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Flatlander
0
The MDx market has been trading in unison lately. I thought that maybe BCART might avoid some of the downdraft that the sector is experiencing, since they never caught the updraft last year. Yesterday was a tough day for most of the U.S. sector. Today it started to rally about the same time as the EU close. That should bode for a good open for BCART tomorrow.

In the anticipated news department, we are approaching the 6 month mark since ImmunExpress filed the 510K application for Septityte Rapid. If the standard FDA review schedules hold, we should hear something from the FDA in the next few weeks. That determination would open the door for Immunexpress to market the test to ERs and ICUs in the US.

BCART could use the jolt of good news.
FL
Flatlander
0
Nope, no follow through on the positive movement yesterday,. Nasdaq futures and MDx premarket are deep in the red this morning.

Lets hope for some positive news on ASCO presentations otherwise it looks like 4 will not hold.

FL
Hopende
0
quote:

Flatlander schreef op 19 mei 2021 14:27:


Nope, no follow through on the positive movement yesterday,. Nasdaq futures and MDx premarket are deep in the red this morning.

FL

i think its about 17 a clock that it begins ?
Hopende
0
quote:

Flatlander schreef op 19 mei 2021 14:27:


Nope, no follow through on the positive movement yesterday,. Nasdaq futures and MDx premarket are deep in the red this morning.

FL

but can it go much deaper then this , it would be a disaster
Hopende
0
quote:

Flatlander schreef op 19 mei 2021 15:00:


5pm ET for Abstract release.

I'm actually following it because I anticipate major news from NVS.

finance.yahoo.com/news/1-novartis-say...

i hope that we w'll have good knews , are you going to give a summery ? because you are very good in this subject
Flatlander
0
I don't think that BCART is allowed to mention any papers that are accepted by ASCO until after the abstracts are released at 5pm ET. I'm pretty sure they will put outa PR out highlighting the Idylla related abstracts. However, we might have to wait a day or two.

FL
Flatlander
0
Did not come up with anything when searching the thousands of abstracts using the keyword Idylla. This does not mean there were no papers, it might mean the filter only searches the title.

The following biomarker paper emphasis the need to expedite lung biomarker results.

meetinglibrary.asco.org/record/200447...

FL
Hopende
0
quote:

Flatlander schreef op 19 mei 2021 23:25:


Did not come up with anything when searching the thousands of abstracts using the keyword Idylla. This does not mean there were no papers, it might mean the filter only searches the title.

The following biomarker paper emphasis the need to expedite lung biomarker results.

meetinglibrary.asco.org/record/200447...

FL

Thanks for the input and effort
Flatlander
2
www.wondfocartis.com/news-list/cid/8....

I have no Idea what will happen in the translation from Chinese to Dutch.

The WondfoCartis site has a news release that indicates that they signed a "Strategic Cooperation Memorandum" on April 23 to use Idylla for precision tumor diagnosis. This is likely the same agreement that was announced in Belgium around the same time, but the fact that the agreement was signed at the China Ecosystem Conference held in Wuxi China is telling. Further, the agreement states that the two parties agree to jointly promote integration of precision diagnosis and treatment. I think the end of the release discusses securing the registration which is done on a local basis in China. The google translation is rough and incomplete. However, this is exactly where I think BCARTs niche is likely to exist. Given the prevalence of EGFR mutations in Asian countries, this is a major market for AZNs Tagrisso. Idylla looks to provide cheaper MDx results that will help make the drug more accessible to the Chinese people. I think BCART was trying to remain vague on the nature of the agreement (perhaps for competitive reasons). However, the stock really needs good news from somewhere.

FL
Hopende
0
quote:

Flatlander schreef op 20 mei 2021 18:54:


www.wondfocartis.com/news-list/cid/8....

I have no Idea what will happen in the translation from Chinese to Dutch.

The WondfoCartis site has a news release that indicates that they signed a "Strategic Cooperation Memorandum" on April 23 to use Idylla for precision tumor diagnosis. This is likely the same agreement that was announced in Belgium around the same time, but the fact that the agreement was signed at the China Ecosystem Conference held in Wuxi China is telling. Further, the agreement states that the two parties agree to jointly promote integration of precision diagnosis and treatment. I think the end of the release discusses securing the registration which is done on a local basis in China. The google translation is rough and incomplete. However, this is exactly where I think BCARTs niche is likely to exist. Given the prevalence of EGFR mutations in Asian countries, this is a major market for AZNs Tagrisso. Idylla looks to provide cheaper MDx results that will help make the drug more accessible to the Chinese people. I think BCART was trying to remain vague on the nature of the agreement (perhaps for competitive reasons). However, the stock really needs good news from somewhere.

FL


Thanks jou again fingerscrossed
Flatlander
0
Hopende

Glad you could access it and make sense of it. Sometimes the Chinese PR statements are very hard to understand.

