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DeZwarteRidder
0
quote:

hastino schreef op 19 augustus 2020 18:12:


enkel een overname kan ons redden

Misschien krijg je wel 6 euro...........
Flatlander
0
COVID Depressed MDx testing

I've been trying to assess what to expect in terms of the first half earnings with the reported decrease in oncology biopsies due to COVID. The attached article suggests that testing procedures during the 2nd quarter have decreased markedly. The first half of 2019 was a weak period for BCART and the Fisher distribution relationship was terminated in September. Given these conditions the comparison basis is not especially high. Nevertheless, some decrease in revenue should probably be anticipated. NSTG which serves a similar market and saw a more than 25% decrease in total revenue during the 2nd Qtr. Given the weaker 2019 basis of comparison, and the relatively strong 1st quarter, I'm hopeful that they might show flatish or slightly positive revenue. If they can show continued growth in this environment, it would be a strong sign of market share gain.

BCART has a disruptive solution and technology but as we all know the roll-out and adoption have occurred at a slower rate than expected. I often ask myself, whether an industry can be disrupted when it is still in its relative infancy. Well, if there was ever a time when an industry was ripe for disruption, it is now in the midst of this pandemic. Turning results around quicker with less hands on time, with fewer steps and less rooms are all critical to maintaining social distancing in the lab. It will be interesting to hear whether Idylla is gaining traction in the past few months as patients are beginning to return to undergo screening and the labs are bogged down by COVID testing. Most importantly, news on the numerous registrations that will move Idylla from RUO to POC testing is what I'm anxiously listening for.

FL

www.oncnursingnews.com/web-exclusives...
joe123
0
De laatste keer dat Biocartis nog eens een PB de wereld instuurde is alweer van 26 juni geleden.
Die nieuwe cfo heeft nog niets van zich laten horen.
GoedeDag
0
Omdat er toch weinig nieuws is, kan er iemand die share premium is wat duidelijker uitleggen?

Heb het opgezocht en dan zouden er aandelen bijkomen maar hoger betaalt om ervoor te zorgen dat huidige aandelen niet in waarde verminderen.

Maar dan stond er nog dat er GEEN aandelen gingen bijkomen en die onmiddellijk werden gebruikt om de schulden uit de balans sheet te halen. Dit begrijp ik niet goed. Ook, wie gaat die premiums betalen?

Deze link,
www.investopedia.com/terms/s/sharepre...
, beschrijft het met een voorbeeld maar hierin komen er telkens wel aandelen bij.
joe123
0
3september resultaten 2 de kwartaal/halfjaar.
Biocartis probeer ons eens op een positieve manier te verrassen.
Flatlander
1
Idylla passed the QA portion of the China registration. Looks like China registration for EGFR, KRAS & BRAF are getting close or possibly are approved already. This would include the vast majority of the country. I wish the site would allow cutting and pasting the relevant portions. I do not know the Chinese registration process other than what I can glean from the internet (see below). I'm sure we will hear more about this in a couple weeks in the 1st half review.

www.wondfocartis.com/news/aid/73/cid/...

Here is a brief discussion of portions of the Chinese registration process. Use the link because there is a discussion of the reimbursement program that is too long to attach.

FL
"Generally, all Class II and III IVDs need to go through local clinical studies in China if they are not on the exempt list. For imported IVDs, testing requirements are the same as for medical devices. The CFDA’s testing centers will follow specification and testing methods in the product technical specification file, as drafted by the foreign company. Class III IVDs must go through a multicenter study with at least three clinical sites. There must be a minimum of 1,000 samples, including positive and negative. The IVD study should be a comparison study, based on the method that is considered the gold standard. If no similar IVD product exists, other kinds of recognized clinical diagnosis criteria, such as CT or MRI results, can be used to meet the comparison standard.

