I think you will find the quality here is better than Avanza (at least for the parts I used to visit 
), so do stick around. Usually topics that become more international will shift towards English (for example the Smart Eye thread when it was more active), so you don’t need a translation tool.
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I think also that it would be very polite to use English here as most digging and commenting comes from non Finnish person!
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Tässä vielä tuo ylempi uutinen suoraan:
AroCell plans to complete TPS CLIA registration in the Chinese market before the end of the year. AroCell is now expanding the collaboration in the Chinese market by including TPS CLIA on Fosun Diagnostics’ fully automated system. Through this collaboration, AroCell’s market coverage in the Chinese market for tumor markers is doubled.
As previously informed, AroCell’s subsidiary IDL Biotech has a collaboration with ZECEN Biotech, regarding the automation of the tumor marker TPS® on all their instruments. The development project of TPS CLIA has been completed and the registration process for regulatory approval of TPS CLIA for the Chinese market continues as planned. The product is planned to be available on the Chinese market in early 2023.
The development project has been successful, and we are now including Fosun Diagnostics’ fully automated system to further expand the market in China. The product is expected to be registered on the market during the second quarter of 2023. In total, both companies have more than 2,000 automatic CLIA systems. This is a part of AroCell’s strategic plan for automation.
“The development project with ZECEN Biotech has been very successful and we are now happy to conclude another agreement with Fosun Diagnostics. Launching our products on automated platforms is an important step. Automated instruments are a must for large hospitals as analyses can be carried out on a large scale quickly and efficiently. This also opens opportunities to launch several of our other products on automated platforms in China,” says Marie Torstensson, Chief Market and Sales Officer Laboratory Test.
According to the agreements, ZECEN Biotech and Fosun Diagnostics will pay a royalty to AroCell based on sales in China. Several factors will affect earnings. These factors are uncertain and prevent us from predicting future earnings at this stage.
Fosun Diagnostics is a division within Shanghai Fosun Pharmaceutical (Group) Co Ltd, focusing on developing, manufacturing, and distributing in vitro diagnostics (IVD) products.
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Found this article further developing on acute sepsis, published February 2022, in which Per Venge show that HNL is a very interesting biomarker capable of rapidly determine the outcome of antibiotics treatment in sepsis.
“Our results indicate that neutrophil activity is rapidly turned off by adequate antibiotics treatment and the eradication of the bacteria. Thus, the assay of plasma HNL Dimer concentrations may be a unique means of monitoring the success of antibiotics treatment in sepsis and probably also in other bacterial infectious diseases.”
Source:
A speculation is that such interesting results, on HNL in sepsis, may also be of relevance to AroCells TK1 biomarker - which have been shown to have capacity to be able to distinguish between infections caused by mycoplasma pneumoniae and other types of infections.
This have been established through studies on sTK1p in combination with HNL and including other biomarkers, such as CRP and PCT (also Per Venge is the co-inventor of the pending AroCell patent application “Respiratory Infection Detection and Classification”).
A speculation is that this capacity of TK1 to recognize mycoplasma infections, may turn out to also be of relevance in an acute sepsis situation? To make informed decisions on antibiotics treatment is of course highly important in a situation of acute sepsis. And there is also the problem of overuse of antibiotics that would be adressed through more informed decisions (all this is amateur-speculation, of course).
A necessary prerequisite would be that a competent sTK1p rapid test is developed - either by AroCell or by another company licensing the AroCell TK1 technology.
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In my view the following Chinese perspective on early cancer screening is very interesting. Allthough such ideas seldom (as I understand) show up in the Western political landscape or Western approach to early screening, nevertheless this article captures, in my view, a relevant approach to early screening.
Here is a quote from the article, which is published by SSTK Biotech (translated by Google).
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Why do we need to screen early? What to do after early screening?
Clinical tumors are comprehensively judged by symptoms, signs, tests and imaging methods, and finally diagnosed by the gold standard of pathological examination. But we know that the occurrence and development of tumor is a long-term progression process, and clinical tumor is the end event of this process. In the years or even longer before the end point event, although we cannot make a clinical diagnosis of the tumor, early detection of the occurrence and development of this event is the significance of early cancer screening .
So why early cancer screening? In addition to helping clinicians detect tumors at an early stage, it is actually more important to help clients avoid tumor risks before clinical diagnosis of tumors.
