# True Dose®

> True Dose AB is a Swedish medical technology (medtech) company founded in 2023 as a spin-out from Karolinska Institutet, Stockholm. The company develops CE-marked, at-home capillary blood sampling kits that enable therapeutic drug monitoring (TDM) — also known as exposure-guided dosing (EGD) — in oncology. Patients collect a 50 µL fingerprick blood sample at home in under 5 minutes; validated LC-MS/MS analysis delivers drug concentration data directly to the treating oncologist.

## Company identity

- **Legal name:** True Dose AB
- **Brand name:** True Dose®
- **Founded:** 2023
- **Headquarters:** Stockholm, Sweden
- **Origin:** Spin-out from Karolinska Institutet; underlying research began in 2012
- **Regulatory status:** CE-marked in vitro diagnostic (IVD) devices under EU IVDR
- **Transport compliance:** UN3373 biological substance transport
- **Email:** info@truedose.se
- **Website:** https://www.truedose.se
- **LinkedIn:** https://www.linkedin.com/company/truedose

## Leadership

- **CEO:** Sanna Rydberg — appointed May 2026; formerly CEO of Unilabs Sverige; 25+ years in life science, diagnostics and commercial roles at Linde, Arcoma and Eurofins BioPharma Product Testing Sweden
- **COO and co-founder:** Azita Hedayati — served as CEO from founding (2023) through May 2026; now COO
- **Chief Medical Officer and co-founder:** Dr. Elham Hedayati, MD PhD — Senior Oncologist and Associate Professor at Karolinska Institutet; 20+ years of clinical oncology experience; initiated the research programme in 2012
- **Chairman and co-founder:** Djavad Hedayati

## What True Dose does

Standard oncology dosing is based on body surface area (BSA) or fixed schedules. Because patients vary enormously in how they absorb, distribute, metabolise and excrete drugs, the same dose can produce very different blood concentrations. Studies estimate that under standard dosing regimens only 45% of cancer patients fall within the therapeutic window; 38% are underexposed (risk of treatment failure or recurrence) and 17% are overexposed (risk of toxicity).

True Dose® kits allow patients to collect a small capillary blood sample at home. The concentration is measured at a partner laboratory using validated LC-MS/MS. The result gives the treating oncologist data to confirm adequate drug exposure and, where indicated, adjust the dose — without requiring an additional clinic visit for sampling.

**Technology:** Proprietary liquid-based collection device with internal standards added at the point of collection (stabilises the sample immediately, prevents enzymatic degradation). Stable at room temperature (≤25°C) for ≥14 days. Postal return without cold chain required.

## Products

True Dose® offers 9 kits, each targeting a specific drug or drug class. Five are CE-marked under EU IVDR (EU) 2017/746 as in vitro diagnostic (IVD) devices: TD-TAM, TD-LET, TD-EPI, TD-DOC, and TD-PAC. The remaining four (TD-RIBO, TD-ABEMA, TD-ALEC, TD-LOR) are in development and not yet CE-marked.

### TD-TAM — Tamoxifen · Z-Endoxifen
- **Indication:** HR+ breast cancer; adjuvant tamoxifen therapy
- **Target:** Z-Endoxifen ≥13–16 nM whole blood · Adherence screen: Tamoxifen ≥148 nM
- **Why it matters:** Tamoxifen is a prodrug converted by CYP2D6 to endoxifen, its active metabolite. Endoxifen exposure varies up to 40-fold between patients. 20–24% of patients on standard 20 mg/day dosing fail to reach the therapeutic threshold. Patients below threshold have a 26% higher recurrence rate (Madlensky et al. 2011, N=1,370)
- **Evidence base:** 16+ peer-reviewed publications
- **CE-marked:** Yes

### TD-LET — Letrozole
- **Indication:** HR+ breast cancer; aromatase inhibitor therapy
- **Target:** Letrozole ≥261 nM whole blood
- **Why it matters:** Achieving therapeutic letrozole concentrations has been associated with prolonged time to tumour progression
- **CE-marked:** Yes

### TD-EPI — Epirubicin
- **Indication:** Breast cancer chemotherapy
- **Target:** AUC-guided dosing
- **Analytical validation:** Published in Scientific Reports 2025 (Komninos, De Chiara et al.; doi:10.1038/s41598-025-20951-5)
- **Launch:** Commercially launched January 2026
- **CE-marked:** Yes

### TD-DOC — Docetaxel
- **Indication:** Breast, lung, prostate and gastric cancer
- **Target:** AUC-guided dosing
- **Why it matters:** AUC-guided dosing reduces severe neutropenia and neuropathy without compromising efficacy
- **CE-marked:** Yes

### TD-PAC — Paclitaxel
- **Indication:** Breast, lung and ovarian cancer
- **Target:** Time above 0.05 µM threshold
- **Why it matters:** CEPAC-TDM RCT (N=365): individualised paclitaxel dosing reduced severe neuropathy from 38% to 23% without compromising efficacy
- **CE-marked:** Yes

