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DeZwarteRidder 26 april 2022 13:12

1

quote:
voda schreef op 21 april 2022 15:05:
Zo zo, de PB's misten hun doel niet! Wat een stijging zeg!

€ 2,515
+0,38
(+18,07%)

De nepstijging is weer foetsie en het was dus inderdaad een heel mooi verkoopmoment.

Tobiro 27 april 2022 21:12

0

Morgen verkoop ik ze met zware verliezen, maar ik zie geen licht aan het eind van deze tunnel.

Flatlander 29 april 2022 17:28

1

Sorry MB but I felt this article was worth sharing with the board.

emedicine.medscape.com/article/854424...

The Merlin assay on Idylla has a good chance of filling a critical need for dermatologists and oncologists, in that it will allow rapid assessment of the risk of skin melanoma's before they metastasize. BCART really needs to focus on products where the speed of results is a critical consideration. More importantly, they need to work with partners like Skyline that actually bear the cost of the IVD development and are very efficient in moving the product through the necessary development steps.

FL

MisterBlues 30 april 2022 10:20

0

quote:
Flatlander schreef op 29 april 2022 17:28:
Sorry MB but I felt this article was worth sharing with the board.

emedicine.medscape.com/article/854424...

The Merlin assay on Idylla has a good chance of filling a critical need for dermatologists and oncologists, in that it will allow rapid assessment of the risk of skin melanoma's before they metastasize. BCART really needs to focus on products where the speed of results is a critical consideration. More importantly, they need to work with partners like Skyline that actually bear the cost of the IVD development and are very efficient in moving the product through the necessary development steps.

FL

Je hebt gelijk. Ze hadden die focus op snelheid van resultaat van begin af aan moeten doen.

Flatlander 3 mei 2022 22:34

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Illumina Collaboration with JnJ announced at the CDx conference.
finance.yahoo.com/news/illumina-annou...
BCART has yet to demonstrate a successful CDx.

FL

voda 4 mei 2022 07:02

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PERSBERICHT: Persbericht Biocartis Group NV: Nieuwe studie geleid door Memorial Sloan Kettering Cancer Center (NY, VS) toont dat Idylla(TM) GeneFusion Assay snellere screening van gerichte genfusies toelaat in vergelijking met routinemethoden
PERSBERICHT: 4 mei 2022, 07:00 CEST

Nieuwe studie geleid door Memorial Sloan Kettering Cancer Center (NY, VS) toont dat Idylla(TM) GeneFusion Assay

snellere screening van gerichte genfusies toelaat in vergelijking met routinemethoden

-- Therapeutisch bruikbare genfusies zijn verantwoordelijk voor ongeveer 10%
van niet-kleincellige longkankers1

-- De huidige moleculaire methoden, waaronder Next Generation Sequencing
(NGS), zijn complex met een lange tijd-tot-resultaat

-- Studie2 toont aan dat de Idylla(TM) GeneFusion Assay (RUO3) een snellere
screening van gerichte genfusies mogelijk maakt in vergelijking met
routinemethoden
Mechelen, België, 4 mei 2022 -- Biocartis Group NV (de 'Vennootschap' of 'Biocartis'), een innovatief bedrijf in de moleculaire diagnostiek (Euronext Brussels: BCART), kondigt vandaag de publicatie aan van een nieuwe stud www.globenewswire.com/Tracker?data=-e... ie www.globenewswire.com/Tracker?data=O4... in het Journal of Molecular Diagnostics over de Idylla(TM) GeneFusion Assay www.globenewswire.com/Tracker?data=Qp... (RUO) voor snelle detectie van gerichte genfusies waaronder ALK, ROS1, RET en NTRK1/2/3 en MET exon 14 skipping mutaties. De studie concludeerde: "De test maakt een snelle screening mogelijk voor klinisch gerichte kinase alteraties met een snellere doorlooptijd en minder vereisten wat betreft het weefsel in vergelijking met immunohistochemie en moleculaire methoden, en omzeilt tevens de afhankelijkheid van infrastructuur die gepaard gaat met Next Generation Sequencing (NGS) en fluorescentie-in situ hybridisatie." De studie werd uitgevoerd door Memorial Sloan Kettering Cancer Center (NY, VS), een van de grootste private kankercentra ter wereld.

