Illumina received an emergency authorization from the FDA for its COVID-19 test designed to sequence the full genome of the novel coronavirus.
Using the company’s high-throughput NovaSeq 6000 hardware, the diagnostic COVIDSeq Test is capable of processing over 3,000 samples at once, taken from nasopharyngeal and oropharyngeal swabs. Results are provided within 24 hours.
“COVIDSeq leverages the performance of [next-generation sequencing] to help address the global need for diagnostic testing to fight the COVID-19 pandemic,” Illumina CEO Francis deSouza said in a statement.
“Beyond diagnostic testing, Illumina and a number of our customers are exploring NGS-based workflows to enable high-volume screening to support a return to work and school,” deSouza said.
The test targets and amplifies 98 different segments of the SARS-CoV-2 genome, which Illumina says gives the kit high accuracy and sensitivity. COVIDSeq will first be available to a limited number of sites before expanding over the summer, the company said.
In mid-March, Illumina partnered up with metagenomics company IDbyDNA to offer new workflows focused on the coronavirus and other infectious diseases—including a co-marketing agreement for the latter’s Explify platform, which runs on the sequencing giant’s hardware.
That includes a DNA-based diagnostic that can identify over 50,000 microorganisms and 3,000 pathogens in the clinic as well as potential resistance profiles to antimicrobial drugs.
By: Conor Hale
Source: Fierce Biotech
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion for the company’s Sogroya therapy. The once-weekly treatment – also known as somapacitan – is for the replacement of endogenous growth hormone (GH) in aged children three years and older.
Medtronic is set to acquire EOFlow, the South Korea-based maker of an insulin patch pump. In its announcement of the deal Thursday, Medtronic suggested that integrating the tubeless device with its own continuous glucose monitors and meal-detection algorithm could create a new closed-loop system for largely hands-off diabetes management.
Apnimed started the year by bagging nearly $80 million in extended series C funds and the momentum has kept up, with the sleep-apnea-focused biotech nailing its goals in a phase 2 study. “For those who cannot tolerate current treatments, AD109 has the potential to be a convenient, oral pill that could improve people’s quality of life both at night and during the day.”