Inloggen

Login
 
Wachtwoord vergeten?

Biocartis forum geopend

Volgen
 
Klik hier om dit forumtopic te volgen en automatisch op de hoogte gehouden te worden bij nieuwe berichten.
715 Posts, Pagina: « 1 2 3 4 5 6 ... 31 32 33 34 35 36 | Laatste
Aantal posts per pagina:  20 50 100 | Omlaag ↓
Flatlander
1
Biocartis has priced their cartridges at a point where there is room for the clinic or hospital to mark it up and receive reimbursements from the insurers. With the 510(k) pathway approval, point of care users will make a nice profit off the use of Idylla. That combined with the fast turn around time will greatly expedite adoption of the platform.

FL
DeZwarteRidder
1
quote:

Flatlander schreef op 2 mrt 2019 om 17:24:


Biocartis has priced their cartridges at a point where there is room for the clinic or hospital to mark it up and receive reimbursements from the insurers. With the 510(k) pathway approval, point of care users will make a nice profit off the use of Idylla. That combined with the fast turn around time will greatly expedite adoption of the platform.
FL

Je beweert dus dat Biocartis veel te weinig geld vraagt voor het gebruik van Idylla-cassettes zodat het ziekenhuis er veel winst mee kan maken...!!!??

Dat zou betekenen dat Biocartis over 10 jaar nog geen winst maakt.
Flatlander
0
I listened to a Podcast called "Megatrends" a couple weeks ago. I'm pretty sure that the Dec 10 episode is discussing Biocartis as one of the small companies with big healthcare potential. Oppenheimer is one of the larger institutional investors in Biocartis.

FL
Flatlander
1
In the U.S the insurance reimbursement rates are determined by the specific genomic pathway panel being analyzed (BRAF, KRAS etc). The reimbursement rate will not be influenced by whether it is analyzed by a NGS method in a lab vs. an IVD test in the clinic where the biopsy is taken. Because Idylla's competitors are largely lab based with greater technician effort, reagents, steps etc. the competitors currently have much higher costs. Biocartis has chosen to initially price at a reasonable margin that puts the assay cost well below competitors. This leaves the clinical lab where the Idylla test is run the potential to mark up the costs considerably and still receive full insurance reimbursement. I believe that ones the 510(k) pathway approvals are received that the adoption rates will take off in the US since the clinics will have a strong economic reason to use the test (i.e., they can bill it out for 100% profit). It remains to be seen how Biocartis will change the cartridge billing rate once 501(k) approval is received for clinical diagnostic use. Arguably, they should increase the price.

FL
Flatlander
1
Biocartis is currently getting little credit (based on share price doldrums) for several positive developments including:
expansion of GHDX partnership into Urology;
China and Japan market expansion;
Product offering expansion in MSI;
AstraZeneca CDx partnership

Many of these deals allow Biocartis to leverage limited resources by having their partner carry some of the regulatory burden. This is important now when profitability is still a couple of years off. At times I'm frustrated that BCART has not listed in the US. Looking at how GH has performed since it IPO'd, I believe that BCART could raise a lot more cash with less dilution. I've convinced myself that this is balanced by the advantage that they are currently flying under the radar building momentum (increased product offerings, geographic expansion) without a huge target on their back. Too much visibility on the NYSE or Nasdaq would undoubtedly draw competitors. At some point I'm sure BCART will list in the US (at least it seems to be the trail that QGEN and others have taken). In the mean time BCART generated good technical reviews. I was impressed by the attached link that suggested Idylla has a place for 1st line diagnostic pathology. Placement in this setting (clinics, hospitals, small labs, etc.) would be allow huge expansion. This is obviously dependent on expanding beyond the RUO designation, That's why the emphasis on 510(k) pathway approvals are critical.

jcp.bmj.com/content/71/9/757

FL
Flatlander
0
Anyone on the board have any thoughts on the China joint venture with Wondfo. Will the intellectual property be protected adequately?

FL
tomtesteron
0
quote:

Flatlander schreef op 6 mrt 2019 om 15:27:


Anyone on the board have any thoughts on the China joint venture with Wondfo. Will the intellectual property be protected adequately?

FL


I think the wondfo JV will prove to be very successful in the future:
China is a country where due to pollution there is a high incidence of cancers. Alligning the cartridge portfolio to these types of cancers can in my perspective open a huge market potential.

I also think that Biocartis and its CEO are smart enough to be aware of the potential risk of intellectual property breaches. By choosing Wondfo as their partner, they choose a market leader in China who is also active in the US (lab in San Diego and brancg in Chicago), and in 120 countries in total. They are seen as a trustworthy partner.
Flatlander
0
Thanks, I agree with your assessment of the market potential. I hope you're right on the trustworthiness of Wondfo. When I first invested in Biocartis, I tried to research the patent portfolio. I recall that they have approximately 40 patents and license agreements protecting various aspects of their technology. Of course, this all depends on a legal system that is willing to enforce intellectual property rights.

