Eurobench.com

[verwijderd] 6 oktober 2020 10:48

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quote:
MisterBlues schreef op 6 oktober 2020 10:37:
[...]

Boost!? Een tijdje terug stond BCART nog op 5. 2 jaar terug op 10.

Het is pas als de jaar en kwartaalcijfers erop duiden dat de groeiversnelling terug is dat de koers weer ECHT omhoog kan. Tot die tijd blijft er een diep wantrouwen bij de markt bestaan of BCART zijn aspiraties kan waarmaken qua cartridge verkoop.

Daarvoor heb je echt meer nodig dan wat gedeelde succesjes met andere bedrijven.

EXAS heeft nu het superieure platform voor vloeibare stalen kankermutatietesten. Illumina en Fisher timmeren vrolijk verder met NGS en moduleren ervan, en dus het goedkoper en toegankelijker maken van deze methodes.

Waar blijven de innovaties van BCART zelf?

Volledig mee eens. Er moet echt wel wat groters uit de bus komen wil ik mijn positie ooit uitbreiden.

[verwijderd] 6 oktober 2020 12:39

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quote:
tomtesteron schreef op 6 oktober 2020 09:22:
Ben vooral eens benieuwd wanneer de covid-19 test goedkeuring krijgt. Dit zou niet meer te lang mogen duren en kan een tweede boost aan de koers geven.

Nog negerns gevonden wat de prijs is van een toestel met dan 2 cartridges (1 covid-19 en 1 septicyti).

en dan de test plaatsen in de inkom, een uur wachten en dan verder of afzonderen. :)

kan het korter en beter ???
en zekerder ???

Amsi 6 oktober 2020 19:14

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Weinig enthousiasme precies, vind dit toch gezien de omstandigheden een mooie trigger.
Biocartis wordt zo weer in de kijker gezet, hopelijk volgt snel goedkeuring covid-test maar zijn er veel die wachten op deze goedkeuring.
Niet onlogisch met galapagos en nu ook mitrha in het achterhoofd.

[verwijderd] 6 oktober 2020 20:51

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quote:
Amsi schreef op 6 oktober 2020 19:14:
Weinig enthousiasme precies, vind dit toch gezien de omstandigheden een mooie trigger.
Biocartis wordt zo weer in de kijker gezet, hopelijk volgt snel goedkeuring covid-test maar zijn er veel die wachten op deze goedkeuring.
Niet onlogisch met galapagos en nu ook mitrha in het achterhoofd.

Helemaal waar Amsi.

Phoene 7 oktober 2020 00:36

1

Verwachten jullie dan zoveel van de Covid test? Er zijn toch andere goedkopere en snellere tests beschikbaar die in een groter volume kunnen uitgevoerd worden? Vooral het test volume lijkt me een beperking met slechts 7 tests per toestel.

Amsi 7 oktober 2020 08:36

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Nee, verwacht niet dat dit veel gaat te weeg brengen enkel wel een mooi bewijs waartoe men bij biocartis toe in staat is.
Heb al eerder aangehaald dat ik liever vooruitgang zie op hun core business.
Na gisteren kun je enkel concluderen dat dit als een zwaard van damocles boven de markt hangt.

DRTVR 7 oktober 2020 11:25

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Heb toch de indruk dat het nieuws van de laatste dagen... als positief ervaren word, houden en zo verder omhoog zou ik zeggen.

brightlight 7 oktober 2020 12:43

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quote:
Phoene schreef op 7 oktober 2020 00:36:
Verwachten jullie dan zoveel van de Covid test? Er zijn toch andere goedkopere en snellere tests beschikbaar die in een groter volume kunnen uitgevoerd worden? Vooral het test volume lijkt me een beperking met slechts 7 tests per toestel.

Bcart verwacht voor de 2e helft van het jaar een stijging van het aantal verkochte cartridges met ong. 43% t.o.v. 2e helft van vorig jaar (hun guidance van 148.000 tests oftewel FY(228.000) min H1(80.000)). Op de conference call wist Verrelst te vertellen dat men verwacht de oorspronkelijke jaardoelstellingen ondanks corona toch nog te halen dankzij de Septicyte Rapid en de Covid test, m.a.w. hetgeen men verloren heeft in de eerste jaarhelft aan cartridge sales verwacht men in H2 o.a. goed te maken met de nieuwe tests. Je zou verwachten dat het toch wel gaat om zo'n 15 tot 25.000 tests.

