Anpac Bio-Medical Science Co. Ltd., which has a presence in Shanghai and San Jose, Calif., said it has been validating a COVID-19 antibody test for commercial use in its San Jose, Calif.-based lab since the second quarter, with expected validation completion in the second half of the year.
BBS-Bioactive Bone Substitutes plc, of Oulu, Finland, has received an offer and a draft contract concerning handling of application for CE marking of Artebone Paste product, company’s ISO 13485 certification and related audits from notified body BSI. The company has approved the offer and contract, but the contract includes new requests of documents. The company is preparing these documents. Upon completion, it is ready to submit technical documentation related to the application of CE marking to the notified body.
Billerica, Mass.-based Bruker Corp. reported a collaboration with Utrecht University to advance the study of the 3D structures and interactions of proteins by mass spectrometry. The collaborative work will focus on the development of Trapped Ion Mobility Spectrometry and Parallel Accumulation Serial Fragmentation methods, along with crosslinkers and XL-MS software for the Timstof Pro 4D-Proteomics mass spectrometer.
Vaughan, Ontario-based Establishment Labs Holdings Inc. entered a definitive agreement with its Italian distributor to transition to a direct sales force in that market, effective Aug. 1. Under the terms of the agreement, Orion Trading srl, the Motiva distributor in Italy, will terminate its distribution arrangement with Establishment Labs and pay all outstanding balances due. Establishment Labs will acquire all product inventory and customer relationships in Italy for about $1.1 million. The net financial impact of these transactions to Establishment Labs is expected to be minimal.
Mdxhealth SA, of Herstal, Belgium, reported that Palmetto GBA, a Medicare administrative contractor, has requested an update to the technical assessment under the Molecular Diagnostic Services (moIDX) program for Medicare coverage of its Selectmd prostate cancer test. Palmetto GBA first issued a draft local coverage determination recommending coverage for the test in August 2019.
Tokyo-based Olympus Corp. has signed a definitive agreement to acquire Arc Medical Design Ltd., of Leeds, U.K., a subsidiary of Amsterdam-based Norgine BV. Under the agreement, Olympus will obtain Arc Medical Design and the full rights to its suite of products. Olympus will convert exclusive distribution rights of Endocuff Vision to a full acquisition of the Endocuff line of products, as well as Wide-Eye Polytrap and several products currently in development. Financial terms of the transaction were not disclosed.
Senseonics Holdings Inc., of Germantown, Md., said Highmark Inc., a Pittsburgh-based health insurance company, will provide coverage for its Eversense continuous glucose monitoring system, beginning Sept. 28, 2020.
Calgary, Alberta-based Sparta Group has inked an agreement with Sbl Technologies Inc., of both Calgary and Austin, to supply rapid COVID-19 antibody testing to the trucking industry.
Todos Medical Ltd., of Rehovot, Israel, reported sales of more than $550,000 for COVID-19 tests in the month of July. Sales were driven by 3D Med Andis auto-extraction machine and 3D Med RNA extraction reagent purchases by U.S. CLIA laboratories ramping up RT-PCRR testing capacity.