Clinical trial approval is not necessary for an IVD registration clinical trial. However, the ethical committee (EC) of the clinical sites (hospitals) must review the study protocol. After review, the hospital will issue an EC exemption or approval letter. That letter must be submitted as part of the clinical data after the trial is completed, and as part of the product registration filing with the CFDA.
While all Class II and III IVDs have been required to go through local clinical studies in China, China’s State Council recently issued new regulations on October 8, 2017 that should allow some foreign clinical trial data for medical device and IVD registration. Trials must be conducted at multiple centers and meet CFDA registration requirements. These changes should be positive for Western medical device manufacturers, reducing the need for local clinical trials, lowering market entry costs, and cutting the time needed to achieve registration. Avoiding the need for a local clinical trial could reduce the IVD registration timetable by about one year. What remains unclear is which IVD products will be able to use data from foreign clinical trial data."

www.medtechintelligence.com/feature_a...
Flatlander
1
www.medtechintelligence.com/feature_a...

Here is the reimbursement discussion. I'm glad BCART is partnered with Wondfo since they are a recognized leader in the POC market in China. Unfortunately, it looks like a 2 year period is necessary before the IVD is eligible for reimbursement. But at this point just having access to the POC (rather than just RUO) market would be huge.

Reimbursement of IVD Products in China
IVD reimbursement is performed entirely at the provincial level; the national government does not influence the provincial reimbursement process in any way. All Chinese provinces have three bureaus that are independent but interact with one another on reimbursement: a pricing bureau, a health insurance bureau and a bureau of health. Each province has a different code for a given IVD. In setting the price, the role of the pricing bureaus is to check factors such as how essential the test is, how the test is superior to others, reagent costs, equipment depreciation, test costs, and so on. The bureau will also seek feedback from key opinion leaders. The reimbursement processes amongst the provinces are similar, but can result in different reimbursement amounts.

In general, the reimbursement process works as follows. If, for example, a hospital wants to buy a new test from a Chinese distributor that costs $250 per test, the pricing bureau may set a price of $350 per test. When a patient at the hospital takes the test, they would show their insurance card and not have to pay. The hospital would then be reimbursed $350 by the provincial insurance division. The $100 difference is taken by the hospital as profit, although the real profit will be reduced by the hospital’s expenses.

Usually, a new IVD product will be eligible for reimbursement after it has been sold for two years. During that two-year period, the IVD is entirely self-pay. After those two years, it normally takes six months to obtain a new IVD reimbursement rate. Reimbursement may not be difficult if the new IVD’s price is not too high and is superior to an existing IVD that already has a reimbursement price. It may be more difficult to obtain reimbursement if the IVD is high priced. It remains unclear if a clinically better IVD will be accepted at a higher price.

Tenders are generally issued once a year, although this has become less predictable in many provinces. Local distributors are the agents that help manufacturers navigate the bidding process. Provincial regulators will take a minimum of three months to publicly announce bid winners.
If the manufacturer loses a bid, it cannot enter hospitals in that province. The procurement price (purchase price by hospitals) in each province is specified in the accepted bid. If a foreign IVD manufacturer wins the bid but the asking price is too low, the manufacturer may reject the bid and give up the market in that province. It is important to note that winning the provincial bidding process does not guarantee entry into specific hospitals. Manufacturers must also individually pursue listing privileges with each hospital in the province.

As China’s population continues to age and grow wealthier, the demand for high quality, easy to use IVDs will only increase, making it an attractive market for foreign IVD manufacturers. The exceptionally complex and constantly changing regulatory and reimbursement environment means that manufacturers must proceed with caution. They should realistically assess the likelihoods of obtaining registration approval and an advantageous reimbursement rate for their products to ensure their best chances of success.
Flatlander
0
There are a lot of take aways. China is a huge IVD market and projected to grow appreciably.. The two links together show BCART is getting close to unlocking POC testing in the largest market in the world. The other link explains the process for registration approval and reimbursement. I do not want to bias the take away by putting my spin on the relevant points.

In a little over a week we should get an update that will flesh out both the Sepsis triage and the China registration status.

FL
brightlight
0
FL
your post on China is very encouraging. The bit from the press release that I find particularly interesting is the following:

"Recently, the National Health Commission's Clinical Laboratory (NCCL) announced the results of the first inter-laboratory quality assessment of EGFR, KRAS, BRAF and other gene mutation tests in 2020. As a rising star in the industry, Wanfu Cartis has registered for EGFR, KRAS, Three BRAF projects, using Idylla™ products, all passed with full marks. This is the first time that Idylla™ has participated in the domestic external quality assessment. All three projects passed full marks, proving that Idylla™ is suitable for domestic EGFR, KRAS, BRAF mutation detection. These three projects cover more than 30 provinces (municipalities, autonomous regions) across the country, of which more than 400 laboratories participated in EGFR alone, which are widely representative."

