Sex hormones (estrogens in females and androgens in males) are integral to health and well-being, playing major physiological roles in the normal functioning of the nervous system, musculoskeletal system, digestive system, cardiovascular system, immune system, and metabolism.

Consumer sports supplements can harbour androgens and estrogens, either intentionally or unintentionally. Non-intentional contamination of sports supplements is possible through manufacturing and storage processes, contaminated raw materials, or through the use of raw material with unexpected phyto-androgen or estrogen content. The deliberate addition of androgenic or estrogenic compounds to sports supplements is an ongoing issue for all consumers, particularly elite athletes who may unknowingly consume banned substances or designer androgens.

The constant intake of additional androgens or estrogens can disrupt normal endocrine balance in the body, resulting in a number of serious health outcomes or adverse drug-drug interactions.

The unknown ingestion of anabolic-androgenic steroids can impact a number of vital organ systems, including the liver (cholestasis), kidneys (renal failure) circulatory system (hypertension, polycythemia), skin (acne), and can result in psychological dependence. Ingestion by women can lead to disrupted menses, develop characteristics associated with male hormones, alopecia, among other severe consequences.

The increasing use of unregulated dietary supplements put athletes at a continued risk of those adverse medical events and can also result in competition bans for illegal substance use.

A growing awareness of steroid contamination by consumers at all levels of sport has increased the need for mitigation strategies from manufacturers, including producing third-party certified products. Third-party testing often relies on known chemistry to identify individual substances.

The dietary supplement industry in the USA is a USD38.8 billion industry, with more than 85,000 supplements marketed as of 2015. The use of dietary supplements is up to 94% among elite athletes , and up to 53% of American adults.

InsituGen has developed a suite of rapid and cost-effective tests to report on total estrogenic and androgenic activity in supplements. FirstFlagX will provide manufacturers and consumers with an assurance that processes and products are hormone-free.

FirstFlagX combines the biological power of traditional bioassays with the speed and polish of synthetic biology, and revolutionises the detection of any androgenic or estrogenic compound following a simple extraction process in sports supplements. FirstFlagX can detect any androgen and estrogen compound, including designer steroids undetectable by current chemical analysis measures.

<pFirstFlagX permits manufacturers an additional measure of quality control, including the ability to screen each batch of a product for unintentional contamination resulting from production processes or contaminated supplier raw material. Manufacturers can include the FirstFlagX logo on products to increase trust in processes and ingredients being steroid-free.