NEW YORK – Roche Diagnostics announced this week that it has received an EU Quality Management System Certificate (IVDR) for more than 700 of the company’s catalogue numbers. The certification is for products in the serum work area and lab coagulation portfolio and was awarded by TÜV SÜD Product Service, one of the notified bodies under the EU's new In Vitro Diagnostics Medical Devices Regulation (IVDR). The certificate is required for products to be CE-marked under the new regulation, which is replacing the current In Vitro Diagnostic Medical Devices Directive. Roche said it is the first manufacturer to receive the certification.
Subsequent to the Roche announcement, standards group BSI said that it certified its first group of IVDR products through its Netherlands Notified Body. The certificate covers two Class C Generic device groups for Monoclonal Antibodies/Flow Cytometry, and the first certificate was granted to Becton Dickinson.
Charitable organization Stand Up To Cancer received a $10 million grant from molecular diagnostics firm Exact Sciences, which it will put toward funding new colorectal cancer screening research and a campaign to raise awareness of the importance of screening and early detection in underserved communities. A "dream team" of researchers will receive funding in early 2021 to provide free testing within underserved communities; study-collected samples using colonoscopy, CT colonography, flexible sigmoidoscopy, and at-home fecal DNA or blood tests; and advance better approaches to identifying those with colorectal cancer. The grant will also support early-career fellows who want to study health disparities in colorectal cancer.
Fulgent Genetics will collaborate with PRA Health Sciences and PWNHealth to expand existing COVID-19 clinical monitoring, symptom reporting, and management services on a patient-facing mobile app. The collaboration allows patients to order an at-home testing kit from Picture by Fulgent Genetics directly through PRA's Health Harmony app, if recommended by a clinician. Under the agreement, Fulgent will supply the Emergency Use Authorized at-home COVID-19 diagnostic test kits, process the samples, and return the results to patients within 24 to 48 hours of sample receipt.
Veracyte said this week that it has expanded its collaboration with the Lung Cancer Initiative at Johnson & Johnson, which has focused on developing the firm's lung cancer tests. The partnership will now additionally focus on the NOBLE Trial, a 9,000-patient prospective, multi-center clinical study that will distinguish genomic and other differences in lung cancer development and progression among patients with lung nodules detected by CT imaging.
Oxford Immunotec announced this week the formation of the Global T cell Expert Consortium (GTEC), which consists of experts in T-cell research, epidemiology, vaccine research, and global public health. GTEC is an independent forum, supported by Oxford Immunotec, with an agenda, research, and associated education driven by the consortium experts. Its objective is to advance the frontiers of T-cell research and education and raise the profile of T cells to the level of antibodies in the minds of doctors, governments, and the public, Oxford Immunotec said.
QuantuMDx Group said this week that is investing more than £11 million to scale up production to mass manufacture its flagship diagnostic device, Q-POC and disposable test cassette. The Newcastle Upon Tyne, UK-based firm said that its first commercial assay for the portable, PCR-based system will detect SARS-CoV-2 and Flu A & B. QuantuMDx said it expects to achieve CE-IVD marking for its Q-POC system in early 2021, following a release for research use only.
Yourgene this week reported additional financial results for the first half of its fiscal year 2020. The company had already reported a 5 percent increase in H1 revenues in October.
For the half-year period ended Sept. 30, Yourgene reported a net loss of £2.5 million ($3.4 million), or .4p per share, compared to a loss of £1.4 million, or .2p per share, during the same period last year.
The company had £192,000 in R&D expenses, down 50 percent from £382,000 a year ago. General administrative expenses increased 21 percent to £5.2 million from £4.3 million last year, related to the firm's Iona Nx transition program, manufacturing scale-up and testing laboratory provisioning, and incremental acquired overheads.
The firm revised its cash and cash equivalents as of Sept. 30 to £12.2 million from a previously reported £11.9 million.
During the second half of its fiscal year so far, Yourgene was awarded a renewed three-year contract with St. George's University Hospitals NHS Foundation Trust for its new Iona Nx NIPT workflow and signed partnerships in Japan for its bioinformatics platform and in Taiwan for nasopharyngeal cancer research.
Qlucore said this week it has received a grant from the Swedish Governmental Agency for Innovation Systems, Vinnova, to expand Qlucore Diagnostics, a new diagnostic software product to improve clinical cancer diagnostics with a focus on RNA profiling of glioma and acute leukemia. Carl-Johan Ivarsson, president of Qlucore, said in a statement that the grant, the amount of which was not disclosed, will help the Swedish company rapidly develop a clinical-grade diagnostic software tool for use by individual clinical labs. The firm is building the software on a flexible, generic platform based on standardized NGS workflows "with a focus on superfast visualization and capabilities to handle integrative models with data from different sources," Qlucore said.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.