Maybe the risk of a hostile takeover is not that big… after all the 10 largest shareholders in AroCell have +40% of votes and capital. From this point of view the IDL merger brought an improved ownership structure in AroCell. And there are rules of flagging, should anyone “secretely” starting to buy a lot of shares - I think flagging rules is effected for shareholders with more than 5% of the shares??.
When AroCell bought IDL there needed to be more than 80% of the shareholders of IDL accepting the bid, if I remember correctly.
Edit: if Roche, hypothetically, is interested of buying AroCell than maybe the pricetag would very much depend on the combined status of all ongoing patent applications? So, maybe it is difficult to make a correct valuation of AroCell, that will satisfy both companies, unless the overall situation concerning the ongoing patent applications is resolved?
Arocellin osakekurssi nousee jos vähänkin enemmän joku haluaisi ostaa.
Varsinkin euroiksi muutettuna Arocellin vaihto on niin pientä, että ilman kurssin moninkertaistumista kukaan ei voi ostaa merkittävää osuutta yhtiöstä pörssistä
Title: “Analytical and clinical characterization of an optimized dual monoclonal sandwich ELISA for the quantification of thymidine kinase 1 (TK1) protein in human blood samples”
AroCell seems to have participated and been one of the exibitors at “Urologidagarna” (urology days) in Malmoe 5-7 October. Last day of the event was yesterday.
Another soon upcoming event that may be of interest is the ISOBM Congress (13-17 October).
A speculation is that data relevant to the UBC Rapid test perhaps will be presented.
Also of hypothetical interest from the upcoming ISOBM Congress 2022:
Friday Oct 14, 1130-1300, “Prostate cancer” (including a session on the Prostate Health Index, PHI)
Sunday Oct 16, 0830-1030, “Significance tumor biomarkers for tumor aggressiveness”
(Presenters here, Oct 16, are Vivian Barak and Ondrej Topolcan - both having participated in earlier research on TK1)
This is just unimportant background info, just for the purpose of entertainment.
On the Avanza Forum, when that forum did exist, there was a lengthy “debate” over several years concerning the name of the company - AroCell. What exactly does “Aro” represent? Allthough many interesting, and even humoristic, suggestions were proposed, nobody seemed to really nail down a definite answer to this very important question.
So, with that perspective in mind, I was a little excited when doing a casual search on Corgenix - one of AroCells partners - I found this company AroTec.
The main owner of Corgenix have, up until last year, been the parent company Orgentec. During last year Orgentec was aquired by a company named Sebia. Now - when reading about this deal, it turned out that the Orgentec group of companies also included this New Zealand company named AroTec.
So, of course, this does not mean anything at all in relation to AroCell… but, nevertheless, as the meaning of the paraphrase “Aro” is not at all clear, in this context of proteins, it was quite a coincidence to find this other company, AroTec, within a somewhat related space as AroCell.
AroCell is cooperating with Corgenix in the clia-lab space in the US.
Corgenix have Orgentec as parent company.
Orgentec is, besides being parent company of Corgenix, also operating AroTec.
And, when now having these TWO company names - AroCell and AroTec - within this quite small and related business space (biotech/proteins), and also within a somewhat related group of companies, it may seem even more relevant to be able to define a definite answer to the question of the meaning of “Aro” in this specific context.
Sources:
Again… this forum post was, of course, intended just as some kind of entertainment.
PLOS One -lehdessä on julkaistu artikkeli, jossa tutkimus osoittaa AroCell TK 210 ELISA -määrityksen vankuuden ja yksinkertaisuuden verrattuna TK-aktiivisuusmäärityksiin.
It means that the valuation of the company is not correct at the moment. Once the AroCell FDA process is back on track, the shareprice could easily reach at least 2:-, and that is also in line with recent analysis from RedEye research (of course only a personal opinion).
The bottom line is that the scope and potential within the TK1 immunoassay (AroCell) is significantly more far reaching than what is technically possible with TK activity assays (for example Biovica).
Biovica have a well prepared business case, with a focus and foundation in clinical trials in metastatic breast cancer - but that does not change the overall technical fact that the immunoassay (AroCell) have a greater scope of possible areas of implementation.
Just look at the definition of the assays - according to Biovicas FDA clearence the DiviTum assay is defined as a semi-quantitative assay. This is in contrast to AroCell TK 210 ELISA, which is defined as a quantitative assay.
So, what is the difference?
“Qualitative analysis is the detection or identification of the constituent elements in the sample, semiquantitative analysis is the estimation of their approximate concentrations, and quantitative analysis is the accurate determination of their concentrations.”
The above facilitates a broader scope of implementation for the TK1 immunoassay versus TK activity.
On top of that adds the better practicality in the AroCell immunoassay which enables the possibility of easy implementation on different automated systems (like, for example, the Roche Cobas) - and this should likely be a very important factor in the context of broad standardized implementation of TK1 measurements.
Biovica appears ta have a well prepared business case, but in the long run I would say the future of TK1 measurements will be within the immunoassay.
