LONDON – The genomes of 38 different tumor types and the 47 million mutations that fostered their growth are revealed in unprecedented detail in 23 studies published in Nature and other journals on Feb. 6, 2020.
Houston-based Nanospectra Biosciences Inc. has kicked off a pivotal U.S. study of its Aurolase therapy in the targeted destruction of prostate tumors using nanomedicine technology. The IDE study, with an estimated completion date of December 2022, will support a de novo 510(k) submission to the U.S. FDA. The first two patients were treated at the University of Michigan, which also participated in the first-in-human pilot study of Aurolase.
PARIS – The European mammography division of GE Healthcare Inc., based in Buc, France, has just performed the first breast biopsy guided by angiomammography, using the Pristina Serena biopsy robot on a patient at the Gustave Roussy Institute in Villejuif, France.
HONG KONG – South Korea’s Genomictree Co. Ltd. has said its U.S. branch, Promis Diagnostics Inc., based in Pasadena, Calif., gained $30.8 million in funds this month. The Daejeon-based company has secured $40.8 million for its U.S. subsidiary since founding it in August 2019.
The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.
Tempe, Ariz.-based Gt Medical Technologies Inc. has won the U.S. FDA’s nod for an expanded indication for Gammatile therapy. With this decision, patients with newly diagnosed malignant brain tumors now are eligible to receive the FDA-cleared surgically targeted radiation therapy. Gammatile therapy offers an option vs. waiting several weeks for surgical wound healing before beginning treatment. Previously, the therapy was available for individuals with recurrent brain tumors.
Liquid biopsy startup Elypta AB has raised €6.1 million (US$6.72 million) in a late seed financing led by Industrifonden and Sciety. Norrsken Foundation’s newly launched €100 million “impact-first” fund also contributed to the round. The Stockholm-based company plans to use the money to complete development of laboratory kits and software for measurement and analysis of a panel of metabolites it has identified.
SANTA CLARA, Calif. – Just as it does with treatments, the National Comprehensive Cancer Network (NCCN) offers detailed guidelines on genomic testing by cancer type. These are key in determining what physicians can prescribe routinely and what insurers will cover. But those guidelines aren’t followed regularly outside a major research hospital setting, thereby obviating access to tumor genetic information that could help to better guide treatment. Even if current guidelines are followed, physicians and patients can get information back from the tests that neither party is prepared to process.
Nearly 70% of men with locally recurrent prostate cancer who received radiation therapy initially could delay androgen deprivation therapy (ADT) for at least five years following stereotactic body radiation therapy (SBRT) with Accuray Inc.’s Cyberknife system, according to a study published in the International Journal of Radiation Oncology • Biology • Physics.
Unlike with other kinds of cancer, there’s no opportunity for a biopsy ahead of surgery for a suspected brain tumor. To help matters, researchers have developed a novel approach that combines a new, commercially available imaging technology – stimulated Raman histology (SRH) – with an artificial intelligence (AI) algorithm to offer a diagnosis of brain tumors in just a couple of minutes. They published the results of a study in the Jan. 6, 2020, issue of Nature Medicine that determined their approach was noninferior to standard pathologist interpretation of histologic images.
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