Redhot diagnostics AB is a company that produces, market and sell diagnostic products to research and routine laboratories at hospitals. Using our patent-pending rhelise™ kit, we are enabling diagnostic testing and therapeutic drug monitoring of patients in their home environment.

Phosphatidylethanol (PETH)

Phosphatidylethanol (PEth) is a generic term for a large group of phospholipids formed from the cell membrane molecule phosphatidylcholine in the presence of ethanol, making them 100% specific for ethanol. Due to the relatively slow elimination, PEth´s half-life is about 5 days. PEth is generally accepted as the best biomarkers for ethanol consumption and correlated to alcohol consumption over time. Despite years of practis, no false positives have been reported in humans.

Principles of the Method

Phosphatidylethanol is extracted from whole blood by addition extraction solvent containing an internal standard to the sample. After mixing and centrifugation the supernatant is injected in the LC-MS/MS system, where components are separated on a reversed phase (C8) column using a binary gradient.
redhot diagnostics utilize proprietary technology for the production of PEth Calibrators and a D5-PEth internal standards. Patent EPO 2993434, US 9499572 and 9784701

CE-IVD label ( according to European Directive 98/79/EC)

Tamoxifen

Tamoxifen is the most widely prescribed cancer drug worldwide for women with early-stage estrogen receptor positive (ER+), HER2-negative breast cancer. After finishing their treatment for the cancer, they are prescribed tamoxifen to prevent relapse. A 5- to 10-year treatment delays local and distant recurrence, prolongs overall survival, and reduces the incidence of contralateral breast cancer.
The standard dose of tamoxifen, 20 mg/day, is given to all women independent their BMI, inter-individual variation, liver disease and other drugs. This could either lead to overdose, causing side effects or too low dose. According to several studies, Tamoxifen adherence to therapy may be as low as 50%, because many women suffer from severe side effects and discontinue medication. Poor adherence and early discontinuation are both associated with an increased risk of breast cancer recurrence.

Therapeutic Drug Monitoring

An individualized prescription based on the actual concentrations of the drug and its primary metabolites in the blood would increase the possibility of receiving optimal treatment, reduce the side effects and enhance quality of life. However, the conventional method of tamoxifen therapeutic drug monitoring is complicated and expensive, and therefore not widely used.

redhot’s rhelise™ kit and the tamoxifen analysis kit are ideally suited for therapeutic drug monitoring and developed to provide women under tamoxifen treatment with an easy to use at-home test and the analysis lab with a straightforward and robust method for LC-MS/MS quantitative determination of tamoxifen, Z-endoxifen and 4–hydroxy tamoxifen in whole blood.

Methylmalonic Acid (MMA)

Vitamin B12 is only synthesized by microorganisms in nature and thus, is obtained by human beings through their dietraff. Since the most important source of vitamin B12 is animal proteins, vegetarians may lack sufficient quantities of this vitamin in their diets.

Vitamin B12 deficiency is one of the most frequent vitamin deficiencies worldwide. So, this deficiency is an extremely important public health issue owing to its serious complications if it is not detected and treated appropriately. It is now considered to be a problem of global dimensions, frequently caused by dietary inadequacy, particularly among children and in women of reproductive age.

Numerous studies have now established that serum vitamin B12 has limited diagnostic value as a stand-alone marker. Low serum levels of vitamin B12 not always represent deficiency, and likewise, severe functional deficiency of the micronutrient has been documented in the presence of normal and even high levels of serum vitamin B12 [2].
Methylmalonic acid thus considered to be a more specific marker of vitamin B12 deficiency. Serum values of MMA, ranging from >0.26 to 0.35 μmol/L indicate elevation of this metabolite.

Rhelise kit for monitoring of Pharmaceuticals levels in cancer patients

Redhot diagnostics has developed the rhelise® kit, that makes it possible to take a capillary sample from a lancet stick in the finger. The kit initially developed for phosphatidylethanol (PEth), which is a biomarker for long term alcohol intake.
The Ethics Examination Board and the Medical Products Agency have given consent to validate the rhelise® kit within the current clinical study TailorDose-II at Karolinska Institutet / NKS Solna.
The pharmaceuticals studied are Cyclophosphamide, Epirubicin, Doxorubicn, Decetaxel and Paclitaxel. The study is made to show that individualized dose adjustment of chemotherapy against breast cancer is better than current practice, body-based dosage. The initial study performed will be to compare venous and capillary blood samples.
About redhot diagnostics AB:

Redhot diagnostics AB is company with focus on developing the next generation of analytical kits for LC-MS/MS platforms.
The LC-MS/MS platform is now moving from the research environment to the clinic routine lab settings. With that follows that the methods used for different biomarkers has to be standardized in a way that makes them easy to use in routine labs and with preserved quality.
The introduction of complete LC-MS/MS kits for different established biomarkers is today a relatively unexplored business market.

New capillary sampling kit for the determination of Tamoxifen in blood has been financed by Vinnova

Together with the company Adduct Analys AB, redhot diagnostics has been financed from Vinnova to develop a cost-effective, easy-to-use, non-invasive capillary sampling kit for dose monitoring of Tamoxifen. Capillary sampling would allow a layman to take the test with simple instructions and the patient would not have to go to primary care for the help of a nurse or other trained staff.
Therapeutic drug monitoring (TDM) analysis is a prerequisite for individual drug treatment. The purpose of TDM is to improve the individual benefit of treatment and reduce the number of patients at risk of insufficient clinical effect, or side effects due to excessive concentrations. Although there are major individual differences in the way drugs are metabolized in different patients, routine TDM is used for relatively few drugs in health care. Today there are no monitoring of Tamoxifen at all. A standard dose is given to all patients and they are expected to continue this medication for a recommended period of 5 to 10 years. Many patients experience side-effects due to too high does, 20 % of the patients is getting a to low dose and about 50% of the patients self-interrupt their treatment.
There are about 500 000 women in Europe that are under treatment by Tamoxifen. By creating self-sampling options, we facilitate for the patient to take a sample, reduce load on primary health care units and reduce costs. Patients in sparsely populated regions gives an easier access to a good health care. It will become health-economical gains from more effective healthcare.

Redhot diagnostics AB in brief.

Redhot diagnostics is a diagnostic company with a unique business structure that takes ideas / prototypes from academic research to product to market. This is done through completed processes in a thoughtful, fast and cost-effective way. This concept gives the academic researcher a unique way to easily reach the market with its product idea.

Adduct Analys AB in brief.

The company shall conduct research, development and application of methods for analysis of electrophilic substances.
Vinnova in brief is Sweden’s government agency for innovation. Our mission is to contribute to sustainable growth by improving the conditions for innovation. We do this mainly by funding innovation projects and the research needed to develop new solutions. We also invest long term in strong research and innovation environments.

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