Perhaps there are interesting possibilities if there should be a technical solution that enables the combined measurement, in one single assay, of both TK1 protein (immunoassay) and TK activity.
But this is only personal “theories” - this idea may not be technical possible (allthough the Diasorin TK Liaison measures TK activity through a process that, to me, appears to maybe facilitate a window towards such a combined TK1 assay). But this is just pure amateur speculation.
In the latest forum post yesterday, I made a reference to the FDA clearence of Biovicas DiviTum. Here is a link to that decision summary by the FDA.
Source (Biovica - DiviTum FDA 510k clearence, decision summary, 2022):
When, now once more reading through the decision summary, I realize that I find some of the statistics very confusing. I do not understand the data surrounding the very important Negative Predictive Value (NPV).
The following PM from Biovica highlights the Negative Predicitve Value as a very important statistical parameter in this 510K clearence.
“The DiviTum®TKa approval is based on clinical data from the SWOG S0226 study and a so-called clinical validation study based on SWOG S0226. In the clinical validation study, the assay demonstrated excellent capabilities to identify non progressors with high negative predictive values, NPV, of 96.7% for progression within 30 days and 93.5% for progression within 60 days. This means that 96.7% of patients with DiviTum®TKa measurements below the assay clinical cut-off, did not experience disease progression within the next 30 days.”
Source (Biovica PM):
Ok, so with the importance of the NPV established through the above Biovica PM, now back to the statistics in the FDA decision summary (I am in the following referring to both tables of statistics on page 15 in the following link):
I have two questions.
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1.
The measurements with DiviTum generated a NPV of 96,7%. This value is generated by dividing 888 by 918 (from the figures in the first table on page 15).
Ok… but what NPV would be generated without any measurement at all?? This value is (as I understand) generated by dividing 1101 by 1164 (from the same table as above). And that renders a NPV of 94,5%.
So, apparently… the NPV by using DiviTum is 96,7%. And the NPV by doing nothing at all is 94,5%.
Isn´t that strange? The difference between using DiviTum and by doing nothing seems to actually be very small?? How can this be? This didn´t feel quite right - was there something going on in the statistics?
This led to question nr 2.
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2.
Looking at the study design, it is obvious that the vast majority of patients included in the study did NOT experience progression in the disease. Could this maybe have an impact on the study results?
Could it be that the actual study design, the ratio between progressors and non-progressors included in the study… that such a design parameters could have an impact on the statistics that would than be generated by DiviTum?
Let´s here, for the purpose of investigation, make a very slight change in the initial study design.
Let´s assume that the number of progressors included in the study was slightly higher! From the first table on page 15 we can see that originally there were 63 progressors included in the study. What will happen if we dubbel that number to 126 - but not changing the total number included patients?
Ok, let´s see! If we dubbel progressors to 126, and assume the same capacity by DiviTum to recognize the progressors, than the “figure 30” (for DiviTum less than 250) will change to 60. And, accordingly, the “figure 888” (for DiviTum less than 250) will change to 858.
Ok, so if we now calculate the NEW Negative Predictive Value - which is based on an increased number of progressors relative to non-progregssors - than DiviTum generates the NPV 93,4%.
So, apparently, the generated NPV is totally dependent on the ratio between progressors and non-progressors included in the study! Increasing number of included progressors = declining NPV.
Conclusion: The beforehand generated studydesign will actually have a decisive impact when in comes to determine the NPV that is generated by DiviTum in this particular study.
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So, where do I go wrong? Maybe the SWOG study is meant to mirror the probability of an actual real-life ratio between progressors and non-progressors? That is - statistically only 63 in 1164 patients experience progression in real life… and because of this the, by FDA choosed, studydesign is valid?
No, as an amateur I do not like that explanation, it does not feel right. I would imagine that the ratio between progressors and non-progressors could vary quite substansially between different sets of patient populations?
With some more progressors added to the study design, maybe the NPV could instead have been maybe 89%? Or 87%? Would that had been enough for a FDA clearence?
Of course I am just a simple layman, with no formal statistical education… perhaps someone here at the forum can help in clarifying these questions on the statistics from the SWOG study?
Study in gastric cancer - sTK1p in a panel with two other biomarkers, published today 2022-10-14.
Title: “Clinical Value on Combined Detection of Serum CA724, DKK1, and TK1 in Diagnosis of Gastric Cancer”
Conclusion: “The levels of serum CA724, DKK1, and TK1 were highly expressed in GC patients, with a higher diagnostic value for GC in their combined detection, which can effectively screen and assist the diagnosis of GC.”
Source:
These kind of similar studies, on the usefulness om sTK1p in combination with other biomarkers, seems to, over the years, show up frequently in different cancer indications - here in gastric cancer.
Maybe notable this time is the included reference list, in which the authors give references to two TK1 studies.
The first reference is to one of the latest studies from Bernhard Tribukait, which is based on the AroCell TK 210 ELISA - and included herein are the two patented AroCell monoclonal TK1 antibodies.
