Day Zero Diagnostics — which seeks to harness whole-genome sequencing and AI in the fight against antibiotic-resistant infections — announced today that it has successfully wrapped up a $16M financing round. The latest round raises the Boston-based company’s venture capital funding total to $49M, coupled with over $18M in non-dilutive funding. “This funding is a […]
Genomics/Molecular Diagnostics
Illumina picks a new CEO amid SEC investigation
Illumina (Nasdaq: ILMN) — the DNA sequencing and array-based tech developer — has tapped an Agilent Technologies executive as its new CEO as it seeks to move beyond regulatory scrutiny of its acquisition of Grail. Jacob Thaysen, an Agilent Technologies SVP and president of its Life Sciences and Applied Markets Group, takes over Illumina’s corner […]
Illumina says SEC is investigating Grail acquisition
Add a U.S. Securities and Exchange Commission investigation to the list of problems that Illumina has faced since it acquired Grail for $8 billion in 2021. Illumina disclosed the investigation in its 10-Q filed with the SEC on Aug. 10: “In July 2023, we were informed that the staff of the SEC was conducting an […]
FDA clears Abbott Alinity h-series hematology system
Abbott announced today that the FDA cleared its advanced Alinity h-series hematology system. FDA clearance enables laboratories to run complete blood counts (CBCs) as part of Abbott’s Alinity family of diagnostic products. CBCs, among the most ordered tests in healthcare, help to screen for a variety of disorders. That includes infections, anemia, diseases of the […]
FDA clears BD combo test for COVID-19, flu, RSV
BD announced today that the FDA granted 510(k) clearance for its respiratory viral panel (RVP). Franklin Lakes, New Jersey-based BD designed the RVP for its BD Max system as a single molecular diagnostic that identifies a number of viruses. It distinguishes SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in approximately two hours. […]
Hologic stock dips on Q3 losses, questions over future margins
Hologic shares fell this morning despite third-quarter results that topped the consensus forecast. Shares of HOLX dipped 4% at $76.29 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.6%. The Marlborough, Massachusetts-based women’s health and diagnostics company posted losses of $40.5 […]
Bio-Rad announces $500M share repurchase program
Bio-Rad Laboratories announced that its board of directors approved a new share repurchase program. The program grants the company authority to repurchase up to $500 million in outstanding shares of its common stock. “The new share buyback authorization is consistent with our disciplined approach and demonstrates our continued commitment to using this tool as part […]
EU hits Illumina with $478M fine over Grail deal
The European Commission announced today that it issued significant fines to Illumina (Nasdaq:ILMN) and Grail as a result of their proposed merger. European authorities fined Illumina approximately $478.9 million (€432 million) and Grail $1,108 (€1,000). They claim the companies implemented their proposed merger before approval by the Commission. Such actions breach European Union merger control […]
The top IVD innovation news stories of 2023 — so far
This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space. According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using […]
BD wants to increase education on sexually transmitted infections
Earlier this year, BD shared results from a survey of more than 1,000 U.S. women found significant discrepancies in education around sexually transmitted infections (STIs). Of these women, over 18 years old, 77% identified as knowledgeable about vaginal infections, including yeast infections. However, only 60% said they felt knowledgeable about treatment options for these infections […]
Illumina’s CEO resigns, MacMillan expresses confidence
Illumina Inc. (NASDAQ: ILMN) announced that CEO Francis deSouza has resigned from the DNA sequencing and array-based tech developer. The news, announced yesterday, comes more than a week after Hologic CEO Stephen MacMillan became non-executive board chair. Edwards Lifesciences CFO Scott Ullem filled a second new seat, bringing the board seat total to 12. Illumina […]