Exact eyes 2020 launch for liver cancer liquid biopsy

Exact Sciences has recently been attempting to diversify away from its core stool test for colorectal cancer, which has been selling well but has so far been unable to lift the company out of loss-making territory. Today’s top-line data on one of these new programmes, the group’s hepatocellular carcinoma blood test, shows that when specificity was set at 90%, Exact’s test detected 80% of HCC cases across all stages and 71% of early stage cases. This was better performance than the most commonly used marker for HCC, serum alpha-fetoprotein (AFP). AFP testing is falling out of favour as an HCC diagnostic as imaging techniques improve and are beginning to take its place; indeed guidelines recommend ultrasound is used to screen at-risk patients, with AFP as an optional extra. Exact says that ultrasound plus AFP has demonstrated 63% sensitivity for early stage cancers, so its test would beat that, but whether the difference is significant enough for payers to back the new assay is as yet unclear. Exact plans to launch the test in the second half of 2020, but out to 2024, analysts do not see the company earning money from anything other than Cologuard.

Top-line data with Exact's HCC liquid biopsy
  All cancers Early-stage disease
  Sensitivity Specificity Sensitivity Specificity
Exact's test 80% 90% 71% 90%
AFP testing 62% - 45% 90%
Ultrasound + AFP - - 63% -
Exact Sciences
  WW annual sales ($m)  
Segment  2019e 2020e 2021e 2022e 2023e 2024e CAGR
Cologuard/laboratory service revenue  748 1,101 1,595 2,021 2,465 2,908 31%
Total company revenues 748 1,101 1,595 2,021 2,465 2,908 31%
Source: EvaluateMedTech. 

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