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Flatlander 30 maart 2021 14:21

3

The following paper looks promising since it focuses on MDx in light of pandemic related disruptions to the lab system. I did not pay up for the full text, so I can't speak to the specifics.

www.sciencedirect.com/science/article...

FL

[verwijderd] 30 maart 2021 17:17

1

quote:
Flatlander schreef op 30 maart 2021 14:21:
The following paper looks promising since it focuses on MDx in light of pandemic related disruptions to the lab system. I did not pay up for the full text, so I can't speak to the specifics.

www.sciencedirect.com/science/article...

FL

Good news, I hope they make a press release out of it ! ;-)

[verwijderd] 30 maart 2021 22:53

2

quote:
Flatlander schreef op 30 maart 2021 14:21:
The following paper looks promising since it focuses on MDx in light of pandemic related disruptions to the lab system. I did not pay up for the full text, so I can't speak to the specifics.

www.sciencedirect.com/science/article...

FL

Here’s the Discussion:

Although NGS is the standard method in our lab whenever personalized mutation testing for cancer therapy is required, the COVID-19 pandemics hindered the routine usage of this technique in the last six months. Several delivery chain interruptions forced us to check alternative methods for initial therapy decision-making based on the mutational status of cancer patients whose number did not decrease during the time of the pandemics. An alternative method to rapidly test cancer patients that was not affected by delivery chain breaks was the IdyllaTM platform (6).

Our comparisons show that the cartridges have an acceptable overall performance and represent an excellent alternative for rapid therapy decision, which in nearly all cases would have been possible even in the absence of the NGS result. While NGS is more sensitive the clinical meaning of NGS is not always clear as it detects also minor cell populations in a tumor thus maybe leading to a moderate or minor improvement during subsequent therapy. Thus, in times when delivery chains are interrupted even in industrialized countries, Idylla TM can be a rapid an available alternative to maintain relevant diagnostics of diseases other than COVID-19.
A disadvantage, however, of IdyllaTM (Biocartis, Mechelen, Belgium) is that the console can only analyze a sample for one type of mutation at a time giving limited insight into the patient's tumor composition. If multiple mutations are to be tested then the corresponding cartridges will have to be present on hand. The tests can be run in parallel if multiple instruments are being used, or in sequence if only one instrument is available, however maybe creating a financial problem, as the multiple cartridges have to be on stock in concert with multiple instruments to run analyses in parallel. If however, an institute aims on fast and only partial results (as only specific mutations are relevant to determine the course of personalized treatment), IdyllaTM is the better choice as it gives the specific result in approximately 2 hours (7).
However, the specificity and the PPV of all the different mutation cartridges tested were all at 100%. For all the mutation types tested, if no mutation was present, IdyllaTM was capable of correctly recognizing this with a specificity of 100%. With a PPV of 100%, one can be certain that if the IdyllaTM test detects a mutation, that this mutation is in fact present.
Despite these advantages, the fact that some mutations are not fully resolved such as the BRAF 600 mutations, remains a limitation of the platform, as the correct molecular classification is crucial for the final therapy decisions, thus Idylla cannot replace the NGS but reduce the gap that results from delivery chain interruptions.

For EGFR the sensitivity lies at 93.3%, meaning 6.7% of the people tested with the EGFR mutation will not be detected. The NPV however, is much lower at 66%, as only two of the three samples detected negative for EGFR mutation were actually negative. The overall concordance between NGS and IdyllaTM for this mutation testing is 91.6%. Yet in another study, comparing Idylla EGFR results and NGS, the concordance is much higher at 97.59% testing 449 samples (8).
Using the NRAS-BRAF test, there was also a high concordance between all the samples. KRAS testing has the second highest sensitivity of the mutation types tested at 91%. The NPV is only 25%, which does not give an accurate depiction of the KRAS test, as the NPV would likely increase if a higher number of samples were tested.
A further bias of the Idylla system is the lack of a distinct differentiation between BRAF 600 mutations, which could be crucial for therapy decisions. This has to be taken into account and it has to be recommended to apply further analyses in BRAF 600 mutated cases identified by IdyllaTM. Discordant results observed here in our study were in the majority a result of a missing in depth differentiation in the IdyllaTM system, i.e. the mutations detected were at the correct locations identified by NGS but the particular nucleic acid and/or amino acids exchange was not determined by the IdyllaTM system. In case of BRAF mutations, the IdyllaTM system contains solely mutations at position 600, while NGS also detects mutations outside this region, although the clinical meaning of these mutations is minor. A further mutation at position 61 of KRAS specimen 8 was likely missed by IdyllaTM due to a lack of sensitivity, either because the tumor specimen on the FFPE block was not sufficient or did not contained mutated allelic variants above the IdyllaTM threshold, maybe because of tumor heterogeneity.
However, it is important to keep in mind that from a practical point of view the lack of more detailed information regarding the EGFR deletion mutations in the Idylla system would not have altered the therapy regimens, but from a pure scientific point of view must lead to the conclusion that the mutations were not determined fully correct. Anyway, as also in German round robin trials the Idylla method was accepted and the loss of detailed information on the mutations were not penalized as long as the correct treatment decision could be made, this fact was neglected in the subsequent calculation on sensitivity, specificity, and predictive values.

