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Flatlander
0
A little about ISO 13485:2016

lne-america.com/certification/iso-cer...

Note that ISO 13485:2016 expands the profile of companies and organizations to which the standard can apply: Organizations involved in one or several stages of a Medical Device Lifecycle or a Supplier or other External Parties providing such organizations with products for example.

Organizations involved in one or more stages of the medical device lifecyle Suppliers or External Parties who provide products to such Organizations
Design and Development
Production
Storage
Distribution
Installation
Servicing
...
Raw materials
Components
Sub-assemblies
Medical devices
Sterilization services
Calibration services
Distribution services
Maintenance services


In addition, the ISO 13485 standard requires that the organization identifies its role(s) in connection with the regulatory requirements (e.g. Manufacturer, Representative, Importer and / or Distributor), and determines the applicable regulatory requirements depending on the role(s), then integrates the regulatory requirements in the QMS.

A Quality Management System is neither meant to be a frozen in time nor is the company. The QMS is defined to help streamline and reinforce internal processes and procedures while carrying on with the changes and evolutions affecting the market.

How is ISO 13485 recognized worldwide?
ISO 13485 Standard pictoISO 13485 focuses on the harmonization of the Quality Management Systems in the framework of Medical Device regulatory requirements. It is not surprising to see that many jurisdictions recognize or even require that Medical Device manufacturers obtain ISO 13485 certification in order to access their market. A number of regulatory authorities have adopted the ISO 13485 certification standard as part of their own requirements to enable the sale of Medical Devices on their territory. The Medical Device Single Audit Program commonly referred to as MDSAP went a step further: it is built on the ISO 13485 principles and includes those principles as part of the audit criteria.

ISO 13485 and the Medical Device Single Audit program (MDSAP)
In the framework of the Medical Device Single Audit Program (MDSAP), organizations’ Quality Management System can be audited for potentially five different Medical Device markets. For companies selling or looking to expand their sales to one or to all of the countries involved in the MDSAP program (Australia, Brazil, Canada, USA, Japan), it is important to know that at a minimum, the requirements of ISO 13485 will be included in the auditing criteria along with only the applicable regulations of the authorities the company is concerned with.

From what I can see, there are several examples of EU marking of various medical devices preceding ISO 13485 certification. So I don't think the EU registration was waiting on this certification.

FL
Flatlander
0
Is it just me, or does the ImmunExpress Press Release seem to go out of its way not to mention Biocartis? My guess is that ImmunExpress (IE) carried just about all the water to provide quality control plans and documentation to win the approval.

BCART has a lot of irons in the fire and cannot afford to dedicate an undo amount of effort in supporting just one product. If this is the case, the good news is that their partner stepped up to pull the documentation together and respond to questions.

I may be reading between the lines too much but it is weird that the only mention of BCART is the license agreement between the companies.

FL
Tryck
0
quote:

Flatlander schreef op 27 februari 2020 14:50:


Tyrck

Youth, is the exception. I think in 10 years you will be happy that you speculated as you did. I have no fear of BCART failing technically. Theranos was smoke and mirrors, BCART is not. Every journal review of Idylla that I have read is positive.

My only concerns are political and business execution related. By political I mean protectionist policies and regulatory approval processes. I think the political risks are mitigated by having large partners. In my opinion, the chief business execution risks are selling too soon (Verrelst has said in interviews he would not pursue a sale) and the loss of key personnel. The shareholder base of BCART is so fragmented that it will be next to impossible to orchestrate a takeover that is not broadly supported. I owned GHDX before the EXAS acquisition. All it took was the Baker Brothers deciding it was a good time to sell and GHDX was gone as an independent company. The personnel issue happens whenever key people leave. It can affect the ability to meet deadlines.

Best wishes for your Investing Future!
FL


Thanks FL :)
I have time on my side so let's see where the wind will take us. Best of luck to you too.

FYI, for energy, renewable energy and recycling I have Vestas Wind, Elia, Neste Oy, Veolia & Sif Holding on my watchlist.
For 5G I think companies like NOK and ERIC can pose opportunities as well.
I'm looking to enter in some new positions as well but I think I will wait a few more days...
Jelle R
0
Jelle R
0
Nestel95
0
Is dit nu werkelijk door het virus?
Dit is toch wel een hele harde afslachting...

@FL thanks for you time in this forum. I read daily your comments. You make me very enthousiastic and i'm also 25 so have the time on my side. But sometimes it looks like you have only "good" news. So that scares me also + it's my first 'crisis'.

