calprotectin (p-calprotectin) could be used to aid the selection of patients for intensive care transfer, since it has been shown to be a promising tool for the determination of sepsis severity in critical care.

Conclusions
In sepsis alert patients, p-calprotectin was significantly elevated in patients who were subject to immediate ICU/HDU transfer after assessment by a multidisciplinary team. P-calprotectin was superior to traditional biomarkers in predicting the need for transfer to the ICU/HDU.

For all patients with written informed consent, plasma samples were thawed and analysed for p-calprotectin, using a specific particle-enhanced turbidimetric assay (Gentian Diagnostics AS; Moss, Norway).

https://bmcemergmed.biomedcentral.com/articles/10.1186/s12873-023-00785-y

NEWS RELEASE 14-FEB-2023
Cystatin C shows promise as an additional biomarker to calculate kidney function and stage chronic kidney disease
Peer-Reviewed Publication
BRIGHAM AND WOMEN'S HOSPITAL

“Our study shows that utilization of cystatin C can lead to changes in CKD staging, which can impact clinical management,” said Mallika Mendu, MD, Associate Chief Medical Officer, Associate Professor of BWH’s Nephrology Division, and senior author of the study. “Nationally, there should be a focus on making this important test affordable and accessible to a wide, diverse spectrum of patients.”

https://www.eurekalert.org/news-releases/979726

Der kom melding fra GENT angående studien fra Karolinska

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”.

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.

https://newsweb.oslobors.no/message/582501

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.

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

Ganske kjedelig og helt på det jevne. Ingen overraskelser i positiv eller negativ forstand. Ingen tegn til at det skal løsne og få akselerert salgsvekst.

Litt annen (positiv?) ordlyd rundt NT-proBNP.

No new technical challenges identified
• Tested additional clinical samples using the working prototype which confirmed the hypothesis that the glycosylation of the NT-proBNP molecule can lead to an underestimation of true NT-proBNP concentrations
• A simpler and more efficient calibration method has been developed
• Calibration strategy aims to achieve cut-off levels that are equivalent to established market standards and address the issue of underestimation caused glycosylation
• Received positive and continued interest from IVD companies as potential partners


Av annet nytt har Afseth økt med 100 000 aksjer på dagens lister. Salix selger.

New Guideline Recommends Blood & Stool Tests for Monitoring Ulcerative Colitis
02.03.2023

In new evidence-based guidelines, the American Gastroenterological Association (AGA) recommends non-invasive biomarkers as a first-line strategy for monitoring many patients with ulcerative colitis (UC). These guidelines were published today in Gastroenterology.

The AGA guidelines outline use cases for three biomarkers that provide accurate insights into ulcerative colitis disease activity: serum C-reactive protein (CRP) (blood), fecal calprotectin (stool) and fecal lactoferrin (stool).

AGA recommends stool-based biomarkers over blood testing.

https://reachmd.com/news/new-guideline-recommends-blood-stool-tests-for-monitoring-ulcerative-colitis/2450322/

Circulating Calprotectin (cCLP) in autoimmune diseases

Our review summarizes the widespread interest in circulating CLP (cCLP) as a biomarker of neutrophil-related inflammation, in autoimmune rheumatic disease (ARD) and non-ARD.

Conclusion
Our literature review supports a relevant role of cCLP as potential prognostic biomarker mirroring local or systemic inflammation, especially in chronic inflammatory rheumatic diseases.

https://www.sciencedirect.com/science/article/abs/pii/S1568997223000290

Styret reduseres med totalt 1 person. Tomas Kramar og Susanne Stuffers går ut. Inn kommer Kjersti Grimsrud.

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.

Håper vi kan se fin CC utvikling i Q1 som antydet (Kina tilbake + US satsing). Blir også spennende om Gentian har noen kort opp i ermet ifm CMD tidlig mai.
- GCAL utvikling / samarbeid
- CC potensial i US gitt nye helse instrukser der
- Hjerte markør utvikling / verifisering med lansering 2024
- Ny POC test offentliggjort og litt mer R&D pipeline info

Helt klart! Det har skjedd litt med kjøpsinteressen siden melding om CMD - noe neste topp20 vil vise ;)

Noe positive takter fra Q2-presentasjonen som økt bruk av Cystatin C, og fremgang for utviklingen av NT-proBNP.

Da er det også positivt at de fokuserer på pipeline utover intern R&D nå som denne er i hovedsak foruksert på NT-proBNP.

Expanding product portfolio with turbidimetric Retinol-Binding Protein (RBP) immunoassay

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic tests, is pleased to announce that its new CE-marked Gentian Retinol-Binding Protein Immunoassay is now available for sale. This diagnostic test is an insourced product from a reputable European supplier which has enabled Gentian to launch the product quickly and without significant R&D spend.

The assay is instrument independent and can be applied on a wide range of automated clinical chemistry analysers with a normal process time of less than 10 minutes.

The company sees an increasing demand for this assay, largely driven by an aging population and lifestyle associated diseases and deficiencies. Further, the company estimates the market for RBP to EUR 10-20 million. The initial market focus will be on Europe, followed by the US, both by pursuing established distribution channels, but also through new partners.

The Gentian RBP assay contributes to the diagnosis and monitoring of population wide diseases. RBP is a transport protein for retinol (vitamin A) in blood, synthesised in the liver and reabsorbed in the kidney. The diagnostic value is to be found in altered levels of circulating RBP in many conditions, including: vitamin A deficiency, undernutrition, renal dysfunction and diabetes.

The global increase of chronic diseases, such as diabetes and kidney disease as well as high prevalence of malnutrition, underlines the importance of analysing RBP to shed further light on these conditions. Studies show that RBP levels are elevated in patients with diabetes and renal dysfunction and reduced in conditions such as vitamin A deficiency and undernutrition [1,2]. Malnutrition presents a substantial socioeconomic challenge in today’s healthcare landscape, especially in long-term care facilities, where the prevalence has been reported to be as high as 85% [3].

Gentian Diagnostics’ CEO Dr. Hilja Ibert says: “Today’s launch of the Gentian Retinol-Binding Protein Immunoassay is part of our ambition to bring a steady stream of high-impact diagnostic tests to market, using our expertise in moving immunoassays from low-volume to high-volume clinical analysers”.


https://www.gentian.com/products/retinol-binding-protein-rbp

Gentian Diagnostics skal ha live presentasjon hos Investorweb i morgen!
Link: https://investorweb.no/ir-channel/GENT/event/02d9c2da-d8f5-4020-b27a-419c9fb6ddd3

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