[verwijderd] 7 oktober 2020 13:46

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Het heeft zich toch in een degelijk volume vertaald de afgelopen 3 dagen.
Iets wat lang uitgebleven is.

Flatlander 8 oktober 2020 00:24

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quote:
MisterBlues schreef op 6 oktober 2020 10:37:
[...]

Boost!? Een tijdje terug stond BCART nog op 5. 2 jaar terug op 10.

Het is pas als de jaar en kwartaalcijfers erop duiden dat de groeiversnelling terug is dat de koers weer ECHT omhoog kan. Tot die tijd blijft er een diep wantrouwen bij de markt bestaan of BCART zijn aspiraties kan waarmaken qua cartridge verkoop.

Daarvoor heb je echt meer nodig dan wat gedeelde succesjes met andere bedrijven.

EXAS heeft nu het superieure platform voor vloeibare stalen kankermutatietesten. Illumina en Fisher timmeren vrolijk verder met NGS en moduleren ervan, en dus het goedkoper en toegankelijker maken van deze methodes.

Waar blijven de innovaties van BCART zelf?

Hey MB

New innovations are always welcome. However what is urgently needed is execution on existing programs and investments. When I first invested in BCART, one of my flawed assumptions was that the FDA 510K approval of the RSV cartridge would bring familiarity with the platform that would help with subsequent registrations. This has not occurred. As I mentioned a few weeks ago, we have yet to see one one of the announced partnerships translate into significant sales. Hopefully Septicyte Rapid/Immunexpress is the start of these partnerships paying off. Part of my rationale was that BCART could leverage Amgen, AZN, BMS, Gilead sales teams to ramp sales of Idylla CDx products. To date this has not happened. I realize now that I over estimated .how quick cancer MDx would move to the POC environment. The diaceutics webinar has suggested that the COVID pandemic is likely accelerating the move to decentralized cancer MDx. This trend should benefit BCART. So I'm resigned to another year of watch and wait.

www.diaceutics.com/316ab81f-0716-4040...

I don't know that innovations are necessary. Several papers have shown a synergistic model for Idylla use combined with NGS. They have flow charted the work flow. The problem is the system is still not approved in most markets for diagnostic use.

I've secretly hoped Novacyt would move to buy BCART. They are the polar opposite and are quick to introduce new products to the market. I think their Primer Design Group could expedite the IVD registrations. They would benefit from a POC platform (a MDx trend that analyst say is on the horizon) that they could more quickly launch content on Idylla than BCART is able to launch. While they are still small, they are minting cash so they could afford the acquisition.

Regards
FL
.

brightlight 8 oktober 2020 12:06

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quote:
Flatlander schreef op 8 oktober 2020 00:24:
[...]

Hey MB

... The problem is the system is still not approved in most markets for diagnostic use.

I've secretly hoped Novacyt would move to buy BCART. They are the polar opposite and are quick to introduce new products to the market. I think their Primer Design Group could expedite the IVD registrations. They would benefit from a POC platform (a MDx trend that analyst say is on the horizon) that they could more quickly launch content on Idylla than BCART is able to launch. While they are still small, they are minting cash so they could afford the acquisition.

Regards
FL
.

FL,

I don't think Novacyt has enough cash to buy Bcart (yet :)).

Concerning a fully approved Bcart test for the U.S. market I am anxiously awaiting the combined approval of Septicyte Rapid and the Covid test. According to the global sepsis alliance and a bioMerieux publication: "Many patients affected by COVID-19 will die from sepsis and its complications. It is therefore vital to know and recognize early signs of sepsis, and initiate prompt treatment when diagnosed. In the U.S., one in three patients who die in a hospital die of sepsis. Two published case series about patients with severe COVID-19 from the Seattle, WA, area reported septic shock severe enough to require drugs to support the heart and circulation in almost 70% of patients. The overall organ damage among these patients was also substantial. More than 30% of patients in one series had evidence of liver injury and 75% had evidence of a depressed immune response. The other series reported acute kidney failure in almost 20% of affected patients requiring ICU care. In these studies, the great majority of patients tested negative for co-infection of bacteria and viruses. The lack of bacterial or viral co-infection suggests that the observed septic shock and/or organ damage may have been directly related to SARS-CoV-2.