At the moment I try to keep calm. :D

Gl 2 everyone.

grtz
Nestel
joe123
0
We zitten in een zware overdrijvingsfaze.Dat er een algemene kleine correctie op komst was stond in de sterren geschreven.Bij Biocartis kan je van een fel overdreven crach spreken.Min 60 procent tegenover vorig jaar.Totaal onterecht in mijn ogen.
Super technologie,overal ter wereld meer verkopen,meer en meer deals met pharmabedrijven,uitbreiding van meerdere kankertest die in de pijplijn zitten.
Eens veranderd die kudde van koers en zal het vechten worden voor de aandelen van Biocartis.
En wie weet kan dat maandag al beginnen.
[verwijderd]
0
quote:

joe123 schreef op 28 februari 2020 11:38:


We zitten in een zware overdrijvingsfaze.Dat er een algemene kleine correctie op komst was stond in de sterren geschreven.Bij Biocartis kan je van een fel overdreven crach spreken.Min 60 procent tegenover vorig jaar.Totaal onterecht in mijn ogen.
Super technologie,overal ter wereld meer verkopen,meer en meer deals met pharmabedrijven,uitbreiding van meerdere kankertest die in de pijplijn zitten.
Eens veranderd die kudde van koers en zal het vechten worden voor de aandelen van Biocartis.
En wie weet kan dat maandag al beginnen.


Proficiat aan de kopers van vandaag, zij zijn de winnaars van morgen!

Reply
0
quote:

Laup 4 schreef op 28 februari 2020 11:40:


[...]

Proficiat aan de kopers van vandaag, zij zijn de winnaars van morgen!




Zolang het maar niet de verliezers van Maandag blijken te zijn.
Biocartis is deels afhankelijk van onderdelen levering vanuit China. Wat voor exacte invloed dit heeft horen we pas aanstaande donderdag 5 Maart.
Van een uitrol van het Idylla platform in China zal voorlopig ook geen sprake zijn en in Japan sluiten vanaf maandag ook lagere en middelbare scholen is ondertussen bekend gemaakt door de premier aldaar.
Het is helaas nog te vroeg om terug te juichen bij Biocartis.
Flatlander
0
Nestel

Most of my optimism is born out of the positive technical reviews of Idylla's ease of use, quick TAT and accuracy. I have said on occasion that history is littered with companies that had first mover advantage and a good product but failed to execute on the business side. You are right to push for balanced evaluation. I have cautioned that group think on discussion boards can be detrimental to your financial well being. Right now the biggest negative for BCART is the negative price momentum. But even in that there is a slight silver lining. During the past couple days the price action has been down hard on the open and middle of the day with a rally into the close. Usually, the smarter money tends to buy a close and not the open.

I have largely focused discussions on what I believe to be the largest impediment to BCART. The registration issue must be resolved to open the intended markets throughout the world. When this begins to occur with the FDA, Japan and China it will unlock the ability to finally compete in the intended POC market. I expect this to start occurring outside the EU this year.

I do have concerns about personnel. BCART is the kind of business that a few critical people can be very instrumental to achieving product-assay development and launches. I saw that Simone Marticke strategy adviser left BCART. She seemed impressive on a previous conference call. I can understand her reasoning for leaving. Getting paid to direct charitable fund distribution for the Gates Foundation would seem like an ideal job for a lot of people. BCART is continuing to roll out new products so the people that left do not appear to have had a detrimental effect. I do occasionally wonder if some of the delays in launches have been affected by some of the personnel changes.

For the most part BCART is now getting hit by outside concerns that are outside their control. I've been thru several periods like this, while it is gut wrenching, the companies I have invested in have come through similar crisis periods and have prospered. Given BCARTs product, the market size, stated strategy and the near term launches I'm very optimistic.

Regards

FL



[verwijderd]
0

Heb je die eindsprint weer gezien, van 4,88 naar 4,97 euro? Bijna 30.000 stuks op enkele minuten. Dat zijn shorters die graag uw goedkope aandelen overnemen. Nu verkopen? aan deze bodemprijzen? en met nog 3 beursdagen tot de cijfers en doelstellingen???

