LONDON – Biofidelity Ltd. has raised US$12 million in a series A, enabling it to start commercialization of a novel, low-cost, chemistry-based diagnostic for detecting all actionable lung cancer mutations. The Cambridge, U.K.-based company claims the test can detect a single molecule of mutated DNA against the background of billions of healthy molecules in a patient sample, without the need for DNA sequencing.

Deep Lens Inc.’s artificial intelligence trial screening and enrollment platform, Viper, will be integrated with Franciscan Health Cancer Center's electronic health record to enable matching of cancer patients with suitable clinical trials starting at diagnosis over the next month. By working together, the two Midwest-based organizations hope to increase the number of patients benefiting from clinical trials and overcome some of the challenges to participation posed by the pandemic.

The U.S. FDA has greenlighted two new modules for Siemens Healthineers’ AI-Rad Companion platform, giving radiologists new artificial intelligence (AI) tools to assist in interpreting magnetic resonance imaging (MRI) studies of the brain and prostate. The AI-Rad Companion Brain MR for Morphometry Analysis and AI-Rad Companion Prostate MR for Biopsy Support join earlier intelligent software modules for Chest CT.

Thermo Fisher Scientific Inc. released updated software and new instructions for its Taqpath COVID-19 Combo Kit, a widely used COVID-19 test kit that is also the basis for several other coronavirus diagnostics, following issuance of a letter to clinical laboratory staff and health care providers by the U.S. FDA about the risk of false results with the test. Separately, the Waltham, Mass.-based company has released the first in a series of hematology-oncology assays designed to run on its Ion Torrent Genexus system.

PARIS – Integragen SA and OncoDNA SA have signed a tender offer agreement anticipating a takeover bid. Gosselies, Belgium-based OncoDNA will purchase 100% of the shares of Integragen, floated on the Euronext Paris Euronext Growth Markets, at a unit price of $2.60, valuing the latter’s share capital at $17.2 million.

Cryoablation technology firm Icecure Medical Ltd. raised $6 million (₪20.7 million) in an oversubscribed equity offering. The Caesarea, Israel-based company (TASE:ICCM) plans to use the funds for continued expansion of operations in the U.S., Europe and Asia.

The U.S. FDA revealed good news for Guardant Health Inc. Specifically, the agency has given a thumbs up for Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm. The Redwood City, Calif.-based company noted that this marked the first approval to combine next-generation sequencing (NGS) and liquid biopsy in one diagnostic test to guide treatment decisions. The assay previously was granted a breakthrough device designation.

Investigators at Weill Cornell Medical College have demonstrated that mitochondrial DNA drives the abscopal antitumor response to radiation, which can be boosted by autophagy inhibition.

In what one analyst labeled as a “summer surprise,” Varian Medical Systems Inc. and Siemens Healthineers AG said they plan to combine in an all-cash transaction valued at $16.4 billion. Varian’s board has backed the agreement, which will see Siemens Healthineers pick up all outstanding shares for $177.50 per share in cash, representing a premium of about 42% to the 30-day volume weighted average closing price of Varian's common stock as of July 31. The transaction is expected to close in the first half of calendar year 2021.