Rarecyte Inc., a Seattle-based company making products for tissue and cell analysis, reported picking up $22 million in a series F financing round led by Healthquest Capital.
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February. Until now, Australia did not have a framework for CDx.
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February.
Rarecyte Inc., a Seattle-based company making products for tissue and cell analysis, reported picking up $22 million in a series F financing round led by Healthquest Capital. Also participating in the round were existing investors 5AM Ventures and Ron Seubert, Rarecyte’s founder and chief technology officer. The company plans to use the funds to expand global sales of its instruments and consumables platform in research clinical markets.
Austin, Texas-based Asuragen Inc. is joining forces with Wave Life Sciences USA Inc., of Cambridge, Mass., to change the fatal trajectory of Huntington’s disease.
Huntington’s disease is a fatal hereditary disease that results in the progressive breakdown of nerve cells in the brain. It erodes a person’s physical and mental abilities, usually beginning in their 30s and 40s, and to date has no cure. Now Austin-based Asuragen Inc. is joining forces with Wave Life Sciences USA Inc., of Cambridge, Mass., to develop companion diagnostics (CDx) for Wave’s investigative allele-selective therapeutic programs targeting the genetic cause of the disease.
CEO Mark McKenna told BioWorld MedTech that San Diego-based Prometheus Biosciences Inc. has "cracked the code" in inflammatory bowel disease (IBD) – progress underscored by the firm's deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, which brings an undisclosed up-front payment and as much as $420 million more if development, regulatory and commercial milestones are reached in three programs.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.
Patent holders are wasting their resources when they ask the U.S. Court of Appeals for the Federal Circuit for an en banc rehearing on diagnostic claims that have been declared ineligible because they cite a law of nature.