Herman Verrelst, Chief Executive Officer van Biocartis, gaf volgend commentaar: "Deze studie toont de toegevoegde waarde van de Idylla(TM) GeneFusion Assay wanneer snelle testing nodig is, en benadrukt andere voordelen van de Assay zoals de lage vereisten wat betreft het weefsel, waardoor verdere NGS testing in negatieve gevallen nog steeds mogelijk is, en - misschien wel het belangrijkste - met resultaten in drie uur tijd, dankzij de volledig geautomatiseerde aard van de Assay, terwijl andere methoden daar vandaag vaak meerdere dagen tot weken over doen."

Therapeutisch bruikbare genfusies zijn verantwoordelijk voor ongeveer 10% van de niet-kleincellige longkankers(1) (NSCLC). Tot 40% van de longkankers die door chromosomale herschikkingen worden veroorzaakt, worden in een gevorderd stadium (III tot IV)(4) gediagnosticeerd, terwijl tyrosinekinase-remmende therapie meestal leidt tot een snelle en diepgaande klinische verbetering(5) . Tijdige herkenning van deze alteraties is dus van cruciaal belang in de klinische setting. De huidige methoden om kinase genfusies te detecteren, zoals fluorescentie in situ hybridisatie (FISH) of NGS, kunnen complex zijn om uit te voeren, vereisen een aanzienlijke laboratoriuminfrastructuur, hebben lange doorlooptijden en interpretatie van de data kan omslachtig zijn. Hoewel NGS de standaard is geworden voor het zoeken naar therapeutische targets met hoge verwerkingscapaciteit, vereisen de meeste NGS-tests veel weefsel, hebben ze doorlooptijden van 2 tot 3 weken nodig en brengen ze onderliggende genomische en biologische complexiteiten met zich mee die kunnen leiden tot vals-negatieve genfusie resultaten.

De studie analyseerde 143 onafhankelijke FFPE(6) tumorstalen. De studie verklaarde dat "testing succesvol was in 142 (99%) gevallen". Verder dat "de Idylla(TM) GeneFusion Assay een gevoeligheid toonde van 97% (28/29), 100% (31/31), 92% (22/24), 81% (22/27) en 100% (20/20) voor ALK, RET, ROS1, en NTRK1/2/3 chromosomale herschikkingen en MET exon 14 skipping alteraties, respectievelijk, met 100% specificiteit voor allemaal".

De volledig geautomatiseerde Idylla(TM) GeneFusion Assay www.globenewswire.com/Tracker?data=Qp... (RUO) detecteert ALK, ROS1, RET, NTRK1/2/3 chromosomale herschikkingen en MET Exon 14 skipping in één enkele cartridge, met minder dan 2 minuten hands-on tijd en resultaten ter beschikking in ongeveer 180 minuten.

De CE-IVD versie van het Idylla(TM) GeneFusion Panel is gepland voor einde H1 2022.

--- EINDE ---

Moreandmore 4 mei 2022 09:11

1

Nieuwe studie positief over Idylla van Biocartis

ABM FN) Het Idylla-platform van Biocartis maakt met de GeneFusion Assay een snellere screening mogelijk van gerichte genfusies. Dit bleek volgens het diagnosticabedrijf uit een nieuwe studie door het Amerikaanse Memorial Sloan Kettering Cancer Center.

De test van Biocartis levert binnen drie uur resultaten op, terwijl andere methoden dagen of zelfs weken in beslag nemen.

“Deze studie toont de toegevoegde waarde van de Idylla GeneFusion Assay wanneer snelle testing nodig is, en benadrukt andere voordelen van de Assay zoals de lage vereisten wat betreft het weefsel”, aldus CEO Herman Verrelst in een toelichting.

Moreandmore 4 mei 2022 16:09

1

Biocartis publiceert nieuwe studie over Idylla GeneFusion Assay

Biocartis mag alweer een pluim op zijn hoed steken, dankzij de publicatie van een nieuwe studie in het Journal of Molecular Diagnostics. Daaruit bleek dat de Idylla GeneFusion Assay voor snelle detectie van gerichte genfusies waaronder ALK, ROS1, RET en NTRK1/2/3 en MET exon 14 skipping mutaties “een snelle screening mogelijk maakt voor klinisch gerichte kinase alteraties met een snellere doorlooptijd en minder vereisten wat betreft het weefsel in vergelijking andere methoden”. De studie werd uitgevoerd door het invloedrijke Memorial Sloan Kettering Cancer Center, een van de grootste private kankercentra ter wereld. Geen impact op 7 euro koersdoel en “Kopen”-advies.

de dromer 5 mei 2022 17:37

1

Ik heb een pakketje Biocartis gekocht. De reden is simpel: de verkoop komt op snelheid.
De enige zorg is de bijkomende financiering die nog nodig is. Dit zou geen probleem mogen vormen.
Het aandeel komt duidelijk op kruissnelheid. Bij koersdaling koop ik kleine pakketjes bij.