I wonder if 400 labs participated, does that then also mean 400 consoles were sold??? If so it would mean a major boost to the installed base.
BL
CGCDLR
0
Stel wanneer ,er zoveel consoles geplaatst zijn& de septic rapid test nu al gebruikt wordt, moet dit dan niet gecommuniceerd worden naar de aandeelhouders (gevoelige informatie)?
Flatlander
0
quote:

CGCDLR schreef op 25 augustus 2020 11:47:


Stel wanneer ,er zoveel consoles geplaatst zijn& de septic rapid test nu al gebruikt wordt, moet dit dan niet gecommuniceerd worden naar de aandeelhouders (gevoelige informatie)?


BL
I had that same thought. However, Idylla has been approved for RUO for quite a while, so we do not know when the consoles were placed.

The key wording is that they applied for registration of the three assays. Why do you think MSI was not included? I'm guessing it has been held up for the BMY CDx demonstration.

The other article suggests that the process has been streamlined enough to shave a year off of the registration approval. I have to be frank that I read it about three times to convince myself that the "inter room quality evaluation" was part of the registration approval. I find the Chinese PR statements a little confusing at times.
.
FL
brightlight
0
quote:

CGCDLR schreef op 25 augustus 2020 11:47:


Stel wanneer ,er zoveel consoles geplaatst zijn& de septic rapid test nu al gebruikt wordt, moet dit dan niet gecommuniceerd worden naar de aandeelhouders (gevoelige informatie)?

Septicyte Rapid werd in Europa goedgekeurd op 26 maart 2020 en de verkoop daarvan is normaliter volop aan de gang. Voor de U.S. is het nog steeds wachten op de goedkeuring, normaal dit kwartaal. Voor China staat het nog niet op het programma.
Bcart hanteert een PR stilte periode van 1 maand voor de halfjaar en kwartaal resultaten. Ik denk niet dat dit geldt voor bepaalde koersgevoelige info, maar het aantal verkochte consoles valt daar zeker niet onder. Volgende week zal wel heel wat nieuws te rapen vallen over de vooruitgang op alle domeinen. Er komt ook (zoals gebruikelijk) een update van de corporate presentation. Ik ben erg benieuwd.
brightlight
0
FL
I have no idea why the MSI test was not included in the China inter lab quality assessment. Maybe because MSI falls under a different category of gene mutation tests that were not included in the inter lab study. Who knows?
Concerning the 400 consoles. Indeed some of them may have been placed in 2019, but considering that the total number of consoles newly installed for the whole of last year was only 337, I cannot imagine that the China number was very high. Besides I cannot recall that China was ever mentioned as a large contributor to sales last year. In Q1 of this year 40% of console sales came from the U.S. No mention of China either. This gives us two options. Either the China press release gives us the wrong impression, or the bulk of the 400 consoles was placed in Q2'20, which doesn't seem realistic because surely the inter-lab study has started way earlier?
Still the press release seems quite specific:
"All three (Wanfu Cartis) projects passed full marks, ... . These three projects cover more than 30 provinces (municipalities, autonomous regions) across the country, of which more than 400 laboratories participated in EGFR alone, ... ."
Another enigma to add to the list.
BL
joe123
0
Wie weet kan Biocartis ook een deal met China a la IBA aankondigen volgende week donderdag?
IBA plus 23 procent momenteel.Hoe hoopvol zou het zijn om zulk een PB eens de wereld in te sturen.
Flatlander
0
quote:

brightlight schreef op 26 augustus 2020 10:06:


FL
I have no idea why the MSI test was not included in the China inter lab quality assessment. Maybe because MSI falls under a different category of gene mutation tests that were not included in the inter lab study. Who knows?
Concerning the 400 consoles. Indeed some of them may have been placed in 2019, but considering that the total number of consoles newly installed for the whole of last year was only 337, I cannot imagine that the China number was very high. Besides I cannot recall that China was ever mentioned as a large contributor to sales last year. In Q1 of this year 40% of console sales came from the U.S. No mention of China either. This gives us two options. Either the China press release gives us the wrong impression, or the bulk of the 400 consoles was placed in Q2'20, which doesn't seem realistic because surely the inter-lab study has started way earlier?
Still the press release seems quite specific:
"All three (Wanfu Cartis) projects passed full marks, ... . These three projects cover more than 30 provinces (municipalities, autonomous regions) across the country, of which more than 400 laboratories participated in EGFR alone, ... ."
Another enigma to add to the list.
BL



BL
You can drive a truck through the ambiguities in the Chinese PR statements. I don't believe it states that Idylla was run at all 400 labs participating in the EGFR QA testing program. Maybe some ran only their primary method (NGS etc.). Either way China has incentives not to slow walk the registration approvals.