Flatlander 31 maart 2021 15:23

1

Pablo

Thanks for the expanded discussion. This sentence pretty much encapsulates the take away:

"Our comparisons show that the cartridges have an acceptable overall performance and represent an excellent alternative for rapid therapy decision, which in nearly all cases would have been possible even in the absence of the NGS result. "

We all know that there are some limitation and that Idylla is not the platform to explore all mutations. Rather BCART has focused on ones that are actionable (have readily available treatment). The article's point about needing multiple cartridges should bot be a deal breaker since the cartridges have a year shelf life and can be stockpiled and used later. I assume that the point about the BRAF 600 and the EGFR mutation sensitivity is probably the reason that BCART has indicated that revamped cartridges and/or combination cartridges are in the works for next year.

The concern here is the one that has always existed: in some cancers such as NSCLC there is often only a small amount of material available for testing. That is why the use of de-stained cytology smear samples may be important. Based on what I've read there continues to be a significant market for fast analysis of actionable targets but also for surveillance tracking of mutations during treatment.

So what did we learn 1) Idylla has a useful role coming out of the pandemic by providing rapid actionable results thus alleviating some of the lab testing burden, 2) there is a need to revamp some of the assays to improve specific mutation sensitivity. My hope is that the management team now has a couple years at the helm under their belt, so hopefully they can implement changes and improvements that allow Idylla to evolve quicker.

Thanks
FL

voda 1 april 2021 07:31

0

PERSBERICHT: Persbericht Biocartis Group NV: Biocartis kondigt publicatie van 2020 jaarverslag aan

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Biocartis NV
4,475 0,00 0,00 % Euronext Brussel

PERSBERICHT: GEREGLEMENTEERDE INFORMATIE

1 april 2021, 07:00 CEST

Biocartis kondigt publicatie van 2020 jaarverslag aan

Mechelen, België, 1 april 2021 -- Biocartis Group NV (de
'Vennootschap' of 'Biocartis'), een innovatief bedrijf in de moleculaire
diagnostiek (Euronext Brussels: BCART), kondigt vandaag de publicatie
van zijn 2020 jaarverslag aan. Het 2020 jaarverslag biedt een overzicht
van de cijfers en prestaties van Biocartis voor het boekjaar afgesloten
op 31 december 2020.

Het verslag is beschikbaar als PDF-bestand en kan vanaf nu
www.globenewswire.com/Tracker?data=nc...
hier worden gedownload vanop de website van de Vennootschap.

--- EINDE ---

Flatlander 1 april 2021 16:31

0

ImmunExpress and BCART should hear back from FDA soon on the December 2020 510K filing for Septicyte Repid.

www.meddeviceonline.com/doc/how-long-...,additional%20information%20(AI)%20requests.

FL

Flatlander 1 april 2021 16:41

0

I wish we did not have to wait for the Annual Report for Updates non the Geographic Rollout of Idylla.

"Distributor markets22 – In 2020, several countries that
are served through distributors were hit specifically
hard by the pandemic, often compounded by a
significant weakening of local currency versus the
Euro. As a result, declining volumes in amongst others
Latin-America, India, Pakistan and Turkey outweighed
continued growth in other parts of the world. New
market authorizations were obtained for the Idylla™
MSI Test in Colombia, Canada, Malaysia and Singapore,and for the Idylla™ EGFR Mutation Test in Argentina during H1 2020. End of October 2020, medical device registration
certificates were issued for the Idylla™ platform and the
Idylla™ EGFR Mutation Test by the Taiwan FDA. Post the
reporting period, in February 2021, the Idylla™ platform, the
Idylla™ BRAF Mutation Test (CE-IVD) and the Idylla™ EGFR
Mutation Test (CE-IVD) completed registration in Russia, as
such expanding the distribution network for Biocartis’ IVD
medical devices.
FL

Thole 2 april 2021 13:03

0

What is missing to me are some forward looking statements for 2021. Couldn't find any. When would these come? Or did I miss them completely?

[verwijderd] 2 april 2021 13:49

3

COVID-19 IMPACT EN 2021 VOORUITZICHTEN
Het jaar 2021 zal opnieuw in het teken staan van de aanhoudende gevolgen van de pandemie. Het zicht op de timing van normalisering van de wereldwijde kankerzorg is beperkt. Het is evengoed moeilijk om op betrouwbare wijze te voorspellen hoe de verdere behoefte aan SARS-CoV-2 testing zal evolueren naarmate de vaccinatie in de loop van het jaar in de verschillende landen in een verschillend tempo vordert. Met een breed Idylla™ testmenu in oncologie en een aantrekkelijk Idylla™ pandemie response menu gelooft Biocartis niettemin dat het zijn groei kan versnellen en volgende doelstellingen kan bereiken:

Commercieel cartridgevolume: Beoogde jaar-op-jaar groei van 40%-60% of commercieel cartridgevolume in de range van 320k-370k. Het plafond van de range zal enkel worden behaald ingeval van consistente sterke vraag naar de Idylla™ SARS-CoV-2 Test aan aantrekkelijke verkoopsprijzen doorheen 2021;
Installed base: Beoogde nieuwe Idylla™ instrument plaatsingen tussen 300-350;
Kaspositie: Beoogde kaspositie van tenminste EUR 50 miljoen op jaareinde, inclusief potentiële investeringen in het upgraden en uitbreiden van het infectieziekten testmenu.

