Merit Medical Systems Inc. received FDA 510(k) clearance for the Scout Bx delivery system, which enables the placement during stereotactic and MRI-guided biopsy of a reflector to guide breast surgery. The delivery system works with the company’s Scout reflector, a wire-free radar localization device.
Myriad Genetics Inc. is launching a new suite of genetic tests designed for personalizing chemotherapy treatment. The Precise oncology offering includes Myriad’s precise tumor molecular profile test and two companion diagnostic tests, Mychoice CDx and Bracanalysis CDx. The company said the combination of germline, somatic and companion testing aims to maximize information for oncologists as they assign individual treatment plans. Results from each test are gathered as a single report accessed on an online portal.
Sanofi SA has suffered a setback in its bid to find a successor to Astrazeneca plc’s breast cancer drug Faslodex (fulvestrant) as amcenestrant failed to improve progression-free survival in advanced breast cancer in a mid-stage trial.
“In 2015, when I started in this field…. people considered breast cancer a cold tumor,” Marleen Kok told the audience at the European Society of Medical Oncology’s 2022 Targeted Anticancer Therapy meeting (ESMO TAT). But the sensitivity of breast cancer to immunotherapy, or lack thereof, is “not a black and white phenomenon.”
PARIS – Resilience SAS raised $46 million in a series A round to ramp up European distribution of its mobile application intended for remote monitoring of breast cancer patients, in partnership with the Gustave Roussy Center in Villejuif, France. This funding round was led by two Parisian venture capital funds specializing in digital health – Cathay Innovation SAS and Singular Capital Partners SAS – along with Dutch-based Exor Seeds NV, German-based Picus Capital GmbH and Seaya Capital Gestion, SGEIC, SA, from Spain.
South Africa’s Competition Commission sent a warning this week to the biopharma industry when it announced that it is prosecuting Roche Holding AG for what it called excessive pricing of the company’s breast cancer drug, Herceptin, which is also marketed as Herclon in South Africa.
PARIS – Healshape SAS is preparing a $6.8 million series A round to develop a 3D bioprinted breast implant obtained from the patients' own cells. Supported by Pulsalys SAS, Lyon Saint-Etienne’s technology transfer acceleration company, this startup from Villeurbanne, France, has already benefited from more than a million dollars of French public funding and subsidies.
Illumina Inc. and Agendia NV are joining forces for a multiyear partnership to develop diagnostic tests for breast cancer. The collaboration will unite lllumina’s Miseq Dx sequencing platform, with Agendia's flagship genomic test, Mammaprint, which identifies a patient’s breast cancer recurrence risk. Illumina has been steadily signing partnerships over the past few years and currently has more than 30 IVD partners and 40 sequencing-based solutions for cancer under development.
Legochem Biosciences Inc. has licensed out its antibody-drug conjugate (ADC) LCB-14 to Iksuda Therapeutics Ltd. in the duo’s latest deal that is worth $1 billion. Daejeon, South Korea-based Legochem will receive $50 million in an up-front payment and near-term milestones, and up to $950 million in developments, regulatory and commercial milestones.
Prelude Corp. (dba Preludedx) reported positive results from the SweDCIS randomized trial showing its DCISionrt test predicts radiation benefit for lowering 10-year local invasive breast cancer risk. The prognostic, artificial intelligence (AI)-based tool assesses and predicts the benefit of radiotherapy for women with ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS).