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ElTorro
0
De vraag is ook hoelang het nog gaat duren voor er goedkeuringen gaan komen in US.. het is als wachten op Godot.

Ook over andere topics (reagens stock, productie, verkoop, cashburn) bestaat er vandaag niet echt duidelijkheid, en moeten beleggers zelf xls schema's beginnen uitdokteren om enigzins te bepalen of het bedrijf de goeie richting uitgaat.

Met al die zaken is het management al een hele tijd 'bezig', hoog tijd voor progressie.
Flatlander
0
El Torro
You ask and the US delivers!
FDA Clears SeptiCyte® RAPID – The First One-Hour, Direct-from-Blood Sepsis Test

Fully automated diagnostic tool SeptiCyte® RAPID quantifies the relative expression levels of genes involved in a patient's immune response to infection to aid in a diagnosis in one hour for patients suspected of sepsis

SEATTLE and BRISBANE, Australia, Nov. 30, 2021 /PRNewswire/ -- Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced that SeptiCyte® RAPID has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The cleared test is an aid in differentiating sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis.
Flatlander
0
Immunexpress has been a leader in host response sepsis diagnostics, and this second FDA clearance translates its biomarker technology to the sample-to-answer Biocartis Idylla™ near-patient testing platform. SeptiCyte® RAPID contains all the reagents needed for quantification of gene expression using a reverse transcription polymerase chain reaction (PCR) to determine the relative expression levels of host response genes directly from whole blood. The process is fully automated in a user-friendly, hands-free format, and a result is obtained in one hour.
"SeptiCyte® RAPID has the potential to transform sepsis diagnosis, addressing a critically unmet need in the ICU," said Roy Davis, M.D., Ph.D., Chief Medical Officer of Immunexpress. "SeptiCyte® RAPID has been evaluated in hospitals since 2019. Major hospital systems with which we have worked are anxiously waiting to incorporate this into the current diagnostic tool set, allowing clinicians to make swift and accurate clinical decisions, ultimately improving patient outcomes."
Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress, commented, "It has been a long journey to transfer our clinically proven novel biomarker technology from our 8 hour FDA-cleared SeptiCyte® LAB product in 2017, to the advanced 1 hour sample-to-answer Biocartis Idylla™ testing platform. This FDA clearance could not have been achieved without the dedication of the Immunexpress team, the support of our investors, and our clinical partners around the globe."
The increasing incidence of sepsis, which has accelerated with the COVID 19 pandemic, is well recognized and has been generally attributed to the growing prevalence of chronic conditions in aging populations. The clinical presentation of sepsis is often hard to identify early; fever is not always present, and it can often go unrecognized clinically for extended periods. Sepsis remains a leading cause of morbidity and mortality among intensive care unit (ICU) patients. For each hour that treatment initiation is delayed after diagnosis, sepsis-related mortality increases by approximately 8%[1]. Therefore, maximizing effective care requires early recognition and initiation of treatment protocols. SeptiCyte® RAPID will be the first FDA cleared test to differentiate sepsis from non-infectious systemic inflammation to aid in a sepsis diagnosis within approximately one hour for patients suspected of sepsis.
FDA clearance was based on data from retrospective and prospective studies validating the clinical accuracy of SeptiCyte® RAPID. The retrospective clinical study included 8 sites in the United States and Europe from the MARS clinical trial (NCT01905033) and VENUS clinical trial (NCT02127502). The prospective study, NEar PatienT MolecUlar TestiNg in SEpsis (NEPTUNE), evaluated real-time performance of SeptiCyte® RAPID in a clinical setting at Emory University, Rush University and the University of Southern California. In both retrospective and prospective studies, the sepsis status of patients was determined by a three-member panel of expert physicians. The data reinforces the utility of quickly testing the patient's immune host response to determine if there is an underlying sepsis infection. Immunexpress will immediately commercialize SeptiCyte® RAPID to ensure broad availability across the United States in 2022.
FL
Flatlander
0
When I initially invested in BCART one of the key premises was that partners and content developers would utilize their salesforces to sell the Idylla platform and the assay content. It only took 3 years for that basic premise to start being realized! Unfortunately, I was hoping that one of the bigger partners with large sales teams (AZN, BMY, GHDX-EXAS, etc) would be the ones marketing but at this point I'm happy to see any help on this front. Now the question is what royalty will be paid for Septicyte Rapid assays sold in the US. I'm guessing in the neighborhood of 10%. This is not a primary concern if Immunexpress are successful placing consoles in Emergency Rooms and ICU's, I think the growth of the user network is the most important thing at this point.

