California-based molecular diagnostics company MiraDx has added Prostox Standard to its portfolio – marking another US launch in the company’s cancer testing portfolio.
The diagnostic assay is designed to guide radiotherapy-based treatment decisions in prostate cancer by uncovering a patient’s risk of developing late genitourinary (GU) toxicity, which is estimated to impact more than 20% of prostate patients receiving radiotherapy.
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This technology could offer physicians the opportunity to provide patients with personalised treatment options at a reduced risk of prompting side effects, while allowing patients to make more informed decisions, Melissa Stoppler, executive VP of medical affairs at MiraDx, tells Medical Device Network.
“The choice between surgery and radiotherapy is often made between patients and their doctors. However, if they are interested in radiotherapy, there has not been, to date, any way to predict whether or not you at high risk of having toxicity from that treatment,” Stoppler said.
Prostox Standard aims to address this treatment gap by revealing if specific types of radiation, including conventionally fractionated or moderately hypofractionated radiation therapy (CFRT, MHFRT), will place a patient at high risk of developing treatment-emergent GU issues in the long term through a sample obtained from a cheek swab.
The test evaluates unique, inherited biomarkers in micro RNAs (miRNA) and their pathways, which play a key role in regulating biological processes through their ability to alter gene expression. As these miRNA signatures differ depending on the dose and type of radiation delivered to the patient, the test can help identify if a specific radiotherapy regimen will put a patient at higher risk of long-term, treatment-emergent toxicity.
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By GlobalDataProstox Standard’s US launch complements the recent debut of MiraDx’s Prostox Ultra test, which reached the market in October 2025 and is designed to evaluate a patient’s risk of developing GU complications after receiving stereotactic body radiation therapy (SBRT).
Considering toxicity risk in cancer treatment
As more effective cancer treatments make it to market, patient and physician focus has shifted to consider both improved survival and patient quality of life. This paradigm change has prompted the medtech industry to explore new ways to reduce treatment toxicity and improve long-term outcomes.
Within the diagnostics realm, companies are now creating everything from companion diagnostic (CDx) assays, which help determine if a patient will benefit from a certain type of treatment to pharmacogenomic (PGx) tests, which characterise how a patient may respond to treatment based on their genetic profile.
According to Stoppler, the miRNA-based assay approach is beneficial in oncology, as the biomarker is “personalised and easy to measure with very little risk of sample failure”.
To further explore the potential of its portfolio, MiraDx is running tests on similar diagnostic tools in other indications – including head & neck, breast and rectal cancer.
A report from GlobalData forecasts that the cancer diagnostics market will reach a value of $3.1bn in 2030.