It is interesting to note that the Cepheid has stated in the past that the cartridge based sample to an platform is a good fit for many emerging markets (see link). China has a huge smoking population and EGFR mutations are present in 40% of NSCLC cases there. It seems like Idylla could be a very good fit for that market. I also think EXAS desire to crack the China market will drive the launch of OncoType Dx Breast assay.

Look at the Chinese 2yr reimbursement criteria and the emphasis on accuracy and costs. As we have previously discussed, Idylla is able to price considerably lower than NGS methods. This should be a decided advantage in winning the reimbursement. We are in the earliest innings of this game. If Cepheid has penetrated only 20% of smaller hospitals in the US 8-10 years after launching Gene Expert it tells you the adoption rates are slow and steady, but it will play out over decades.

Hopefully. the 1st half call and the market update shine a light on this opportunity.
FL


www.benzinga.com/analyst-ratings/anal...
brightlight
0
FL
Concerning China, what is the use of a press release when it is full of ambiguities? Still, we should see an update on the progress in China at the H1'20 earnings call, I suspect. It surprises me that Bcart didn't put out a press release themselves on the China EGFR testing program, but probably that has to do with the silent period. We will know more in a couple of days. Wait and see. Hopefully there is a positive surprise for a change, in whatever shape or form.
BL
voda
0
PERSBERICHT: BIOCARTIS KONDIGT 2020 HALFJAARRESULTATEN AAN OP 3 SEPTEMBER 2020

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Biocartis NV
4,745 0,00 0,00 % Euronext Brussel

PERSBERICHT: GEREGLEMENTEERDE INFORMATIE

27 augustus 2020, 07:00 CEST

BIOCARTIS KONDIGT 2020 HALFJAARRESULTATEN AAN OP 3 SEPTEMBER 2020

Mechelen, België, 27 augustus 2020 -- Biocartis Group NV (de
'Vennootschap' of 'Biocartis'), een innovatief bedrijf in de moleculaire
diagnostiek (Euronext Brussels: BCART), kondigt vandaag aan dat het zijn
2020 halfjaarresultaten en vooruitzichten voor de rest van het jaar zal
bekendmaken op 3 september 2020 om 07:00 CEST.

Het management team van Biocartis zal op de dag van de aankondiging van
de resultaten een conference call met live webcastpresentatie houden, op
3 september 2020 om 15:00u CEST / 14:00u BST (UK) / 09:00u EDT (VS).


-- Voor toegang tot deze live webcast, klik
edge.media-server.com/mmc/p/wd8xqtyo hier.

-- Om deel te nemen aan de vraag- en antwoordsessie, gelieve 5-10 minuten
vóór de start in te bellen op een van de onderstaande nummers,
gevolgd door de bevestigingscode 6661855.

-- Inbelnummers:

-- België, Brussel ...........................
+32 (0)24009874

-- Frankrijk, Parijs ..........................
+33 (0)176700794

-- Nederland, Amsterdam ................ +31
(0)207143545

-- Verenigd Koninkrijk, Londen.......... +44
(0)8445718892

-- Verenigde Staten, New York..........
+16315107495

De conference call en webcast zullen in het Engels gevoerd worden. Kort
nadien kan de webcast op de
www.globenewswire.com/Tracker?data=kG...
Biocartis
www.globenewswire.com/Tracker?data=df...
investeerderswebsite herbeluisterd worden.

--- EINDE ---

Meer informatie:

Renate Degrave

Hoofd Corporate Communications & Investor Relations

e-mail
www.globenewswire.com/Tracker?data=Ie...
rdegrave@biocartis.com

tel +32 15 631 729

gsm +32 471 53 60 64
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