CGCDLR
0
Voila!bijgekocht(4,89).Biocartis is nu mijn grootste positie.Cijfers van donderdag moeten er bonk erop zijn,dat weet ik,dan nog hopen op een iets beter "beursklimaat"(?).Cash,zo'n 3€/a.Het resterende is maw. De waarde die de markt toekent aan bedrijf.Mijn inziens is dit een lachertje.
DRTVR
0
Ben nog te vlug geweest begin deze week, had beter gewacht dan was mijn gemiddelde beter, ik begrijp dat geshort niet, moet er me es in verdiepen, maar gokken op een dalende markt...
joe123
0
[quote alias=DRTVR id=12165986 date=202002282020]
Ben nog te vlug geweest begin deze week, had beter gewacht dan was mijn gemiddelde beter, ik begrijp dat geshort niet, moet er me es in verdiepen, maar gokken op een dalende markt...
[/quot
Zeker nu niet meer mee beginnen drtvr
Het is aan de longs nu.
DRTVR
0
quote:

joe123 schreef op 28 februari 2020 20:42:


[quote alias=DRTVR id=12165986 date=202002282020]
Ben nog te vlug geweest begin deze week, had beter gewacht dan was mijn gemiddelde beter, ik begrijp dat geshort niet, moet er me es in verdiepen, maar gokken op een dalende markt...
[/quot
Zeker nu niet meer mee beginnen drtvr
Het is aan de longs nu.



Was de bedoeling niet, alleen curieus omdat er hier regelmatig over gesproken werd, dacht zeker dat aan 5,4 bodem bereikt was, durfde niet meer wachten, maar verkeerd gedacht.
Hopelijk komt produktie niet in gedrang, en hebben ze genoeg voorraad om te kunnen blijven produceren.
Falcon16
0
Ik wacht toch nog even om me te versterken,ik denk dat het maandag in het algemeen een bloedrode dag zal worden op de beurs.
Flatlander
0
A little introspection.

As we are seeing, this week BCART is not the type of stock that works well in this environment. Even companies with solid and growing earnings that pay a dividend are getting hit hard. BCART requires the belief that the point of care MDx market will be the wave of the future. That is why I have underscored the efforts of the industry giants Illumina, Fisher and Roche to launch new products to try to gain entrance into the POC MDx market. I have excepted that I have mistimed my establishing a position in BCART, but I will not compound this mistake by selling when prices are just above cash on the balance sheet levels. I have rationalized that a sale at this time would be stupid since the company is at the cusp of regulatory approvals that would allow them to finally sell into the intended POC diagnostic MDx market rather than the RUO market. I believe that Idylla will gain major traction when the POC providers realize that not only can they provide accurate results much quicker with Idylla but they are likely to turn Idylla into a profit center of their practice. If Idylla assays are reimbursed by insurers at anything close to the CLIA labs or NGS testing there will be considerable margin for the POC provider to profit from Idylla assays run at their facility. While there may be Coronavirus related setbacks/delays discussed on Thursday, it is simply the wrong time to sell.

BCART is very likely a story for the next economic cycle assuming this downturn marks the end of a cycle. Unfortunately, that may mean that this virus initiates a global recession. BCART has the cash, products, partners, etc to make it through this cycle so they are better off than some their peers. The only thing they can control is their own execution, so I'll be listening for evidence that they continue to achieve milestones.

FL
Flatlander
1
This should be required reading for BCART Shareholders! I had a version of this post where I highlighted numerous sections. I took a break for breakfast and when I posted it it gave an error and I lost the post. So this is the short version.
FL

www.eacorp.com/wp-content/uploads/201...

Key take aways include that the cancer genomics part of MDx is likely to be the fastest growing subsector.

Testing is moving to the POC environment.

Costs are coming down in most areas but Table 3 suggest constant pricing the past couple years due to push back from NGS firms. The insurance reimbursement rates are still about 100% higher than BCARTS costs.

The entire conclusions section is a good summary of where things are headed.


Gijpie
0
Even though IVD manufacturer sales of FDA approved MDx tests for cancer are small today, this segment holds significant market potential because the clinical value of the tests is so high. For example, new companion diagnostic tests (CDx), which can command premium prices, are rapidly gaining adoption in clinical laboratories, a trend that is likely to continue given the numerous collaborations between pharma and diagnostic companies for CDx tests. Some of the key tests in this category include KRAS for colon cancer, EGFR for lung cancer, BRAF for melanoma and BCR-ABL for chronic myelogenous leukemia. Biocartis (Mechelen, Belgium) now offers a suite of these cancer tests on its sample-to-answer Idylla instrument platform.
As for major market growth drivers in cancer testing, EAC sees the following:
? Emergence of new CDx based cancer tests over the next 3-5 years.
? Expanded use of existing cancer biomarkers for additional cancers (e.g. HER-2 in stomach cancer).
? Growing use of liquid biopsy tests for diagnosis, monitoring response to treatment or recurrence of cancer (e.g. blood test for EGFR gene in lung cancer).
? Continued growth in the use of NGS technologies for tumor profiling,
Gijpie
0
Flat great article and yet again the small Mechelen based company is named in a mayor revieuw of the IVD market .
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