PARIS – Ziwig SAS has developed the Endotest saliva test, for quickly detecting endometriosis. François Golfier, head of the gynecology-obstetrics department at Angers University Hospital and chairman of the endometriosis committee for the National College of French Gynecologists and Obstetricians, claims this new generation of in vitro diagnostic medical devices is going to be a game-changer “as it finally allows this chronic debilitating disease to be detected sooner and within the space of just a few days.”
Visby Medical Inc. reeled in more than $100 million in a series E round led by Ping An Voyager Partners. The funds will be used to scale production capacity of Visby’s instrument-free, single-use real-time polymerase chain reaction (RT-PCR) platform from tens to hundreds of thousands of tests per month.
Chinese company Seekin Inc. is preparing to launch its cancer detection technology in Europe after securing CE marking for the Seekincare pan-cancer test. The artificial intelligence, blood-based platform uses insights from public and private data to identify cancer DNA and protein signals in the blood. The test has been available in Chinese labs since 2018.
Selux Diagnostics Inc. raised $50 million in a series C financing to support the commercial launch of its next-generation phenotyping (NGP) rapid antimicrobial susceptibility testing platform. RA Capital Management LLC led the round with participation from Sands Capital, Schooner Capital and Northpond Ventures, all returning investors.
The U.S. is making strides in addressing the drug and device supply chain vulnerabilities revealed by the COVID-19 pandemic, but there’s still a lot of work to do to reduce dependance on sole source suppliers and foreign manufacturing, according to a new Health and Human Services (HHS) report.
Oxford Biodynamics plc is launching its clinical assay Episwitch CIRT in the U.S. following clinical validation that demonstrated the 3D genomic eight biomarker panel can predict a cancer patient’s response to immune checkpoint inhibitor (ICI) therapy at up to 93% sensitivity, 82% specificity and 85% accuracy. ICIs are currently used against more than 15 types of cancer but less than one in three patients show any benefit from the treatment.
The European Union’s (EU) Medical Device Coordination Group (MDCG) posted a guidance addressing verification of manufactured, high-risk in vitro diagnostics (IVDs), which indicates that manufacturers should submit samples to a reference lab for batch testing. However, the requirement for batch testing may not apply if no European reference lab has been designated for a test type, suggesting that some high-risk tests may go to market without adequate testing.
PARIS – Siemens Healthineers AG has unveiled its growth plans for 2025 at its annual general meeting. The Erlangen, Germany-based medical technology giant, valued at nearly $67 billion on the Frankfurt stock exchange, is ramping growth. “We are setting ourselves the objective of annual growth of up to 8% on a like-for-like basis up to 2025, compared with a previous objective of 5%,” said Ralf Thomas, supervisory board chairman, Siemens Healthineers AG. Adjusted earnings per share should, accordingly, rise by 15% a year over that period as part of this strategic plan, compared with a target of at least 10% previously.
It’s no mystery why Scipher Medicine Corp. successfully raised $110 million in a series D financing round to further develop the company’s precision medicine platform. The company aims to address one of most modern medicine’s most challenging enigmas: how to eliminate the cost and adverse effects associated with the prescription of expensive medications that provide life-changing outcomes for some and no benefit for others. The new funds boost Scipher’s total funding to $227 million, of which $192 million has come into the Waltham, Mass.-based company’s coffers in the last 12 months.
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