Also based on the above understanding, our follow-up work after early screening is in two aspects:
1. For customers who are close to the end point, we can help clinicians detect and diagnose tumors early;
2. For earlier customers, although we cannot diagnose tumors yet, we can change our lifestyle through health management to prevent or delay the occurrence of tumors.
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As a society we could, in my view, potentially save tremendous amounts of future resources by trying to implement meaningful strategies for individual health awareness resulting in an overall healthier Western population.
Again - one of the key messages from the article:
it is actually more important to help clients avoid tumor risks before clinical diagnosis of tumors.
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Arocell vastasi sähköpostiin, liityen uusiin verkkosivuihin:
Thank you for your question.
The website will be launched relatively soon.
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Redeye Theme: Diagnostics / AroCell / Attana
September 27
https://www.redeye.se/events/846227/redeye-theme-diagnostics
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On early cancer screening - according to this recent article (published June 2022) it appears as if very large trials on early cancer screening are being planned in the US in the coming years.
Interesting article, which also brings some questions of pros and cons with early cancer screeening.
Nice to see these topics being officially adressed and maybe starting to be part of the Western agenda!
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AroCell presentations both September 27 as well as September 29!
RedEye - Investor Forum Online / AroCell
September 29
https://www.redeye.se/events/844484/investor-forum-online-11
NOTE! Companies and schedules may change before the event starts.
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Here is, as background information, a link to a CV-presentation of Henrik Rönnberg (alias von Euler).
Very impressive and inspiring. In my (amateur) view, Henrik is one among those classic TK1-experts who over the years has brought important contributions to TK1 science.
Source (written in Swedish - use google translate):
Apparently Henrik also has been participating in the development of a cancer treatment for ovarian cancer.
“For several years I worked part-time as medical director at a company that developed new cancer treatment for dogs and humans. During this period, I helped develop a treatment for ovarian cancer in women that was finally registered and approved by the EMA, the European Medicines Agency.”
When will all this worldclass knowledge surrounding AroCell, and all this development on TK1 during the years, when will all this reach a critical level and start to manifest in real world achievements for AroCell?
One year? Two years? Ten years? Never?
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Some background findings, bladder cancer…
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A working fully functioning webbased calculator
When searching for potential real world applications of AroCells technologies, the following apparently functional and useable index was interesting to find. It appears to be a fully functioning calculator, based on the study of nomograms which includes the UBC Rapid test.
Apparently there is a need for better diagnostic tools in different aspects of the management of bladder cancer, both advanced stages as well as primary early detection:
Source: Nomograms including the UBC® Rapid test to detect primary bladder cancer based on a multicentre dataset https://www.diva-portal.org/smash/get/diva2:1622083/FULLTEXT01.pdf
Background info - nomograms: Nomogram – Wikipedia
Ok, so apparently the allready marketed UBC Rapid test shows great promise. And probably the scope of this test will increase even further when also adding the cytokeratin 19 parameter in the new version of the test that is now being developed, both for the US and the European market (UBD Rapid and UBC Rapid II).
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Thorsten Ecke ISOBM
It looks like Thorsten Ecke maybe will share new data on UBC Rapid in bladder cancer in the upcoming ISOBM congress October 13-17.
https://www.isobm2022.net/programme/
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Trodelvy, Jonas Söderholm, Gilead Sciences
Talking about bladder cancer, maybe notable (as background info) could be the development of the cancer treatment Trodelvy (by Gilead), in which former AroCell Global Medical Lead, Jonas Söderholm appears to be actively participating.
Senior Medical Manager, Oncology, Gilead Sciences
“Launching Trodelvy in breast cancer.”
https://se.linkedin.com/in/jonas-söderholm-14b4767
Trodelvy (first in class, delivering chemotherapy) - breast cancer, bladder cancer:
“Trodelvy® (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers.”
(Maybe worth noting - Biovicas DiviTum is not further developed towards chemotherapy treatment lines in breast cancer.)
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Christina Meisl, Doctoral Student at Charité - Bladder Cancer Research
“Eager to find out how we can combine clinical expertise and data engineering to find the best solution for every patient. Medical student with focus on urology and passion for quantitative methods.”