I was a bit disappointed with the year end results but was pleased with the initiatives identified for 2019. I believe the ramp up in the U.S. is constrained because of the RUO designation. The sales reps have to be very careful not to cross the line in marketing it as a clinical diagnostic device.

I'm always intrigued by the potential for Idylla to be used to disseminate partner sponsored ads and educational material. Idylla is in effect a very valuable ecosystem that is positioned to dispense valuable information at the time of biopsy or genetic pathway diagnosis. The placement of such information or ads at such a pivotal time in the patient treatment is invaluable and could make BCART a preferred partner for CDx relationships. This is all a ways off, and BCART needs to ramp console placement and cartridge volumes before entertaining any partner sponsored ads.

I'm glad I finally found a forum to discuss Biocartis.

FL
Flatlander
0
Anyone know the status of the Immunexpress -Biocartis relationship? The attached article suggests that Immunexpressis rounding up additional funding to advance the Septicyte IVD

Assay.https://www.genomeweb.com/molecular-diagnostics/immunexpress-wins-745k-hhs-contract-rapid-sepsis-assay#.XIGYTCJKjIW

However, I don't recall any mention of it on the Feb 28 update. Furthermore, the following statement
on page 4 of the Feb 28 Press Release leads me to believe that Biocartis is terminating the ImmunExpress collaboration.

"Contract terminations – During H2 2018, a review of infectious disease oriented collaborations and license agreements was conducted, which resulted in the termination of certain collaborations that were no longer of strategic importance to Biocartis. As part of this review, the agreement with Koninklijke Philips N.V., under which Biocartis had gained access to certain patent rights and know-how, in relation to an ancillary platform for selective enrichment of pathogen DNA for use with bloodstream infection tests, has been terminated. The underlying patent rights are being returned to Philips and the related book value has been fully impaired, resulting in EUR 3.2m non-cash impairment.

The ImmunExpress relationship appears to have existed for several years (+/- 2012 -six years before last years announcement) but does not appear to be advancing.

www.debiopharm.com/debiopharm-innovat...

Other than strategic decision to emphasize oncology related assays for business/cost related reasons,, is there another factor that has limited progress on the septicyte IVD assay? The fact that this has been kicking around for so long makes it look like some type of technical constraint.

FL
Flatlander
0
Good news on the CDx collaboration with Bristol Myers for MSI. I used to get upset that BCART was operating totally under the radar in the US. Now I'm thinking it may be a strategic advantage. They have been able to secure CDx agreements with 5 major pharma companies,, launched Idylla in every major market in the world and are in the process of validating the GHDx Oncotype Dx Breast IVD assay (only test shown to predict whether a patient will benefit from Chemotherapy). If the OncoType prostate test is half as strong an assay this could be a very long running profitable collaboration. These collaborations are coming to BCART without drawing a number of copycat oncology IVD competitors.

Like they have said in many of the conference calls, this is a multiyear journey. I've switched to using these benchmarks to track progress rather than focusing on the share price,

FL.
Flatlander
0
Thanks. I'm not trying to monopolize the posts on this board. I see a lot of potential for BCART and I've been looking for a forum to discuss the company. Outside of IVD oncology competition (does not currently seem to be a concern), the major risk seems to be that NGS may get cheaper and faster in the future. That is fine, I believe that is still a ways off. There will always be a need for timely information at the time of biopsy/diagnosis.

FL
Flatlander
0
The China IVD registration process appears complex. The extent to which validation studies conducted in foreign markets may be utilized to support the registration is unclear. Once registered, the IVD test is generally not reimbursed by insurance for a period of 2 years. During this time the patient bears the cost for the test. The attached article does provide a perspective on the immense potential of the China IVD market. Looks like we should be prepared for this to play out in a 3 to 5 year time frame.
FL
www.pacificbridgemedical.com/publicat...
Flatlander
0
This statement is encouraging:

"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."

If this plays out favorably, might it be possible to launch sales of of some assays (i.e., Iung CRC) late this year? The cartridges and consoles would need to initially be imported from Belgium until local manufacturing is established.

Just conjecture.
FL
tomtesteron
0
ze hebben het echt moeilijk om over de 11.8 te gaan blijkbaar ... Blijkbaar niet veel momentum op dit ogenblik.
715 Posts, Pagina: « 1 2 3 4 5 6 ... 31 32 33 34 35 36 | Laatste
Aantal posts per pagina:  20 50 100 | Omhoog ↑

Plaats een reactie

Meedoen aan de discussie?

Word nu gratis lid of log in met je emailadres en wachtwoord

Direct naar Forum

Biocartis Meer »

Koers 11,300   Verschil -0,40 (-3,42%)
Laag 11,220   Volume 143.385
Hoog 11,980   Gem. Volume 91.920
22-mrt-19 17:35