With rates of preeclampsia skyrocketing, the U.S. FDA’s510(k) clearance of Roche Holding AG’s Elecsys test for preeclampsia offers some hope of reducing the number of women and infants who die or experience life-long consequences from the development of dangerously high blood pressure during late pregnancy and in the days immediately following delivery.
Taipei, Taiwan- and Watertown, Mass.-based Syncell recently raised $15 million in series A financing to advance its subcellular protein purification and spatial proteomics analysis product called Microscoop Mint, based on its Microscoop platform technology.
The recent agreement between Devyser Diagnostics AB and Thermo Fisher Scientific Inc. to collaborate to obtain U.S. FDA approval for a next-generation sequencing (NGS) test for kidney transplant monitoring allows the test to be democratized, Fredrik Alpsten, CEO of Devyser to BioWorld.
Abionic SA received U.S. FDA 510(k) clearance for its in vitro diagnostic Capsule pancreatic stone protein (PSP) sepsis test. Produced by the pancreas and immune cells, PSP provides an early biomarker for sepsis that could push back detection of deadly condition by 24 to 48 hours.
Angle plc’s Parsortix system, which captures and harvest circulating tumor cells (CTCs) for liquid biopsy analysis, has been used in breakthrough work by researchers at the University of New Mexico looking into the role of CTC gene expression in the progression of melanoma brain metastasis. The researchers used the Parsortix system to harvest CTCs for analysis and concluded that “… gene expression in CTCs could be pivotal to prescribing more targeted treatment based on the needs of the patient.”
Olink Holding AB likely has some euphoric investors following Thermo Fisher Scientific Inc.’s announcement of an agreement to acquire the proteomics company for $26 per share in cash. The price represents a premium of nearly 75% on its recent trading average and brings the deal’s value to a stunning $3.1 billion, with net cash of $143 million.
China’s recovery from its zero-COVID policy has failed to gain the momentum expected, with many experts predicting a slow or even negative growth rate. A slower economy, combined with a push toward self-reliance, bodes poorly for diagnostics manufacturers in the U.S. who may find themselves not just shut out of the huge market but facing stiffer competition around the globe. Further, policies designed to build a domestic next-generation sequencing industry have created headwinds for San Diego-based Illumina Inc. and others, noted Kyle Mikson and Alex Vukasin of Canaccord Genuity in an in-depth report.
The U.S. FDA granted clearance to two tests developed by Thermo Fisher Scientific Inc. to predict preeclampsia, Brahms PIGF plus Kryptor and Brahms sFlt-1 Kryptor. Both had previously received breakthrough designation. Preeclampsia, a hypertensive disorder, is the leading cause of maternal and fetal mortality and morbidity across the globe.
Some patent litigation cases don’t require a deep effort to interpret claims, but the litigation between Agilent Technologies Inc., and Dionex Softron GmbH, forced the Court of Appeals for the Federal Circuit to determine whether a written description adequately captures the use of a piston in a liquid chromatograph to avoid nullification of the claim.
