PERTH, Australia – Australia’s budget theme for the 2021 to 2022 fiscal year is rebuilding the economy following COVID-19, and med-tech and biotech leaders were praising some of the new measures.
The discovery of synthetic lethality between BRCA mutations and PARP inhibitors ranks has led to major advances in the treatment of BRCA-mutated cancers. Mutations in BRCA1 and BRCA2 can leave cells with a deficiency in homologous repair (HR). And that deficiency can make them vulnerable to PARP inhibitors, which block alternate DNA repair pathways, as well as platinum-based treatment, which induces DNA mutations that BRCA-deficient cells are unable to cope with.
PERTH, Australia – The FDA granted Oncores Medical Pty. Ltd. breakthrough device designation for its quantitative micro-elastography (QME) imaging system. The hand-held imaging tool helps surgeons differentiate between cancerous and healthy tissue in real time at the point of surgery, and it could substantially improve outcomes in breast-conserving surgery (BCS) and reduce repeat operations for women with breast cancer.
The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.
LONDON – Neogenomics Inc. reported it plans to acquire Inivata Ltd., taking up a $390 million fixed price option to purchase the liquid biopsy specialist eight months early. The option was agreed to in May 2020, when Neogenomics made a $25 million minority equity investment in Inivata and was granted the right to acquire the rest of the company by the end of 2021.
My01 Inc. has received FDA clearance for its My01 Continuous Compartmental Pressure Monitor with full Bluetooth capabilities. The device is intended to help doctors diagnose and avert the risks of developing compartment syndrome, a potentially devastating complication of certain fractures and trauma injuries.
PERTH, Australia – Imagion Biosystems Ltd. has entered a collaborative research program with therapeutic antibody development company Patrys Ltd. to combine their technologies to target brain tumor imaging and diagnosis.
Soulbrain Holdings Co. Ltd. ramped up its unusual diversification program with the acquisition of Pixcell Medical Technologies Ltd. as part of the semiconductor company's shift into health care and in vitro diagnostics. The acquisition of Pixcell follows Soulbrain’s acquisition of Ark Diagnostics Inc. in 2018 as the company looks to the bio-health care industry as its "engine for new growth."
Laboratory Corporation of America Holdings (Labcorp) further consolidated its position as a leading provider of rheumatoid arthritis testing with a definitive agreement to acquire the Vectra assay from Myriad Genetics Inc. along with other assets of the Salt Lake City-based company’s autoimmune business unit in a deal valued at $150 million in cash. The transaction is expected to close by the end of the third quarter of 2021.
Molli Surgical Inc. has won the FDA’s nod for its wire-free localization technology for breast cancer surgery. The company said the Molli system helps radiologists tag cancerous lesions quickly and precisely, facilitating surgical excision and eliminating a source of anxiety associated with breast tumor removal.
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