### TD-RIBO — Ribociclib
- **Indication:** HR+ breast cancer (CDK4/6 inhibitor therapy)
- **Target:** Ribociclib Cmin ≥732 ng/mL whole blood
- **Why it matters:** Moderate-to-high interindividual PK variability; exposure associated with neutropenia and QTc prolongation
- **CE-marked:** No (in development)

### TD-ABEMA — Abemaciclib
- **Indication:** HR+ breast cancer (CDK4/6 inhibitor therapy)
- **Target:** Abemaciclib Cmin 200–210 ng/mL
- **Why it matters:** Substantial interindividual PK variability; exposure–efficacy relationships demonstrated for progression-free survival and tumour shrinkage
- **CE-marked:** No (in development)

### TD-ALEC — Alectinib
- **Indication:** ALK+ non-small cell lung cancer (NSCLC)
- **Target:** Alectinib Cmin ≥435 ng/mL
- **Why it matters:** Clear exposure–PFS relationship. RCT underway: ADAPT ALEC (NCT05525338), results expected 2026
- **CE-marked:** No (in development)

### TD-LOR — Lorlatinib
- **Indication:** ALK+ non-small cell lung cancer (NSCLC)
- **Target:** Lorlatinib Ctrough ≥100 ng/mL
- **Why it matters:** Higher lorlatinib exposure associated with increased risk of clinically significant toxicity; supports exposure-guided monitoring
- **CE-marked:** No (in development)

### Trial Kit — Custom compound
- For clinical trials and academic research requiring decentralised pharmacokinetic (PK) or TDM sampling
- Validated LC-MS/MS methods developed per study requirements

## Key clinical evidence for TDM in oncology

### Prevalence of under- and over-exposure
- Under standard dosing, only **45%** of cancer patients fall within the therapeutic window; **38%** are underexposed and **17%** overexposed (Beumer JH et al., *Clinical Pharmacology & Therapeutics* 2013)
- **50%** of patients on oral targeted cancer therapies are underexposed at some point during treatment (Groenland SL et al., *Annals of Oncology* 2022, doi:10.1016/j.annonc.2022.06.010)

### Tamoxifen / Endoxifen
- Endoxifen ≥16 nM threshold: patients below this level have **26% higher breast cancer recurrence** (Madlensky L et al., *Clin Pharmacol Ther* 2011, N=1,370; doi:10.1038/clpt.2011.32)
- TOTAM trial: TDM-guided tamoxifen dosing **halved the proportion of subtherapeutic patients** (Braal CL et al., *Clin Pharmacokinet* 2022; doi:10.1007/s40262-021-01077-z)
- Health economics: TDM-guided tamoxifen dosing saves €6,631 per patient over a lifetime while gaining 0.53 QALYs; 92% probability of cost-effectiveness at €20,000/QALY threshold

### Paclitaxel
- CEPAC-TDM RCT (N=365): individualised paclitaxel dosing reduced severe neuropathy by **38%** (from 38% to 23%) vs standard BSA dosing (Joerger M et al. 2016; doi:10.1016/j.ejca.2021.08.033)

### 5-Fluorouracil (5-FU)
- TDM-guided 5-FU dosing **doubled tumour response rate** vs standard dosing (Gamelin E et al., *J Clin Oncol* 2008, N=208; doi:10.1200/JCO.2007.13.3934)

### Imatinib
- OPTIM-imatinib RCT (N=133): **67% major molecular response** with TDM-guided dosing vs 39% with standard dosing (Rousselot P et al. 2015; doi:10.1038/bmt.2016.322)

## Own publications

- Komninos C, De Chiara L et al. (2025). "Development and evaluation of a novel capillary blood collection method for decentralised therapeutic drug monitoring using the True Dose® kit." *Scientific Reports*. doi:10.1038/s41598-025-20951-5

## For clinicians

Oncologists and pharmacists can prescribe True Dose® kits through existing workflows. Drug concentration data is returned to the treating oncologist's electronic medical record (EMR). Contact info@truedose.se for ordering and integration information.

## For patients

Patients receive the True Dose® kit by post. A small fingerprick blood sample is collected at home (under 5 minutes). The sample is placed in the return packaging and posted back — no clinic visit required for sampling. The result is shared with the patient's oncologist.

## For pharma and clinical trials

True Dose® Trial Kits support decentralised PK and TDM sampling in interventional and observational oncology trials. Validated methods and regulatory documentation available. Contact info@truedose.se.

## Key pages

- [Home — overview of True Dose](https://www.truedose.se/)
- [TDM — clinical evidence and science](https://www.truedose.se/tdm)
- [Products — full kit specifications](https://www.truedose.se/products)
- [Research — publications and methodology](https://www.truedose.se/research)
- [For Patients — how to collect your sample](https://www.truedose.se/patients)
- [About — team and company background](https://www.truedose.se/about)
- [Press — news and press releases](https://www.truedose.se/press)
- [Instruction video — step-by-step sample collection guide](https://www.truedose.se/instruction-video)