FL
OzDx
0
Thanks for your contribution FL. I've been topping up whenever SP is on the low end of $4 - $5 range. Not concerned about daily movement of SP. My only concern for companies like this is they get acquired at low valuation... Fingers crossed!
Flatlander
0
OZDx

I've harbored those concerns at points in the past. But the fact that the shares are so widely disseminated in so many hands, makes it a high bar to pull off anything that the bulk of the investors don't think is in their best interests. I think the BCART news flow will ramp up in the 2nd half of this year. However, in many instances it appears that they skip the PR or make it so vague that it is incomprehensible. The AZN PR is a good example. The Chinese release provides a few more details that allow investors to connect dots. I don't think BCART wants to draw attention to efforts in China and the EM.

I'm concerned about Novacyt being a takeout candidate. They are literally waiting until the end of June to hold their 2020 EOY conference call. They will have a heck of a war chest that might amount to cash holdings equal to 3/4 of the market cap by the end of 2021. If you look at how much Roche paid up for Genmark, Novacyt is dramatically undervalued. They are almost always first to market with new COVID related products and were quick to launch PCR tests for each of the variants of concern. I suspect that the market is pricing in a end of the Pandemic (not a virus that becomes endemic) and a steep drop off in sales. However, Primer Design has a variety of agreements for innovative MDx products. I'm a bit concerned that their relationship with ImmunExpress might lead to a 2nd generation sepsis test. Either way, the next conference call will detail their pivot plan for post COVID. Like BCART, Novacyte has been fighting a market headwind.

Regards FL
OzDx
0
I had a quick look at Novacyt, and the problem I see with Novacyt is they had a once in a life time sales boost from sales of Covid-19 kits as seen. Sales in Europe went from €1,352 to €58,040. I don't see Lab21 products scaling up at all because it looks like they provide small scale lab consumables and primer design products don't seem like they have a competitive edge/advantage over any other qPCR products. This is just my opinion after a quick look of their financials and products. I would like to know your thesis in Novacyt?
OzDx
0
Actually SNPsig products look very appealing. Is that where the investors in Novacyt see growth will come from? Or potential acquisition offer?
Hopende
0
quote:

OzDx schreef op 21 mei 2021 05:32:


Actually SNPsig products look very appealing. Is that where the investors in Novacyt see growth will come from? Or potential acquisition offer?

i still hope that bioccartis will be sold to an other firm because the procress is slow en there are many apponents
OzDx
0
Has anyone read this article published in March this year?

"Rapid EGFR Mutation Detection Using the Idylla Platform: Single-Institution Experience of 1200 Cases Analyzed by an In-House Developed Pipeline and Comparison with Concurrent Next-Generation Sequencing Results"

I've just copied important bits from the article for my note... if anyone's interested

? Incorporation of the Idylla assay did not adversely affect subsequent NGS testing.
? In concordance with our experience, other studies have also shown the suitability of samples other than FFPE tissue for testing by the Idylla system, including cytology samples, decalcified tissue, and extracted DNA
? Although the Idylla EGFR assay is marketed specifically for FFPE tissue, a variety of input materials and samples can be used with the assay, with acceptable performance parameters. This versatility of the assay has been demonstrated in small studies and case reports for even stained cytologic material.
? Comparison of the Idylla results with the concurrent NGS data highlighted several important points. Overall, the automated mutation calls by the Idylla software alone demonstrated high concordance [98.75% (789/799)] with NGS results for the mutations included in the Idylla assay design. The rate of success of the Idylla assay and the concordance rate in this report are in keeping with prior studies, despite the use of more limited tissue and input material other than FFPE. Previous studies report overall concordance rates of 90% to 98% between Idylla and other orthogonal assays.9,24,26,33, 34, 35, 36 As in our experience, most studies have attributed the false-negative results to low tumor content in the sample.
? More importantly, neither the Idylla software nor the in-house automated analysis generated false-positive results. This high specificity means that positive calls do not require confirmation by an alternate test, enabling clinicians to initiate treatment in a timely manner. False-negative calls, however, are more concerning as, even in the context of minimal tissue loading, the Idylla system rarely generates a failure result. Therefore, in the context of limited tissue, any negative result should be interpreted with caution and must be carefully correlated with the total EGFR CQ and the tumor content before issuing a negative report.
? In conclusion, we find that the incorporation of the Idylla system enables streamlined rapid assessment of the most common mutations in non–small-cell lung cancer while still allowing comprehensive NGS assessment for the vast majority of samples with high success. The average turnaround time for this assay from receipt of material to report sign out is under 3 days, even accounting for extra steps of extraction and library preparation in small samples. The development of an in-house analysis pipeline can streamline additional processes in the laboratory, particularly when it incorporates flagging capabilities for borderline cases to prompt additional testing before final reporting. A manual review process, such as the one described herein, may also be easily incorporated in conjunction with the proprietary Idylla software analysis.


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