NEW YORK – Thermo Fisher Scientific said this week that the US Federal Bureau of Investigation has approved its Applied Biosystems RapidHit ID System for use by accredited forensic DNA laboratories to process DNA reference samples and search resulting profiles against the US National DNA Index System (NDIS) CODIS database without manual interpretation and review.
The automated genetic analyzer can process a DNA reference sample in as little as 90 minutes. It consists of the Applied Biosystems RapidHit ID instrument, GlobalFiler Express typing kit, RapidHit ID ACE GlobalFiler Express sample cartridge, RapidHit ID Systems Software version 1.3, and RapidHit ID Expert System software version 1.0. A multi-site study of more than 1,100 buccal samples involving agencies in Louisiana, Arizona, California, and Florida showed that the system's performance is suitable for single-source reference samples and comparable to traditional lab results. The approval means the system can now be used in booking stations for fast DNA processing and for automated review of the vast majority of profiles.
Thermo Fisher Scientific said during its virtual analyst meeting this week that it now expects third quarter organic revenues to grow 24 percent, up from a previous estimate of 15 percent in July. For the fourth quarter, the company expects organic revenues to grow 13 percent to 27 percent, and for full year 2020, it expects revenue growth of 13 percent to 16 percent.
Fulgent Genetics announced this week a partnership with Florida’s Miami-Dade County to provide RT-PCR-based COVID-19 tests as well as the firm’s Community Testing Platform for managing drive-through testing sites.
Personal Genome Diagnostics announced this week that its PGDx Elio Tissue Complete assay is now covered under a previous local coverage decision from the Center for Medicare and Medicaid Services’ MolDx program. The genomic profiling kit, which is cleared by the US Food and Drug Administration, identifies alterations in tumors and can help inform treatment decisions for patients with advanced solid tumors.
Under the LCD, next-generation sequencing tests for solid tumors are covered when the patient has either recurrent, relapsed, refractory, metastatic, or advanced cancer; is seeking further treatment; and hasn’t been previously tested by the same test for the same genetic content. The test must also have completed a technical assessment for its stated indications and include "at least the minimum genes and genomic positions required for the identification of clinically relevant FDA-approved therapies with a companion diagnostic biomarker as well as other biomarkers known to be necessary for clinical decision making for its intended use that can be reasonably detected by the test," according to CMS.
Qiagen said this week that it plans to launch a rapid portable test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes. The firm said it will be able to process on average around 30 swab samples per hour using a small digital detection system. The Access Anti-SARS-CoV-2 Antigen Test, which is expected to be available in the fourth quarter of 2020, is the result of Qiagen’s alliance with Australian digital diagnostics firm Ellume. Qiagen said the news test will be the second COVID-19 test to make use of Ellume’s digital eHub and eStick system, following the launch of the Access Anti-SARS-CoV-2 Antibody Test that uses the same devices.
Qiagen said that feasibility tests have shown that the Access Antigen Test has a sensitivity of at least 90 percent and a specificity of 100 percent.
Qiagen said it will apply for Emergency Use Authorization from the US Food and Drug Administration and seek a CE-IVD Mark for the test. In addition, it noted that a CLIA waiver in the US would allow the point-of-care version to be used in settings like airports or stadiums.
ACT Genomics said this week that it has completed the first closing of a round of equity financing of undisclosed size from a group of strategic investors that include Aflac Ventures and Kyoto University Innovation Capital.
Proceeds from the round will allow the firm to further expand its technology, product portfolio, and global presence. The company also plans to partner with its new strategic shareholders to become a global player in cancer genome diagnostics.
ACT Genomics, founded in 2014, currently has sequencing labs in Taiwan, Hong Kong, and Japan, and other operations throughout Asia. Four years ago, the firm raised $12.5 million in a Series B financing round.
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.