FL
Flatlander
0
I really like this statement.

"Immunexpress will immediately commercialize SeptiCyte® RAPID to ensure broad availability across the United States in 2022."

The negative side of this announcement is that we are likely now closer to hearing the plan for raising cash. My preference is that the dovetail the MSI approval (any day now?) along with an announcement of a listing on the Nasdaq.
FL
CGCDLR
0
Een doorbraak! Het enige die nog boven de markt hangt is een kapitaal ophaling.Hopelijk doen ze dit nu snel
Bonsjoer
0
Eindelijk eens wat positief nieuws !, benieuwd of de koers morgen dit goed oppikt.
Flatlander
0
This is big news for the reason we have discussed ad nauseum. With the exception of the JnJ RSV approval in 2017 (a test that went nowhere) since there was no follow thru, this is the first non RUO launch in the US. This is starting point to open the US market. I would think MSI approval goes faster since there is an abundance of favorable head to head test results against MSI test methods that are already approved by FDA.

FL
Flatlander
0
Best thing BCART could do to support the Septicyte Rapid launch is quickly announce if the Covid Assay is capable of detecting the Omicron variant. Idylla is likely to be used despite the EUA approval for COVID testing. data supporting this use would be helpful.

FL
Thole
0
De Tijd heeft het nieuws al opgepikt, er staat al een kort artikel over op hun site.
Flatlander
0
The timing of Septicyte Rapid approval was critical. A lot of US hospitals have capital expenditure budgets that correspond to the calendar year. Often (at least during typical non-pandemic years) purchasers find themselves in a "use it or lose it" position meaning that if they do not buy something with the funds before Dec 31 they will revert back to a general fund and be used elsewhere. ImmunExpress has probably already been focused on filling these channels for weeks. I would not be surprised to see a year end pop in the number of consoles sold.

FL
Stockbrood
0
quote:

Flatlander schreef op 30 november 2021 20:55:


The timing of Septicyte Rapid approval was critical. A lot of US hospitals have capital expenditure budgets that correspond to the calendar year. Often (at least during typical non-pandemic years) purchasers find themselves in a "use it or lose it" position meaning that if they do not buy something with the funds before Dec 31 they will revert back to a general fund and be used elsewhere. ImmunExpress has probably already been focused on filling these channels for weeks. I would not be surprised to see a year end pop in the number of consoles sold.

FL


Seems as Flatlander changed from dark to pink shaded glasses :D

Sorry Flat, small joke should be OK. ;)

Stock
CGCDLR
0
Dit zal de concurrentie ook wakker schudden,een goed gekeurde test, Biocartis kan hierdoor gemakkelijker Idylla's plaatsen & sneller andere testen aan de man brengen! Hopelijk krijgen we niet te maken met een opportunistisch bod,aan de huidige goedkope waardering zou dat een buitenkansje zijn.Geld is er momenteel in overvloed, voor sommigen toch.
Hennie76
0
19:04
Groen licht in VS voor sepsistest van Biocartis