While viral sepsis is a possible complication of SARS-CoV-2, viral infections alone generally do not cause sepsis as frequently as bacterial infections do. For example, seasonal influenza is commonly associated with bacterial co-infection that leads to severe illness. It is typically this kind of severe illness that requires admission to the ICU and causes ventilator-associated pneumonia. Often times, flu-associated bacterial co-infection is caused by pathogens that colonize in the nasopharynx—the upper part of the throat that sits behind the nose. Common bacterial pathogens that lead to pneumonia and sepsis include staphylococcus and streptococcus. From the case series previously discussed, COVID-19 may differ from seasonal influenza, causing sepsis more often by itself, rather than from a bacterial co-infection.

However, other data suggest that co-infection with COVID-19 may be more common. A study published in April 2020 investigated the co-infection rates between SARS-CoV-2 and other respiratory pathogens and found that more than 20% of positive SARS-CoV-2 specimens also tested positive for one or more non-SARS-CoV-2 pathogens. These specimens came from symptomatic patients, with symptoms ranging in severity. A retrospective study of hospitalized COVID-19 patients found an even greater likelihood of co-infection. The study showed that, of patients who did not survive, half had experienced a secondary infection. Of the non-survivors, 100% of patients had sepsis and 70% were noted to have septic shock."

Conclusion: I would say it is of the utmost urgency that the FDA approves the test in order to be able to diagnose early and avoid more Covid-19 related deaths. When approved, the Septicyte/Covid test would be the first 'fully approved in the U.S.' (!) Bcart test we have all been waiting for for so long. It seems to me the imminent approval (expected between now and no later than November 10) will be greeted by the market rather favourably.

BL

[verwijderd] 8 oktober 2020 13:50

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De EERSTE volledig goedgekeurde Bcart-test in de VS.Stel je voor.En dit kan dan binnen enkele dagen en weken uit de bus vallen.Als er dan geen koersexplotie van komt weet ik het ook niet meer.Dan gaan we binnen de korste keren naar 10 euro.Nog even met veel spanning afwachten natuurlijk.

Flatlander 8 oktober 2020 15:36

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BL

I agree Novacyt could not buy w cash right now. They could structure a deal with cash and stock. I had an email exchange w Jane Papadaki from Immunexpress. We discussed the limited Septicyte Rapid (SR)results for Covid patient data that introduced at the SCCM conference a few weeks ago. There certainly is a tremendous potential and need for SR. But the study is complex. Sepsis is diagnosed based on a combination of non-unique indicators. The SOFA score is not an ideal basis for conducting the study since it may vary from one medical care provider to another. The second big problem is that Immune express does not appear to have full access to patient medical records. Their study attempted to relate the Septiscore to intubations/placed on ventilator. These may not equate to sepsis, so the study is complicated. People can go on a ventilator for bad pneumonia, complications from COPD, etc. Given these limitations, it appears that much of the analysis is conducted "in silico" or by computer modeling. Unfortunately, the best indicator of SR reliability would be patients that score high and die. This is a horrible outcome that hopefully SR can reduce. I hope they are able to quickly resolve the false negative and false positive issue and complete the validation quickly.

I said it before, septicyte rapid could be a Killer Ap for BCART. Another potentially exciting development is that Immunexpress and Novacyt are apparently working on a next generation sepsis diagnostic. The relationship partnership was renewed and I expect a product to come out of the collaboration in the next year or so. Obviously, this would be an application best suited for the POC environment. So potentially, I can see an important roll for BCART in the future.

FL

CGCDLR 8 oktober 2020 17:51

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Eerste volledig goed gekeurde test in VS zal traditiegetrouw gevolg worden door een KO.Zo hebben ze het ons de voorbije jaren gewoon gemaakt!Bij voorkeur een operatie waarbij de kleine beleggers geschoren worden.Meteen ook de reden waarom de koers blijft hangen.

Stockbrood 8 oktober 2020 19:29

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Citadel europe heeft op 6/10 zijn shortpositie afgebouwd van 2.39% naar 2.27%.

Bron: www.shortsell.nl

Flatlander 8 oktober 2020 21:13

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This looks like an interesting webinar invitation that was emailed to me.

