Invitrogen test gets FDA approval

Invitrogen has received pre-market approval from the US Food and Drug Administration (FDA) for its new breast cancer test.

The life science technologies firm announced yesterday (July 8th) it had received the FDA’s approval for its Spot-Light HER2 CISH kit as an aid in the assessment of breast cancer patients where trastuzumab Herceptin treatment is being considered.

Greg Lucier, the firm’s chairman and chief executive officer, said the introduction of the test was an example of how the organisation’s technologies can be used in a clinical setting to have a "direct impact" on healthcare.

The kit is based on a technology called chromogenic in situ hybridisation and uses a DNA probe for the HER2 gene that is amplified in 18 to 30 per cent of breast cancers and forecasts whether the patient is suitable for trastuzumab treatment.

"The FDA’s approval of this kit for the US market also demonstrates our ability to apply Invitrogen technologies into high-growth applied markets," Mr Lucier added.

Harrison Ford and Dr Edward Wilson joined the company as it launched a new programme to distribute grants to advance science literacy last month.