De Amerikaanse geneesmiddelenwaakhond FDA geeft toestemming om SeptiCyte RAPID, een snelle test die werkt op het Idylla-platform van Biocartis
BCART
-3,23%
, in de VS op de markt te brengen. Een jaar geleden was er al groen licht voor de sepsistest in Europa.
De test werd ontwikkeld door Biocartis’ partner Immunexpress. Dit in Seattle gevestigd moleculair diagnostisch bedrijf zal ook de commerciële uitrol in de VS op zich nemen. ‘Voor Biocartis zullen de commercialiseringsinspanningen in de VS naar verwachting de installed base van Idylla™ in de VS uitbreiden en de volumegroei van de cartridges versterken’, zegt Biocartis in een persbericht.
Sepsis of bloedvergiftiging is een levensbedreigende reactie van het lichaam op een infectie die het immuunsysteem ontregelt. In 40 tot 60 procent van de gevallen zijn artsen het oneens over de juiste behandeling omdat er op dat moment geen nauwkeurige diagnostiek beschikbaar is die uitsluitsel kan geven. Conventionele technieken zijn traag en vaak niet erg nauwkeurig. De sepsistest van Immunexpress/Biocartis levert binnen ongeveer een uur resultaten op.
OzDx
0
FL, Idylla SARS-CoV-2 test targets N and ORF1b genes which are known to be unaffected by Omicron variant. Imo, they wouldn't announce it unless they get their hands on Omicron variant positive sample.

Biocartis seriously needs another manufacturing line, they're already struggling to meet the demand as it is. I can imagine many sites wanting to trial Septicyte RAPID with the news of FDA approval. What I would like to see is distribution rights being sold to bigger players.
Flatlander
1
quote:

Stockbrood schreef op 30 november 2021 20:59:


[...]

Seems as Flatlander changed from dark to pink shaded glasses :D

Sorry Flat, small joke should be OK. ;)

Stock


Funny, in the U.S. they're referred to as "rose colored glasses".

Stockbrood
I try not to maintain a level of objectivity and was mad (in August) at the thought that the fire might derail what looked like a decent turnaround. By the same token, BCART, for way too long has been constrained by RUO sales limitations in the U.S. I'm thrilled by the prospect of some of these restrictions finally being lifted.

Regards FL
Flatlander
0
Hi Oz,
My one regret with the Septicyte Rapid approval is that it is less likely to have any synergy with the oncology related assays that are the mainstay of BCART's offerings. Unfortunately Emergency Departments and ICU's tend not to be located all that close to oncology areas of major hospitals. In smaller more rural areas there might be some usage across these areas.

I'll guarantee that Immunexpresses marketing effort touts the fact that Idylla can be used for SARS-CoV-2 and possibly SARS-CoV-2/Flu/RSV in the future. That's why a statement about Omicron detection even though it should be a given would be useful. I believe the Sept PR indicated that the timing of a filing in the SARS-CoV-2/Flu/RSV combination assay in the US was not yet decided. We are potentially looking at a worst case respiratory virus season, so this offering would have significant synergies if offered in combination with Septicyte Rapid. The Covid test was covered by the FDA emergency waiver (allowed sales in the US at risk). I'm uncertain if BCART has continued to press FDA for the EUA approval that would infer a greater level of scrutiny to those purchasing the assay.

The RSV assay was previously approved by FDA in 2017 but was not significantly marketed presumably due to already entrenched competitors (Cepheid, etc.). Given the potential for a bad flu/covid infection season, I'd hazard a guess that BCART is in the process of pursuing an EUA for the combined test. If they filed in Sept or October they might be able to receive approval during early 2022. Cepheid got EUA approvals in a couple months.

www.cepheid.com/en/coronavirus

www.investor.jnj.com/media-center/pre...
Flatlander
0
Your comment about the production line and presumably reagents is one that gnaws at me all the time. We know ML2 is running, although they are likely constrained by reagent availability. We know that during the shutdown period they were prioritizing partner content (presumably Septicyte Rapid in the EU). I'm uncertain if the prioritization is continuing now that ML2 is restarted. The one point that we have briefly discussed is that the China registration requires the establishment of ML3 in Mainland China. They have said that they expect registration in late 2022. So presumably, the construction of ML3 is already under way so that final registration testing can occur during mid to late 2022.. Information on this topic is almost non-existent from the company. Presumably for competitive reasons. But the timelines that we have been given suggests that some of these ML3 preparations are already under way. If so, I wish they would say so, it would help explain the drag on margins during the last half year update.

FL
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