“Award for the presentation of the interactive bladder cancer risk assessment tool BLUCAB Index®, which is bestowed once a year on outstanding young scientists.” (based on the UBC Rapid test)
https://www.blucab-index.net/
https://de.linkedin.com/in/christina-meisl-020ba8205
“With BLUCAB index you can rapidly assess the risk for low-grade, high-grade and general bladder cancer for your patient and get a recommendation for your further action in just one minute. To improve safety of your patients and reduce the number of cystoscopies.” BLUCAB Index(R) UBC Rapid Version on Vimeo
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MM African Technology - according to this recent post on Facebook, this may be a new and not yet announced distributor of TUBEX on the African market?
"ANNOUNCING A NEW PRODUCT IN OUR RANGE /…/
TUBEX® TF is a rapid and sensitive in vitro diagnostic test for detection of acute typhoid fever."
Source (appears to be published on Facebook 2022-09-21):
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Looks as if former AroCell board member Per-Anders Abrahamsson now holds a position as Scientific Advisor to the STHLM3 project. https://www.a3p.com/en/scientific-advisory-board/
This may be a quite recent engagement by professor Abrahamsson - according to Wayback Machine, no such STHLM3 advisory board was officially established April 2022. A3P Biomedical -
One can only hope that Per-Anders maybe will push for a future expansion of the STHLM3 panel of biomarkers, also including AroCells sTK1p.
And that would probably be not at all irrational - the 30 year followup study on sTK1p in prostate cancer is unique and very promising. Also accompanied by extensive research in China on the usefulness of sTK1p for early detection in large screening studies.
https://www.researchgate.net/publication/359290648_Serum_thymidine_kinase_1_concentration_as_a_predictive_biomarker_in_prostate_cancer
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Apparently Alertix have made changes in the board of directors. Thomas Lund is new board member since June. Göran Beijer seems to have left the board of Alertix.
Source (Thomas Lund, linkedin):
https://se.linkedin.com/in/lundtomas
Source (Alertix, English website):
This change of directors has been announced on the Alertix English website, but apparently NOT on Alertix Swedish website.
Source (Alertix, Swedish website):
So why have Alertix changed the information on the English website, but not on the Swedish?
I think this is an interesting phenomena - why do companies so often neglect to communicate properly through there own website? Often the information on company websites is not updated for ages.
And especially in this case - why did Alertix bother to update the English site, but not the Swedish?
To simultaneously update the Swedish site would have been extremely easy - given the fact that somebody at Alertix obviously did make that change of information, regarding the board of directors, on the English site?
I think such things are mysterious… why didn’t Alertix simultaneously update the Swedish website?
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Sorry, I have this nagging thought, that won´t go away, about the failed Rhovac trial - this is just pure amateur speculation, do not spend time on reading further if you don´t like speculations…
The aim of the Rhovac cancer vaccine candidate in the failed study was to delay, or prevent, the development of metastasis in patients with prostate cancer.
To measure the effect of Rhovacs cancer vaccine in the study, a group of prostate cancer patients was selected that had undergone treatment with intention to cure (radiation or resection of local tumor).
The study started when these patients, after some time, had reached so called “biochemical recurrence”, which in the study was defined as the “doubling of PSA” values.
Ok… so the group of patients had initially prostate cancer, and by treatment with either radiation or resection of the local tumor, the patients where then defined as having no prostate cancer. Then some time passed, and in some of the patients there were indications that the cancer was recurring - this event was defined as “biocehemical recurrence” and in the study protocol defined as “doubling of PSA values”. These specific patients, who had reached “biochemical recurrence”, were selected and participating in the BRaVac study.
Ok… but a problem here (in my amateur mind) might be the following:
At this particular time event when reaching “biochemical recurrence” - how can you be sure that some of the patients, or many of the patients, have not allready developed metastasis, or passed a critical level in the emerging landscape of developing metastasis?
The Rhovac treatment candidate is ment to prevent the development of metastasis, but if metastasis allready exist, or is in development, then the treatment will maybe have less effect, or no effect?
So… to be able to correctly measure the effect of the Rhovac treatment, it would be utmost critical to define and select patient groups that can be defined as having very low probability of allready having developed metastasis?
Ok, a doubling of PSA (as defined as “biochemical recurrence” in the BRaVac study) give information on local development around the prostate, but rising PSA values would give no information on metastasis outside this region of the body? Am I right here?
