Truseltiq is a new option for FGFR2 fusion-positive, locally advanced, or metastatic cholangiocarcinoma patients who have received prior treatment.
The Hopkins team expects to spinout a company soon in order to commercialize the technology in the next two to three years.
The study found more than 10,000 viruses and hundreds of bacteria not present in any reference database, along with other novel genomic features.
The researchers have used the platform, which enables screening of autoantibodies against extracellular proteins, to study diseases like lupus and COVID-19.
Epigenetic signatures of Ewing sarcoma affect cell-free DNA fragmentation patterns and can be used to detect cancer.
The approval makes Lumakras the first inhibitor of KRAS, once considered "undruggable," to reach the market for KRAS-mutated NSCLC.
Novacyt has launched VersaLab Portable, an eight-piece portable molecular testing lab in a lightweight carrying case for rapid-turnaround and on-site PCR testing, initially COVID-19 testing. The system includes Novacyt's PROmate rapid direct-to-PCR COVID-19 assay running on the Genesig q16 PCR instrument, which can provide results in under 80 minutes with just a single pipetting step. The portable lab also provides a Bluetooth barcode scanner, adjustable pipette, vortex mixer, sample tube rack, magazine rack, pipette tips, and 8-GB memory stick, according to the company's website. Novacyt said that VersaLab Portable includes all equipment required to provide near-patient PCR testing using the PROmate workflow in non-clinical settings such as offices and workplaces.
MicroGen Diagnostics (MicroGenDx) has released the OrthoKey and OrthoKey Surgery workflows for diagnosing orthopedic infections.
OrthoKey integrates synovial fluid analyses for biomarkers and white blood cell count with other parameters needed to diagnose periprosthetic joint infections based on International Consensus Meeting diagnostic criteria. This evidence-based, algorithmic approach provides clinicians with the likelihood of infection with additional guidance on antimicrobial treatment through the analysis of 17 antimicrobial resistance genes, the company said. OrthoKey offers comprehensive, actionable diagnostic information in one to two days, followed by NGS identification of causative bacteria and fungi in three to five days, the company said.
OrthoKey surgery comprises the same workflow but includes the CaptiGen flat swab for absorption of microbial DNA, biofilm retrieval, and nucleic acid extraction.
The aim within the initiative is to generate and assess real-world evidence, and use the data to support reimbursement for precision oncology therapies.
The Q20+ chemistry, heading soon to early-access users, is one of several recent updates to the Oxford Nanopore sequencing platform.
Guardant has asked the court to recover damages and to prevent Natera from further disseminating "deceptive" advertising regarding their competing assays.
The proposed change would delete payable cancer codes if they contain the word "unspecified" even if the word is included in a code that doesn't impact coverage.
Oxford Nanopore Technologies has released the new Ultra-Long DNA Sequencing Kit, for use in combination with Circulomics' Nanobind Kits.
The transposase-based kit maximizes the quantity of ultra-long reads and enables continuous sequencing of single DNA fragments up to 4.2 Mb. Users can get more than 100 reads over 1 Mb per PromethIon flow cell.
Lucira Health announced that Kevin Collins has joined the company as its chief revenue officer with global revenue responsibility. He most recently served at dialysis technology firm Outset Medical as VP of international commercial operations. He previously worked at medical robotics company Intuitive Surgical, where he served as VP of global distribution markets. He began his career at Lumenis where he was a regional sales manager for lasers.
The Boston-based company said it will use the funds to ramp up manufacturing of its FDA-cleared Binx io molecular point-of-care instrument, among other things.
Australian molecular diagnostics firm AusDiagnostics has appointed Marco Calzavara as its business director for the UK and Europe. He is the founder and former president of biotech firm Bioline, now part of Meridian Bioscience. The company also said that its former COO for AusDiagnostics UK, Richard Hale, will transition to a scientific consultant position for AusDiagnostics.
The San Diego-based sequencing technology firm added nearly 2 million shares on the eve of its IPO, and its shares rose 17 percent on the first day of trading.
The analysis drew upon data from the Million Veteran Program and other large-scale efforts and underscores the genetic complexity of depression.