Free testosterone is the biologically active form of the hormone in the body. Image credit: Shutterstock / Irina Anosova.

The US Food and Drug Administration (FDA) has cleared Revvity’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone.

The authorisation by the agency marks the first time a ChLIA has been cleared to quantitively measure free testosterone levels directly, according to Revvity.

Shares in the NYSE-listed company opened 2% down at market open compared to a pre-announcement market close. Revvity has a market cap of $14bn.

Available through Revvity’s medical laboratory diagnostic business EUROIMMUN, the test produces results in 48 minutes and can process nearly 60 tests an hour. Along with the high throughput testing and quick turnaround times, minimal technician training and expertise are required.

Free testosterone is the biologically active form of the hormone in the body. Accounting for around 2%-5% of all testosterone in the body, it can bind to receptors because it is not attached to any proteins already. Equilibrium dialysis is considered the gold standard technique for measuring free testosterone.

Revvity’s test measures free testosterone levels from human serum or plasma via a single test. Its use includes improving diagnostic capabilities for testosterone-based diseases such as hypogonadism, impotence, and polycystic ovarian syndrome (PCOS).

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“Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone,” said Jonathan Friend, general manager at Revvity’s EUROIMMUN US.

“This clearance reinforces our commitment to expanding the FDA-cleared menu for the EUROIMMUN family of ChLIA automation solutions with assays that serve diverse patient populations across all demographics.”

ChLIA, a variation of the standard enzyme immunoassay, utilise photon emission during substrate reaction to identify peptides, hormones and proteins in a fluid sample.

Revvity reported full-year 2023 revenues of $1.5bn for its diagnostics segment, down from $2bn in 2022.

In October, EUROIMMUN launched the in-vitro diagnostic EURORealTime TM APOE assay, a test that genotypes the APOE gene. APOE genotyping is important before starting therapy in Alzheimer’s disease patients.

The in vitro diagnostics market was estimated to be worth $33.8bn in 2023, with it forecast to grow to $33.5bn by 2033, as per analysis by GlobalData. The testosterone lab test market was worth around $22m in 2023 and is expected to grow to $26m by 2033.