Thermo Fisher Scientific said today that it plans to redeem two classes of senior notes later this month, with a total aggregate principal amount of $1.1 billion.
The service uses Hc1's machine learning technology to collect and analyze lab data, allowing systems to identify areas where usage is inappropriate or inefficient.
The firm said the clearance authorizes use of its smartphone-based albumin-to-creatinine ratio test by healthcare professionals at the point of care.
The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.
The Royal Oak, Michigan-based startup will use the funding to support development and commercialization of its pan-disease diagnostic testing platform.
About $770 million in net proceeds will go toward the repayment of outstanding debt under its senior unsecured revolving credit facility.
The firm said that the funding may be used to support further development of its portfolio of diagnostics for sepsis-causing pathogens and antibiotic-resistance genes.
Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies — IgG and IgM — to the hepatitis A virus.
Pathologie-DNA will implement the anatomic and clinical pathology online support system, which is used to decide which ancillary tests to run on patients.
The company will work with the Genome Institute of Singapore to create a test for breast cancer recurrence prediction using its circulating tumor cell platform.
The study said that Cologuard was an "inefficient screening option" for colorectal cancer given its cost as compared to other CRC screening methods.
The funding is being provided by the Flemish government's Agency for Innovation and Entrepreneurship to support the three-year development project.
The firms plan to use Thermo Fisher's Oncomine Dx Target test to identify cancer patients with RET alterations who might benefit from Lilly's LOXO-292.
The partners will use Biolidics' circulating tumor cell retrieval system to evaluate the cells' utility as biomarkers of patient response to cancer treatment.
The revised document addresses a number of issues related to submission of HUD designation requests, which is the first step in seeking marketing approval of such a device.
The company said it will use the funds to repay the $75 million outstanding under its 2018 Note Purchase Agreement, to expand internationally, and on general operations.
The in vitro diagnostic company said it would use the financing to commercialize its antibiotic susceptibility platform called Reveal.
The test is the first near-patient assay for M. genitalium, and can also guide treatment by detecting antibacterial resistance markers.
The company plans to use the proceeds to fund the redemption of its outstanding 5.00 percent senior notes due 2020.
The agency said its guidance provides transparency about a Humanitarian Device Exemption pathway associated with rare diseases affecting up to 8,000 people.
The firm said that its rapid point-of-care test enables immediate drug adjustments by measuring levels of clozapine, an antipsychotic drug, in a finger prick of blood.
The French metagenomic sequencing firm received funding from both historical and new investors, including debt financing from Norgine Ventures.
OncoCyte believes Razor's CLIA-validated lung cancer prognostic test will complement its in-development DetermaVu lung cancer detection assay.
The Belgian oncology molecular diagnostics firm reported a 17 percent increase in product sales but said that sales of cartridges in the US were lower than expected.