Reference number two is also interesting. This is a reference to a recent study from the Kim ONeill TK1 team (Thunder Biotech, Brigham Young University). In this study the ONeill TK1 team confirm that - with respect to detection by antibodies - the most relevant region on the TK1 molecule is exactly the same region that AroCell use as target (this ONeill study is also, by the way, mentioned in the latest PM from AroCell on the recent published analytical and clinical characterization of TK 210 ELISA).
Source (the “team ONeill” study, which confirms the best region as a target on the TK1 molecule):
To sum up - interesting article published today on TK1 in gastric cancer, including references to an external study that positively validate the by AroCell chosed region on the TK1-molecule as the best target. This region is also, as I understand, highlighted in one of the Roche patent applications.
Of course we allready knew that the patented AroCell antibodies were highly competent, but nevertheless it may feel quite positive and reassuring to have the strength and importance of this specific region on the TK1 molecule confirmed also by data from external scientists.
Prediction of overall survival in metastatic prostate cancer patients by using AroCell TK 210 ELISA as a tool - Jagarlamudi Kiran Kumar, Paavo Raittinen, Teuvo Tammela,Teemu Murtola
STK1 concentration and STK1 activity as a diagnostic and prognostic proliferation biomarker for ovarian cancer - Diana Cviič, Joško Osredkar
PrediPet measures TK1 protein and is an efficient serum biomarker for dogs with malignancies - Staffan Eriksson, Hanan Sharif, Kiran Jagarlamudi, Sara Saelstrom, Henrik Ronnberg, Liya Wang, Anne-Charlotte Aronsson
The ISOBM nr1 platinum sponsorship was open for a long time before the event, but apparently Roche did finally sign up for that engagement. Of course this means nothing whatsoever, but I can´t help getting a nice feeling when the powerful Roche logo unexpectedly turns up on top in the link below. Maybe a sign from above…
Arocell vaikuttaa käänne yhtiöltä ja sillä on hyvät lähtökohdat, inflaatiosta ja korkojen noususta huolimatta
Käytännössä velaton yhtiö
Rahaa kassassa
Kulut saatu sopeutettua
Yhteisyrityksen hyödyt näyttäisi toteutuvan
Fuusion tavoitteena on yleensä saada aikaan toiminnoiltaan tehokkaampi ja hallinnoltaan kevyempi yhtiökokonaisuus. Sulautumisen seurauksena on mahdollista hyödyntää paremmin yhtiöiden synergioita, yhtenäistää projekteja ja keventää yritysrakennetta
AroCell jatkaa myynnin kehittämistä Afrikassa. Tänään AroCell on allekirjoittanut jakelijasopimuksen MM African Technologyn kanssa, joka kattaa Sambian ja Malawin. Sopimus kattaa TUBEX® TF:n ja UBC® Rapidin myynnin
AroCellistä on muodostunut kätevä “Tecnotree” lyhytaikaiseen treidaukseen, kun kurssi sahaa lähes viikottain akselilla 0,47 <-> 0,51 eli bauttia 8 % per kierros.
Maybe the newly established compatibility with the cube reader will come in handy and deliver convenience and ease of use, supporting UBC Rapid in clinically demanding settings, like parts of the African market?
About MM Technology: “We will undertake distribution in any country in Africa. We have offices in South Africa, Botswana, Lesotho, Malawi, Namibia, Eswatini, Zambia, Zimbabwe. We have also supplied customers in Burkino Faso, Chad, Senegal, Niger, Cameroon, DRC and other countries.” https://mmafricantech.com/about-us/#NaN
New research article on the UBC Rapid test, which seems to make room for some speculations towards a possible expansion for UBC Rapid into the Asian market. Quotes from the article:
“Thus far, all the clinical evaluations of UBC®Rapid studies completed are in Western population. Given the possible genetic variations of gene KRT8 and gene KRT18 in different ethnic groups, it is essential to expand the evaluation of UBC®Rapid to various human populations.” /…/
“Our study showed good performance of qualitative UBC®Rapid in detecting bladder cancer in Asian population. The sensitivity (53%) and specificity (85.5%) in our study are comparable to those reported in Western population (sensitivity ranging from 46.2% to 78.4% and specificity ranging from 82.4% to 97.4%). Thus, UBC®Rapid may be useful in detecting bladder cancer in Asian population.”
Title of the article: “UBC®Rapid Is Sensitive in Detecting High-Grade Bladder Urothelial Carcinoma and Carcinoma in situ in Asian Population”
Interestingly, the article also comments positively on the technical performance, which appears to indicate that the UBC Rapid test have important advantages compared to the BTA and NMP22 tests (which are two tests that have allready been approved/cleared by the FDA):
“There are some obvious advantages of UBC®Rapid compared to BTA and NMP22 tests. For example, BTA test results are completely unreliable if trace amount of blood (150 erythrocytes/μL) is present in the urine specimen. NMP22 test is significantly less sensitive in detecting bladder cancer than UBC®Rapid (12.9–16.4% vs. 60.7–61.3%) in the head-to-head comparison.”
Edit on the technical performance: as the new version of UBC Rapid (under development) will add an additional cytokeratin marker to be included in the test, this will make the performance of UBC Rapid even stronger.
