Precisely seven years ago it was possible to consider Epigenomics and Exact Sciences alongside one another, as two companies heading to the US FDA with colorectal cancer tests whose clinical data showed them to be less accurate than the cheaper standard of care. Over the following years, however, their fortunes have diverged sharply. Aided by progressively larger acquisitions, Exact is now a top-10 diagnostics company making strides in everything from precision medicine to pan-cancer liquid biopsy, while Epigenomics today admitted that it had come to the end of the road and put itself up for sale. The German group blamed the Centers for Medicare & Medicaid Services’ refusal, in October 2020, to reimburse its Epi proColon blood test. An earlier attempt by the Chinese private equity firm Cathay Fortune to take the group private floundered in August 2017 after failing to gain enough support from Epigenomics’ shareholders. Perhaps this time those investors will admit that the company has no real future as an independent concern.
| The contrasting fates of two colorectal cancer test developers | ||
|---|---|---|
| Company | Exact Sciences | Epigenomics |
| Test name | Cologuard | Epi ProColon |
| Pivotal trial sensitivity | 92% | 71% |
| Pivotal trial specificity | 87% | 81% |
| Adcom date | March 27, 2014 | March 26, 2014 |
| Adcom risk-benefit vote | 10 to 0 in favour | 5 to 4 in favour |
| US approval date | August 11, 2014 | April 12, 2016; had been rejected twice |
| Current market cap | $22.0bn | $17.6m |
| Forecast 2026 test revenues | $3.5bn | $58m |
| Source: EvaluateMedTech, FDA & company releases. | ||
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