Flatlander 2 april 2021 15:06

1

I've said this before but I'm pretty certain that BCART PR downplays information that might garner the attention of competitors (geographic information breakdown, anticipated IVD registration/launch dates, etc.). We all know this field is hyper competitive. The last thing BCART wants is for a bigger, better funded competitor to come in and try to sell the lab, hospital, university, clinic, etc on their alternative MDx platform right before a new Idylla launch,
For this reason I'm not dwelling on the financial metrics when most of the world is still in RUO authorization mode. That said the graph on pg 114 finally started to show some performance metrics starting to trend the right direction. The combination of the use registrations (MSI in the USA and Asian registrations) and the release of pent up oncology demand as the pandemic winds down could set the backdrop for a dynamic 2022.
FL

Thole 2 april 2021 17:40

0

Duidelijk dus over gelezen en/of gemist. Bedankt voor de info!

Flatlander 7 april 2021 01:08

0

A potential reason we are not hearing about the Idylla EUA approval from the FDA.
Other automated PCR tests (GeneExpert by Cepheid) are having difficulty detecting variants.
FL
www.medpagetoday.com/special-reports/...

ElTorro 8 april 2021 10:26

0

Other players using DNA-screening, interesting read

www.tijd.be/ondernemen/farma-biotech/...

[verwijderd] 9 april 2021 16:55

0

and again down down down :-(
What on earth could get some spark in this shareprice ...

Amsi 9 april 2021 17:15

0

Misschien een goedkeuring van FDA of een kapitaalinjectie van een Ursula krijgt ze ineens een zitje in de raad van bestuur.
Dan moet boer charel zijn gat nie heffen.

GoedeDag 10 april 2021 14:52

0

quote:
tomtesteron schreef op 9 april 2021 16:55:
and again down down down :-(
What on earth could get some spark in this shareprice ...

Overtreffende resultaten Q1 2021 rapport op 22 April

CGCDLR 10 april 2021 16:53

0

@ Goededag,het is maar de vraag of"overtreffende"resultaten er nog iets aan toe doet.Zo snel mogelijk zekerheid over de financiering van de komende jaren staat bij mij op 1 om de huidige manisch depressieve koersontwikkeling een halt toe te roepen.

Flatlander 10 april 2021 17:28

0

quote:
CGCDLR schreef op 10 april 2021 16:53:
@ Goededag,het is maar de vraag of"overtreffende"resultaten er nog iets aan toe doet.Zo snel mogelijk zekerheid over de financiering van de komende jaren staat bij mij op 1 om de huidige manisch depressieve koersontwikkeling een halt toe te roepen.

CGCDLR

You know my argument. It doesn't matter much until Idylla is allowed to be marketed for diagnostic use. But in markets where products already have IVD approval, the uptake is or will be driven by two things:

1) the buildout of the offerings menu. The more the machine can analyze the more the incentive to buy into the ecosystem;

2)Technical papers validating the product are in a sense a testimonial - this is a very strong mechanism for sales. This is especially true in cases where the papers identify or flow charts how Idylla can be incorporated into a labs day to day work flow to improve turnaround time, save money and/or make money for the lab.

As always, there are catalysts on the horizon but ultimately BCART will have to demonstrate that they are clearly on the road to profitability.

FL

Flatlander 10 april 2021 18:02

1

Novacyt (ALNOV.PA) got pounded down 38% yesterday, they loss a DHSC contract that accounted for 50% of sales. It is apparent that the contract loss was due to refusal to further negotiate a reduction in pricing for the government contract. This is why you hate to put in writing (as Novacyt did) that your products have an 80% margin.

I sold out of a portion of my position in the Fall, so that I recouped all my original investment and am playing with the houses money. That said. Novacyt should have around 200 million in the bank so the company itself is now being valued at bargain basement prices. I think the pandemic testing will persist for a couple years and Novacyt will find a market for their products in foreign markets and in the private sector. They are a leader in PCR analysis of variants. They are extremely quick to win new product approvals, so I think the market is now undervaluing the company and its IP.

Given what Hologic is spending for a Finnish PCR maker, I think it s worth acquiring shares of Novacyt again. However, this does point out an advantage to the BCART business model. Idylla sales are well diversified and are not concentrated in a single entity,

www.bizjournals.com/boston/news/2021/...

FL

CGCDLR 10 april 2021 18:15

0

FL,dank u wel,ik heb veel appreciate voor uw altijd heldere, positieve bijdrage.

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