Dxcover Ltd. initiated three pivotal trials to measure the efficacy of its liquid biopsy platform for early detection of brain, colorectal and lung cancers. The company hopes the trials will provide the evidence needed to gain regulatory approval and begin commercial operations of its diagnostic technology in Europe and the U.S.
Dxcover Ltd. raised $9.25 million (£7.5 million) in a series A fundraising round and received a grant of $2.7 million (£2.2 million) from the European Innovation Council to support development of the company’s liquid biopsy platform for the detection of multiple early-stage cancers. Existing investors Eos Advisory LLP, Mercia Asset Management plc, Scottish Enterprise, University of Strathclyde, SIS Ventures and Norcliffe Capital led the round, which was also joined by Mark Banforth of Thairm Bio.
Burning Rock Biotech Ltd.’s share price flared up on Tuesday morning on news of U.S. FDA breakthrough device designation for its Overc multi-cancer detection blood test (MCDBT). The stock closed on Dec. 30, 2022, at $2.26 and rose sharply on the announcement to open at $2.89. By the end of the day, however, the stock had sunk to $2.15.
Thirteen months after Illumina Inc. and Grail Inc. merged, prior to regulatory approval, the deal has taken a turn for the worse. The prognosis looked better following an administrative law judge’s ruling Sept. 1 against the U.S. Federal Trade Commission’s lawsuit seeking to block the transaction, but the European Commission (EC) issued a decision Sept. 6 prohibiting the deal based on the likelihood that a merger would stifle innovation and limit choices in the early cancer detection liquid biopsy market.
Pillar Biosciences LLC hopes to build a stronger foundation for its multi-cancer in vitro diagnostic, Oncoreveal Dx. The company filed a supplemental application for U.S. FDA premarket approval of eight additional types of cancer, which the agency accepted for review. The assay received FDA premarket approval for use in non-small cell lung cancer (NSCLC) and colon cancer in August 2021.
A presentation at the American Society of Clinical Oncology (ASCO) 2022 annual conference demonstrated that the Dxcover Cancer Liquid Biopsy differentiated between patients with cancer and healthy controls and detected more than 90% of stage I malignancies across a broad range of cancers. Dxcover Ltd. provided more details on its new approach to the search for reliable, rapid screening for multiple malignancies at the 12th International Conference on Clinical Spectroscopy on June 21.