NEW YORK (360Dx) – Illumina said this week that the US Food and Drug Administration has granted breakthrough device designation for its pan-cancer assay, which is currently in development. Illumina plans to market the assay as TruSight Oncology Comprehensive. It will be based on the content of the firm's TruSight Oncology 500 (TSO 500) assay, which is designed to detect known and emerging biomarkers for solid tumors.
Illumina is seeking FDA approval for the assay as a companion diagnostic. The assay uses both tumor DNA and RNA to identify variants, including small DNA variants, fusions, and splice variants, as well as immunotherapy-associated biomarkers, such as tumor mutational burden and microsatellite instability.
Novacyt this week reported that unaudited revenues from continuing operations for full-year 2018 are expected to grow 9 percent on a constant exchange rate and on a consolidated basis to €13.7 million ($15.6 million). Earlier this month, the firm projected revenues in the range of €13.7 million to €14.4 million. Continuing operations include the Primerdesign and Lab21 business units and €1 million of Omega Infectious Disease product sales. Excluding the Omega ID business, core business growth was up 1 percent. The company had €1.1 million in cash at the end of 2018.
Novacyt said in December that it would divest its Novaprep cytology business and clinical laboratory operations in order to focus on in vitro diagnostic product development and its profitable Lab21 and Primerdesign diagnostic reagent units. It said this week that progress is being made on the sale of both the Novaprep and clinical lab businesses.
The Lustgarten Foundation announced this week that it has opened its fourth dedicated pancreatic cancer research laboratory at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. The lab will be led by Bert Vogelstein. Research will focus on early detection to intercept pancreatic cancer at an earlier stage when patients may be surgical candidates, and on the development of novel therapeutic approaches to treat pancreatic cancer based on genetic alterations.
Singapore molecular diagnostics firm iGene Laboratory said this week that it received accreditation for its noninvasive prenatal test from the College of American Pathologists. The company, a wholly owned subsidiary of Inex Innovations Exchange, was previously certified by the Singapore Ministry of Health.
It set up a next-generation sequencing-based lab in the country in 2015 and provides testing services to clinics and hospitals in Singapore and other countries in the region, including Malaysia, Indonesia, Cambodia, and Myanmar.
Indian clinical laboratory Core Diagnostics this week announced it has launched a new division called NephroCore to provide advanced diagnostic services. Its focus will be on improving outcomes in chronic and severe kidney diseases. New nephrology-related diagnostic tests being offered include advanced nephro-pathology services, molecular testing for rare and inherited kidney diseases, screening for pre- and post-transplant infectious diseases, drug level monitoring, and transplant immunology.
Becton Dickinson's board this week declared a quarterly dividend of $.77 per common share, payable on March 29 to shareholders of record on March 8. The indicated annual dividend rate is $3.08 per share. The board also declared a quarterly dividend of $15.31 per share on 6.125 percent mandatory convertible preferred stock, Series A, payable on May 1 to shareholders of record on April 15.
PerkinElmer's board this week declared a regular quarterly dividend of $.07 per share of common stock, payable on May 10 to shareholders of record at the close of business on April 19.
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.