Test 'protects patients from falsified growth hormone'

UK company Eluceda says it has developed a quick and accurate test solution for identifying counterfeit human growth hormone (hGH) without the need for centralised testing infrastructure.

The detection technology specialist claims that existing drug authentication methods tend to rely on specialist, expensive, and centralised equipment with samples often having to travel across borders, leading to lengthy waits on test results.

Its approach allows testing to be carried out in the field, for example by enforcement personnel, customs officials and medical professionals.

hGH – also known as somatropin – is used to treat growth hormone deficiency, a range of rare conditions including Turner and Prader-Willi syndrome, and chronic renal insufficiency. Use of the drug as a body-building or anti-ageing agent has created a thriving black market however, often sourced via the Internet, encouraging product diversion and counterfeits to enter the market.

The legitimate market for somatropin was worth almost $4bn worldwide in 2020, according to market research company Coherent, and is expected to reach $9bn by 2030.

At best, counterfeit drugs may contain the active pharmaceutical ingredient (API) but generally this is not the case, says Eluceda.

Normally, to increase profits, counterfeiters use a lower dose of material, a different API or none at all. The fakes are generally made in non-sterile conditions without any adherence to manufacturing regulations, raising the risk of health complications if used. That’s a particular concern for drugs like somatropic that are administered by injection.

Eluceda’s test takes the form of a reader connected to a mobile phone, tablet or PC. A small drop of the test liquid is placed onto a disposable sensor which can detect small variations in electrochemical signal, such as might be caused by dilution or contaminants.

The E-Sens reader is accompanied by software that uploads test results to the cloud for access by authorised people, and records additional information like the time, date and geolocation of a sample, creating a database that can be analysed for example to spot hot-spots of counterfeiting in the market.

“Counterfeit drugs are an increasing public health issue as people look to buy medicines online,” said Dr Ian Eastwood, Eluceda’s chief technology officer.

“Somatropin is just one of many and by ensuring the products are genuine through our easy-to-use authentication technology we can help maintain confidence and protect the health of people worldwide.”

In 2017, falsified copies of a generic somatropin product made by Sandoz were discovered in the supply chains of France, Denmark and Mexico.