Precede Bio’s liquid biopsy approach can measure epigenetic changes in cancer cells using just 1mL of plasma. Credit: Catalin Rusnac via Getty Images.

Precede Biosciences has announced positive results for its novel liquid biopsy assay, which can classify human epidermal growth factor receptor 2 (HER2) status in multiple cancers and predict oestrogen receptor (ER) status, as well as ER pathway activity in breast cancer. 

The results were presented during the ongoing American Society of Clinical Oncology (ASCO) annual meeting taking place in Chicago until 4 June. 

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The company presented two posters, the first demonstrating that HER2 status was accurately assessed in 172 patients with advanced breast, gastroesophageal, and ovarian cancers. The second showed that ER status was accurately assessed, and the level of ER pathway activation was quantified in 87 patients with advanced breast cancer. 

While other cancer blood tests have focused on identifying individual tumour-associated mutations, Precede Bio’s liquid biopsy approach can measure epigenetic changes in cancer cells using just 1mL of plasma, providing insight into tumour transcription networks, according to Carl Barrett, chief scientific officer at Precede Bio, in an interview with Medical Device Network. 

The minimally invasive assay could be used to guide treatment options for patients with HER2 and oestrogen receptor (ER) positive cancers. HER2 and ER are proteins that can promote cell growth in certain types of cancer. HER2 is involved in cell growth and replication, whereas ER is involved in responding to the hormone oestrogen.  

A reliable assessment of HER2 expression across solid tumours is needed for emerging therapeutic treatments such as antibody-drug conjugates (ADCs), cell therapies and radio conjugates. AstraZeneca’s ADC Enhertu (trastuzumab deruxtecan) recently received US Food and Drug Administration (FDA) accelerated approval for any HER2-positive solid tumours. According to Precede Bio, a standardised approach across all solid tumours will enable harmonised patient selection for Enhertu. 

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The Dana-Farber Cancer Institute spinout launched in October 2023 with $57m in seed funding, backed by pharma giant Bristol Myers Squibb (BMS). Precede Bio plans to bring the assay to the market soon. Beyond that, the assay could have applications outside of oncology. 

“The really exciting thing is that this assay can pick up changes in non-oncology indications, from particular autoimmune diseases such as multiple sclerosis, rheumatoid arthritis, and lupus. This opens new opportunities for precision medicine outside of oncology, which I think will be really important,” said Barrett.