Exact Sciences' blood-based liquid biopsy test shows promise in early liver cancer detection: study

Exact Sciences announced Friday that study data presented at the annual meeting for the American Association for the Study of Liver Diseases (AASLD) show that a combination of six blood-based biomarkers outperformed an existing tumour marker test at detecting early-stage hepatocellular carcinoma (HCC). "A more sensitive and convenient blood-based test could help catch the disease earlier," remarked CEO Kevin Conroy, adding "we are encouraged by the data...as it shows an important advancement over the options currently available." The company also said the FDA has granted the HCC test a breakthrough device designation. 

In the study, researchers analysed blood samples from 135 patients with HCC and 308 controls with benign liver disease but no structurally apparent HCC. The accuracy of Exact Sciences' test was compared to the alpha-fetoprotein (AFP) blood test alone for all Barcelona Clinic Liver Cancer (BCLC) stages and for early-stage HCC.

With specificity set at 90%, results showed that the company's combination of four methylated DNA markers and two protein markers detected 80% of HCC cases across all stages, while the AFP test identified 62% of cancers. For early-stage HCC, the six-marker panel demonstrated 71% sensitivity, while the AFP test detected 45% of such cases.

Exact Sciences noted that current guidelines recommend that patients at risk for HCC undergo testing every six months using ultrasound, with or without the AFP blood test. However, while combined ultrasound and AFP testing have demonstrated 63% sensitivity for early-stage cancers, the company noted that nearly half of Medicare patients tested for HCC receive only the AFP test. It also said fewer than one-third of patients adhere to current guidelines.

Meanwhile, Exact Sciences indicated that it is finalising its HCC test development and plans to make the test available in the second half of 2020. "This will help generate real-world evidence to support guideline inclusion, broad reimbursement, and adoption of the test over time," the company added.

Separately on Friday, Exact Sciences announced that it completed its $2.8-billion merger with Genomic Health. 

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