Flatlander 6 mei 2022 19:12

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Dreamer.

You are optimistic to wade in in this environment! I know you have to buy when there is blood in the street but I see a number of stocks selling for the amount of cash they hold. The market is just not ascribing any value to the stocks, the company's story or future potential. I'm encouraged that BCART is focusing on scaling the business. The market wants to see strong durable business models and good PRs will no longer cut it, unless they immediately lead to improved profitability.

BCART for the first time in my holding period seem to realize that the ATM just isn't open to raise funds.

Hopefully, you are benefited by an improving news flow.

FL

Flatlander 11 mei 2022 15:28

0

From the recent AMP Journal paper on the Idylla gene fusion panel:

"the Idylla GeneFusion Assay displayed a relatively high NTRK fusion detection efficiency. Combined with the fact that it is a completely automated system that provides results within 180 minutes and has a low failure rate even with older FFPE samples, it might be an asset in NTRK fusion testing algorithms. Similar to pan-TRK IHC, it can be used to screen for NTRK fusions with subsequent confirmation by another technology. While evaluation of pan-TRK IHC staining requires a specialized pathologist, the Idylla GeneFusion Assay is suitable for any lab. However, it should be noted that it might be necessary to tailor the Idylla GeneFusion Assay to cancer type."............

"Furthermore, the Idylla GeneFusion Assay has shown a clear potential in identifying NTRK fusions. Major advantages of this assay include the fact that is fully automated with a short turn-around-time as well as the robustness to process older FFPE samples. However, it might be necessary to interpret results obtained by the Idylla GeneFusion Assay per cancer type. Although RNA degradation and/or loss was observed in snap frozen tissue samples, this might be countered by increasing the amount of sample input."

These statements are both encouraging and discouraging at the same time. We are all aware of the advantages of Idylla but have seen that getting the method incorporated into any lab's testing algorithm or protocols can take years, if ever.

FL

Gemberthee 11 mei 2022 16:23

0

quote:
de dromer schreef op 5 mei 2022 17:37:
Ik heb een pakketje Biocartis gekocht. De reden is simpel: de verkoop komt op snelheid.
De enige zorg is de bijkomende financiering die nog nodig is. Dit zou geen probleem mogen vormen.
Het aandeel komt duidelijk op kruissnelheid. Bij koersdaling koop ik kleine pakketjes bij.

Ik wacht met opnieuw instappen als het aandeel onder de euro noteert.

de dromer 16 mei 2022 15:33

1

Bijgekocht en moesten ze dalen tot 1 euro dan koop ik weer bij.. Dezelfde manier pas ik toe bij
Unified Post en Mithra. Kleine pakketjes tot ik aan mijn gewenst totaal kom. Voldoende cash opzij
gezet om dit te realiseren.

Bonsjoer 17 mei 2022 18:07

0

twitter.com/Biocartis_/status/1526138...

Bonsjoer 17 mei 2022 20:34

1

LAUNCHING SOON!

The CE-IVD version of our fully automated, rapid and easy-to-use GeneFusion Panel on #Idylla™, generating results in approx. 180 minutes with less than 2 minutes hands-on time! ??

twitter.com/Biocartis_/status/1526138...

Flatlander 20 mei 2022 16:36

0

So what is going on with the FDA review of the Idylla MSI 510K? I can't understand why the delay (13 months and counting). Given the positives such as the following:

1)Abundant head to head performance comparisons published in refereed journals;
2)this is the 3rd or 4th application to FDA (JnJ lead RSV, ImmunExpress Septicyte, and I thought there might have been a Ebola EUA back in like 2015);
3)Professional regulatory staff was hired in the US to interface with FDA.

I have some concerns that Idylla is closely following last years Promega MSI approval.
Hope to hear something on this front soon.

FL

Bonsjoer 25 mei 2022 14:57

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SkylineDx announces Medicare coverage for its predictive melanoma assay MerlinTM Test

ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), May 25, 2022: Today, SkylineDx, a leading molecular diagnostics company, announces Medicare coverage for Merlin Test. The local coverage determination was issued under the foundational policy “Melanoma Risk Stratification Molecular Testing”, by the Medicare Administrative Contractor Palmetto GBA through its Molecular Diagnostic Service Program (MolDX) [2]. This coverage provides Medicare reimbursement for Merlin Test in cutaneous melanoma (skin cancer, thickness T1b-T2) patients for which additional guidance may augment and inform clinical management decisions by physicians considering the surgical Sentinel Lymph Node Biopsy (SLNB) procedure.

