I haven’t started any threads yet, so I hope this first attempt is at least passable.
Arocell Ab is a company focused on developing methods/tests to monitor various tumors, e.g., breast cancer and hematological tumors. The company develops, manufactures, and sells the TK210 Elisa test, which can easily test TK1 protein levels from blood, and the test is more accurate than competitors’ products.
Studies have shown that the levels of this protein rise when tumor-related changes have occurred in the blood/body. With the help of this protein, tumors have been detected even before the onset of clinical symptoms, and thus treatment can be started earlier.
Yesterday, information was released that the Arocell TK210 Elisa test is making a “breakthrough” into the US market in a broader scheme. Previously, the test was sold only for research use, but with FDA approval, it would gain access to the IVD markets, which are significantly larger than the previous niche.
Hopefully, this sheds some light on the company’s operations and is helpful to anyone interested in the matter
AroCell AB (publ) announced today that a 510(k) application has been submitted to the U.S. Food and Drug Administration (FDA) for their AroCell TK 210 ELISA kit.
An introduction to the US market through 510(k) clearance of the AroCell TK 210 ELISA is in line with the company’s previously communicated strategy for expansion in the USA. Today’s submission confirms that the plan for 510(k) clearance of AroCell TK 210 ELISA by the end of 2021 applies.
The last sentence draws attention, it takes 2 years to get through FDA evaluation, if it even gets through?
Yes, this still has a long way to go and is more of a risky investment than a sure thing. However, I personally like to take risks and see what the future brings.
I read studies online that reviewed TK1 tests and “compared” them with each other. Arocell TK210 Elisa was significantly more sensitive in detecting the protein in blood compared to competitors’ products.
The discussion about Avanza has been so active and positive that I went ahead and ordered this with the thought: if it grows, then it earned a really nice bonus, or then I didn’t lose any terrible amounts.
Let’s see until the end of 2021 unless it takes off earlier
Generally speaking, the company’s product should be quite competitive, and there’s certainly demand for the test, considering the prevalence of cancers/tumors nowadays.
Edit: I also read through the discussions on Avanza, and admittedly, there’s quite a positive buzz about this company there
The article mentions that “AroCell submitted an application to the U.S. Food and Drug Administration (FDA) for its product AroCell TK 210 ELISA on Tuesday. Therefore, it may be the first thymidine kinase 1 (TK1) measurement approved for clinical use in the treatment of cancer patients in the United States.”
Yeah, so that was known. I suspect whether interest in the company has somehow increased due to that article, or whatever has raised it. Try to figure out what’s bothering those stocks at any given time
Yes, I would believe the same or at least in the coming years, because all signs point to good development. In addition to this, cooperation with Hoffmann-La Roche.
Nice almost +6% jump right from the morning The Swedish news agency promises a 2 kr value already today. Not far off. I might not change my own plans yet, but the value has indeed risen +19.7% for me.
"Well, there’s been ‘a little’ mess-up in their communication. The FDA approval is expected by the end of 2020, not 2021 as previously mentioned If I understood correctly, the original plan was to submit the FDA application at the end of 2020, but it has already been submitted. So, marketing authorization could be as early as Q1 2021, if the FDA approves.
In Avanza discussions, it’s mentioned that RedEye’s target for the share is currently 2.7 kr (current price 2.01 kr) and that it could reach as high as 10 kr in the longer term. Short term, it could go around 4 kr.
