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In Brief This Week: AACC; Siemens Healthineers; Bio-Rad; T2 Biosystems; DermTech; More

NEW YORK –  The American Association for Clinical Chemistry announced this week that it will change its name to the Association for Diagnostics & Laboratory Medicine. The name change will be officially rolled out during the organization’s Annual Scientific Meeting and Clinical Lab Expo starting July 23. The name “more accurately reflects our diverse membership, which includes all professionals working within or adjacent to the clinical lab,” the organization said in a statement. 

Siemens Healthineers said this week that it received US Food and Drug Administration breakthrough device designation for the use of its Enhanced Liver Fibrosis Test to aid in the diagnosis of advanced fibrosis in patients with nonalcoholic fatty liver disease. That designation could hasten the path toward marketing authorization for earlier use of the test. The test measures the biomarkers hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase 1 and analyzes the results using a proprietary algorithm. The firm received FDA de novo marketing authorization in 2021 for prognostic use of the test to assess the likelihood that patients with nonalcoholic steatohepatitis will progress to cirrhosis and liver-related clinical events. 

Bio-Rad Laboratories announced this week that its board of directors has approved a new share repurchase program for up to $500 million of outstanding shares of its common stock. The company completed the repurchase of common stock authorized under the prior share repurchase program on June 5. The new program has no time limit and may be suspended or discontinued at any time. 

Gradientech this week received breakthrough device designation from the US Food and Drug Administration for its QuickMIC rapid antibiotic susceptibility test system. The QuickMIC system and a Gram-negative panel are CE-marked and commercially available in Europe but not yet available for sale in the US. 

T2 Biosystems reported this week that it has obtained breakthrough device designation from the US Food and Drug Administration for a direct-from-blood assay to detect Candida auris. The company previously received breakthrough designation for its T2 Resistance and T2 Lyme assays. 

DermTech said this week that it has received a favorable coverage policy for its molecular melanoma test from a Blues plan in Michigan. The policy, which adds to a contract that became effective last August, enhances access to the Pigmented Lesion Assay (PLA), the foundational assay for the company's DermTech Melanoma Test (DMT), which includes another gene, for the approximately 4.5 million members of the plan. DermTech's total of covered lives in the US is now approximately 133 million, including 68 million for Medicare/Medicare Advantage and 65 million for commercial and governmental payors. 

Virax Biolabs Group said this week that it inked a contract to launch a laboratory facility at the Scale Space research and innovation campus at Imperial College London. The firm said the site will be instrumental in the launch of its Virax Immune T-cell testing platform by providing the first laboratory for blood draw and analysis, and the laboratory will also let Virax fulfill third-party laboratory orders. 

Canadian medical technology firm Kenota Health said this week that it has submitted its Kenota 1 System and Kenota 1 Total IgE assay for US Food and Drug Administration review through the agency's dual 510(k) and CLIA-waiver pathway. The testing system is designed to provide quantitative IgE testing in allergy clinics. The Kitchener, Ontario-based firm said it completed its internal verification studies in 2022 and CLIA waiver studies in April 2023. Kenota is developing additional IgE allergen panels that it plans to submit for 510(k) clearance. 

Theradiag this week announced preliminary financial results for the first half of 2023, reporting that revenues grew nearly 7 percent to €6.7 million compared to €6.3 million in the same period in 2022. Sales in the firm’s Theranostics business rose 18 percent to €3.6 million from €3.0 million in 2022, partially driven by solid growth in France, the company said in a statement. Meantime, the firm's in vitro diagnostics business declined about 4 percent to €3.1 million from €3.2 million in the first half of 2022 as sales in this segment contracted in France. As of June 30, the company had cash and cash equivalents of €5.7 million. 

Bluejay Diagnostics said this week its board has approved a 1-for-20 reverse split of its common stock. The split is being implemented to ensure Bluejay complies with a Nasdaq listing requirement for a minimum $1 bid price for its stock, the Acton, Massachusetts-based firm said. The split will take effect at 12:01 a.m. on July 24. 

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.