Date: November 10, 2020
Time: 8:00 am PDT / 11:00 am EDT

The COVID-19 pandemic created a paradigm shift in modern healthcare, where regulations, protocols, and mindsets had to be reworked in just a matter of months to keep up with the pace of the virus. In particular, the in vitro diagnostic (IVD) market experienced a dynamic never seen before: SARS-CoV-2 tests were developed at a record-breaking pace amid global supply shortages as labs struggled to keep up with unprecedented demand.
REGISTER HERE

Although the pandemic is far from contained, the next challenge for the global IVD market lies around the corner. In Europe, the new Medical Device Regulation and IVD Regulation (IVDR) goes into effect on May 26, 2022, and will bring significant changes to the IVD testing space, with CE certification by a notified body becoming the rule rather than the exception and a new strict EU regime for in-house developed tests. Moreover, the Brexit transition period ends in December this year and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued post-Brexit guidance on IVD in the UK. This will not only impact IVD manufacturers, but also have far-reaching consequences for supply chain and distribution, notified bodies, as well as clinical laboratories who are operating in Europe.
REGISTER HERE

In this webinar, Erik Vollebregt, an expert in IVD law from Axon Lawyers, will bring you up to speed on the IVDR and will discuss the impact of the current COVID-19 pandemic on future IVD testing.

Attendees of this webinar will learn:
- Basic outlines of the new EU IVDR regime.
- New IVDR requirements around component specifications and maintenance.
- Impact of the IVDR regime on supply chain and in-house developed tests.
- EU emergency guidance in the field of IVD development.

This regulation in 2022 has me hopeful.

"In Europe, the new Medical Device Regulation and IVD Regulation (IVDR) goes into effect on May 26, 2022, and will bring significant changes to the IVD testing space, with CE certification by a notified body becoming the rule rather than the exception and a new strict EU regime for in-house developed tests."

The MDx landscape has been skewed to favoring lab developed tests. The bar is much higher for the approval of POC IVD assays. This also definitely the case in the US.

FL

ElTorro 9 oktober 2020 19:54

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Hi FL, is Novacyt's stock race still rational, with almost 46% increase in 5 days?
Furthermore I don't understand why BCART breakpoint remains @ 5, I guess the investors are waiting for proof of improving numbers..

DRTVR 9 oktober 2020 20:55

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quote:
ElTorro schreef op 9 oktober 2020 19:54:
Hi FL, is Novacyt's stock race still rational, with almost 46% increase in 5 days?
Furthermore I don't understand why BCART breakpoint remains @ 5, I guess the investors are waiting for proof of improving numbers..

Hey, the price is constantly doubling when we look at the course this year, so hopefully this will continue for a while, I am also curious what FL thinks about it.

Flatlander 9 oktober 2020 21:07

0

Hey El Torro
The difference is easy to see. Novacyt is quickly rolling out products that meet critical demand during this pandemic. I've copied their highlights from the 1st half (below). It is amazing how proficient they are in gaining approvals for products with immense need. BCART on the other hand is stuck in neutral. They have not shown much of an ability to secure IVD approvals outside of the EU. The market is in show me mode as it applies to BCART. They have to get Idylla into the POC market more quickly. Much of Novacyt/s success is attributed to their design prowess and the fortune that their focus on respiratory disease lines up perfectly with the tremendous need caused by this pandemic.

Novacyt H1 highlights
Received CE Mark accreditation and Emergency Use Authorisation from most major regulatory authorities,
including the US FDA and the WHO
• Launched three innovative products (Exsig™ Direct, Exsig™ Mag and COVID-HT) to support laboratories to
improve workflow efficiency and help address shortfall in global manufacturing and supply ofreagents
• Launched a saliva sampling type to support ease of patient sampling, lower levels of discomfort and
demonstrate more reproducible data
• Initiated a 2,000-patient clinical trial by Queen Mary University of London using the Group’s innovative nearpatient testing system
• Launched a respiratory test panel (Winterplex™) to diagnose and distinguish between influenzaA&B, RSV
and COVID-19
• Launched a two-gene target test for COVID-19 to address markets employing this testingapproach
• Launched a serology (antibody) test to detect past infection of COVID-19 with a partner
Significant opportunity to place rapid, mobile instruments for decentralised testing
settings

All this said, the pandemic will come to an end, hopefully soon, god willing. Novacyt needs to use their rapidly growing war chest to diversify. Oncology is projected to be the fastest growing area of MDx. The shift to POC is recognized to be underway. An acquisition of BCART does make sense for Novacyt assuming they can step in and accelerate product introduction to the market.

FL

Flatlander 9 oktober 2020 22:54

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www.genomeweb.com/infectious-disease/...

Again I don't have the subscription but the gist of the article title suggests that inflammatix will soon introduce their own sepsis Host Response test to the market.

FL

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