Hikma Pharmaceuticals PLC has welcomed the recent approval by the U.S. Food and Drug Administration (FDA) of Guardant360 Liquid CDx, the largest FDA-approved liquid biopsy panel developed by Guardant Health. The milestone was highlighted during the 5th Annual International Oncology Forum (IOF) 2026 held in the UAE, where both Hikma and Guardant Health participated as platinum sponsors.

Guardant360 Liquid CDx is an advanced liquid biopsy test that enables comprehensive cancer biomarker testing using a simple blood sample, offering a less invasive alternative to traditional tissue-based testing methods. The test is powered by Guardant Health’s proprietary Smart Platform, which combines genomic and epigenomic profiling from a single blood draw to provide clinicians with deeper insights into tumour biology.

The newly approved platform analyses tumour DNA mutations and helps physicians make more informed treatment decisions for patients with advanced cancers originating from solid organs. According to the company, the test provides a genomic footprint that is 100 times broader and significantly enhances sensitivity for detecting circulating tumour DNA (ctDNA) compared to the previous Guardant360 CDx platform.

With the FDA approval, all seven previously approved companion diagnostic indications associated with Guardant360 CDx have been transferred to Guardant360 Liquid CDx, further expanding its clinical utility.

Hikma and Guardant Health entered into an exclusive agreement in 2024 for the commercialisation and marketing of Guardant’s liquid and tissue biopsy solutions across the Middle East and North Africa (MENA). The partnership covers cancer screening, recurrence monitoring and tumour mutation profiling across a wide range of solid tumours.

Commenting on the development, Mazen Darwazeh, Executive Vice Chairman and Deputy CEO – MENA at Hikma, said the approval marks an important advancement in bringing next-generation diagnostic technologies to the region. He noted that the enhanced molecular profiling capabilities of Guardant360 Liquid CDx can help clinicians gain a deeper understanding of tumour characteristics and support precision treatment strategies for cancer patients.

Simranjit Singh, Chief Executive Officer of Guardant Health AMEA, said the approval reinforces the company’s leadership in precision oncology, highlighting that Guardant is the only precision oncology company with three FDA-approved solutions spanning the cancer care continuum. He added that the company’s Smart Platform provides clinicians with comprehensive molecular insights that can support treatment selection and improve outcomes in advanced cancer care.

One of the key advantages of Guardant360 Liquid CDx is its rapid turnaround time, with results available in as little as seven days after sample receipt. The test is approved as a companion diagnostic for multiple cancer types, including non-small cell lung cancer, colorectal cancer and advanced breast cancer, delivering detailed tumour profiling regardless of tissue availability or treatment stage.

The approval is expected to further strengthen access to precision oncology solutions across the MENA region, supporting more personalised and timely cancer care for patients.