Merlin Test helps identify melanoma patients who are at low risk for nodal metastasis and may safely forgo SLNB surgery. SLNB is an invasive surgical procedure used to determine metastatic spread of the cancer for staging purposes. In approximately 80% of the surgeries, the biopsy comes back negative for metastasis and does not further impact the patient pathway. The test provides a more personalized insight on the metastatic propensity of the tumor; patients with a low-risk tumor could avoid the surgery [3].

“Medicare coverage for Merlin Test marks a significant achievement and is a critical step in helping melanoma patients gain access to this innovative molecular test, that on the basis of their personal risk profile, may directly impact and further improve their care”, comments Dharminder Chahal, CEO SkylineDx. “We commend MolDX for this acknowledgement in our efforts to personalize cancer care”.

About Merlin Test

Merlin Test uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes [3]. The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age; and has been analytically and clinically validated. Further clinical research and validation studies on the predictive use of the CP-GEP model is the main focus of Merlin Study Initiative, developed under the wings of Falcon R&D Program. More information (including references) may be obtained at www.falconprogram.com. Merlin Test is commercially available in the United States as a Laboratory Developed Test serviced from SkylineDx’s CAP/CLIA laboratory in San Diego (CA).

About SkylineDx

SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam (the Netherlands) and complemented with a commercial team, a field medical and scientific affairs team and a CAP/CLIA certified laboratory in San Diego (CA, USA). SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. To learn more about SkylineDx, please visit www.skylinedx.com.

Footnotes

Link to this press release on website SkylineDx (click here).
Foundational policy “Melanoma Risk Stratification Molecular Testing” (link to policy).
Bellomo et al., Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology (2020). doi.org/10.1200/PO.19.00206.

Image

Flatlander 26 mei 2022 14:23

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Bonsjoer

That is really huge news for Skyline since most private insurers will follow Medicare in short order. The coverage is a no brainer since it will save many times its cost in the avoidance of unnecessary lymph node biopsies. This is a killer application! The question for BCART is when will the IVD version can be rolled out on Idylla? Hopefully, the royalty is structured so that it and the lab version sales in the EU adds meaningfully to the bottom line,

FL

GoedeDag 26 mei 2022 18:32

0

quote:
Flatlander schreef op 20 mei 2022 16:36:
So what is going on with the FDA review of the Idylla MSI 510K? I can't understand why the delay (13 months and counting). Given the positives such as the following:

1)Abundant head to head performance comparisons published in refereed journals;
2)this is the 3rd or 4th application to FDA (JnJ lead RSV, ImmunExpress Septicyte, and I thought there might have been a Ebola EUA back in like 2015);
3)Professional regulatory staff was hired in the US to interface with FDA.

I have some concerns that Idylla is closely following last years Promega MSI approval.
Hope to hear something on this front soon.

FL

I sent a mail with your 3 points about the FDA review delay Flatlander.
Maybe they'll respond with something interesting.

Flatlander 27 mei 2022 15:12

0

quote:
GoedeDag schreef op 26 mei 2022 18:32:
[...]

I sent a mail with your 3 points about the FDA review delay Flatlander.
Maybe they'll respond with something interesting.

Renate really can't provide much of a public response since BCART needs to respect the confidentiality of the on-going negotiations,

My points as to why the process is taking longer than the typical 11 months is aimed at FDA, I think I previously shared the story of NVS's experience with seeking FDA approval for their diabetes drug Galvus years ago. The drug approval was being requested a few months after the approval of Merck/s drug Januvia. Despite great phase 3 study results in a huge test population (something on the order of 20,000) FDA issued a Complete Response Letter asking NVS to go back and evaluate why the preclinical animal studies resulted in a small percentage of monkeys developing a skin rash. This side effect was not observed during the phase 3 study in humans but it was simply a means to delay a new competitor from entering the US market. Galvus went on to gain approval throughout the industrialized world without additional studies on the pre clinical monkey skin rash. NVS withdrew the FDA application but went on to make Galvus a multi blockbuster in the rest of world market using the same data that was presented to FDA.

My read on this situation is that FDA acted politically to favor a domestic company, They put up a roadblock to delay a competitor to Merck. This happened during the George W Bush administration. But I have concerns that similar biases might still exist, My concern is that Idylla is following the new Promega assay pretty closely.

I hate to even suggest this but it is part of the reason that introducing a disruptive product may be harder than I originally thought. The US is likely not alone in this type of behavior, Note that the timeline for assay approvals in Japan and China have also been pushed back over the years.

Regards FL

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