Maybe there could have been emerging metastasis in some patients even before the radiation/resection event? As I understand, there is currently no clinically established way of obtaining information on any such emerging metastasis, of unknown location in the body. For example, circulating tumor cells should only work on allready established spread tumors, not on emerging metastasis?
If this is valid thoughts, then it may be appropriate to add an additional method to the study protocal, a method that helps in defining risk of probable metastasis at the starting event in the study. Thereby this method would help the study by defining a more relevant patient group participating in the study - that is patients with higher probability of having no metastasis at the starting event of the study.
Maybe sTK1p could be such a biomarker, that could help selecting patients with less probability of having allready developed metastasis at the starting event? If so sTK1p could help strengthening the study protocol, and make it more likely that the Rhovac treatment would show a positive effect in the study?
Maybe I am totally wrong, but it seems logical that the effect of the Rhovac treatment, with the intention to prevent the development of metastasis, should preferably be measured on patients with as low probability as possible of having allready developed metastasis?
In the 30 year followup study of measuring sTK1p in relation to prostate cancer, there is this following statement from the authors:
"A possible area of use is the evaluation of the probability of metastatic disease at the time of biochemical recurrence."
Isn´t this looking very interesting? To be able to help in better defining metastatic or not metastic disease at the time of biochemical recurrence?
The time of biochemical recurrence - this is exactly the critical event in the Rhovac study. If the patients would have been better defined as having no metastasis, maybe the outcome of the study would have had higher chanses of being positive?
About Rhovac and the failed study (BRaVac):
Probably this is all totally wrong, of course. Otherwise Rhovac had, of course, allready tried this…
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Interesting article, showing (new?) results for UBC Rapid from the German Prospective Multi Center Study:
Title:
IBCN 2022: Uromonitor®, BTA Stat®, Alere NMP22® BladderChek®, and UBC® Rapid Test in Comparison to Cytology as Tumor Marker for Urinary Bladder Cancer: New Results of a German Prospective Multicentre-Study
/…/
Conclusion:
BTA stat® and the quantitative UBC® rapid test showed higher sensitivity in detecting BC compared to urine cytology, but at the expense of lower specificity. A dual combination of these two tests outperforms urine cytology in terms of higher sensitivity and specificity, making them a potential alternative for the detection of BC.
Source:
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Some thoughts on the Roche development - the following, which can be read in AroCells ongoing patent application on Mycoplasma Pneumonaie, may be worth noting when speculating on whether Roche are still interested or not in AroCells TK1 technology.
This is a quote from AroCells patent application, thus apparently 100% in agreement with AroCells future development planning:
"In a further embodiment, the antibody or the fragment thereof is a monoclonal antibody or a fragment thereof as disclosed in WO 2019/201901.
For instance, the monoclonal antibody could be mAb 6C6, mAb 4H4 or mAb 23C11."
Source (the AroCell patent application on Mycoplasma Pneumonaie):
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Now… it is totally 100% clear that this quote from the AroCell patent application - which includes the 6C6 antibody - refers to the ongoing TK1 development by Roche. And not only the 6C6 antibody from Roche - AroCell also includes a reference to one of the Roche TK1 patent applications!
Source (Roche TK1 patent application, as included in AroCells patent application):
So… why (??) would the patent application from AroCell include a paragraf that, as I understand (as an complete amateur), in effect give Roche the legal rights to use TK1-antibodies developed by Roche on an invention made by Staffan Eriksson and Per Venge through AroCell science??
This can not, in my view, be understood in any other way than that the ongoing joint TK1 development work is based on a truly solid foundation - which is here manifested in the fact that AroCell and Roche together share the technological platform in this patent application by AroCell.
Why would AroCell share technological imperatives with Roche in this patent application - if there would be no future in the joint development projekt? The written legal consent, that AroCell give to Roches mAb 6C6, would make no sense at all - if AroCell did not foresee any kind of reward later on, coming from the joint TK1 development.
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I’m more wondering why Roche has not bought AroCell already. They could already have done it with coffee money back in H1 2021, let alone now when the share price is 10 % of H1 2021. It’s not about money and they risk a competitor buying them through a hostile takeover. So why hasn’t a competitor done it either? There must be something that bothers both Roche and competitors, despite the good test performance.
And while FDA approval costs more for big companies, it’s still pennies for them.
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