Ambu A/S, a Copenhagen-based manufacturer of diagnostics and life-support equipment, said the company was granted exemption from a two-week movement control order by Malaysian authorities aimed at limiting the spread of COVID-19 in the country. The control order went into effect March 18, 2020.
American Type Culture Collection Inc. (ATTC), of Manassas, Va., is expanding its support for U.S. and international R&D efforts in response to the COVID-19 pandemic and has developed three new quantitative synthetic SARS-CoV-2 RNA constructs for use as controls in the development and processing of molecular-based detection assays. One of the constructs, SARS-CoV-2 RNA: ORF, E,N, is compatible with World Health Organization-approved assays as well as the CDC SARS-CoV-2 detection assay. In addition, the company is expanding its collection of coronavirus standards to include SARS-CoV-2 genomic RNA and a heat-inactivated preparation from a strain sourced from an infected Washington State patient. The strain is fully sequenced and serves as a reference material for the U.S., the company said.
Irvine, Calif.-based Biomerica Inc. has begun shipping samples of its COVID-19 IgG/IgM Rapid Test to multiple health ministries and government agencies in Europe, the Middle East and elsewhere in the world. The fingerprick blood test yields results in 10 minutes and can be performed by trained professionals anywhere.
Bio-Techne Corp., of Minneapolis, said the U.S. General Services Administration has awarded its Exosome Diagnostics Laboratory an unlimited, 10-year reimbursement contract covering the ExoDx Prostate test for men. Effective March 18, 2020, the test will be available to more than 140 government entities, including the VA Healthcare system, U.S. military branches and the U.S. Congress.
Centogene AG, of Rostock, Germany, and Cambridge, Mass., said it will start testing for COVID-19, initially in the Mecklenburg-Western Pomerania region of Germany, with expansion to other geographies in the coming weeks.
Lund, Sweden-based Clinical Laserthermia Systems AB (CLS) reported that the University Hospital in Magdeburg, Germany, is assessing its magnetic resonance-guided, minimally invasive Tranberg clinical laser thermal therapy system for soft tissue in the treatment of small liver metastases and primary liver tumors. Twelve patients have been successfully treated with the MR-guided, laser interstitial thermal therapy procedure, with no treatment-related side effects. The mobile laser unit and disposables involved in the study are managed by CLS’ German subsidiary, CLS GmbH.
Dover Corp., of Downers Grove, Ill., has inked a definitive agreement to acquire Em-tec GmbH, of Finning, Germany, for an undisclosed sum. Following the close of the transaction, expected in the second quarter of 2020, Em-tec will become part of the PSG business unit within Dover’s pumps and process solutions segment.
Ann Arbor, Mich.-based Llamasoft Inc., a provider of artificial intelligence-powered supply chain analytics software, reported a comprehensive services offering to help companies restore operations affected by the novel coronavirus. The Llamasoft COVID-19 Response Center is a collection of llama.ai applications and services aimed at helping businesses adapt to rapidly changing supply chain situations and build resilience against future disruptions.
MeMD Inc., of Scottsdale, Ariz., is offering short-term telehealth options to help U.S. businesses manage health care needs during the COVID-19 crisis. Called Total Telehealth-Rapid Response, the new offering provides 90-day access to virtual telehealth services.
Myriad Genetics Inc., of Salt Lake City, said the National Comprehensive Cancer Network (NCCN) has updated its professional guidelines for prostate cancer to recommend biomarker-based testing for men with unfavorable intermediate or high-risk disease. Myriad’s Polaris test is one of just two prognostic tests recommended by NCCN for expanded indications.
Menlo Park, Calif.-based Pacific Biosciences of California Inc. said that the jury verdict in the U.S. District Court for the District of Delaware was not favorable overall for the company but mixed in terms of its findings. Although the jury sided with Pacific Biosciences in finding U.K.-based Oxford Nanopore Technologies Ltd. and its U.S. subsidiary Oxford Nanopore Technologies Inc. guilty of infringing the ’056, ’400, and ’323 patients, it declined to find these patents valid based on enablement. In addition, it went against the company with the ’056 patent in terms of written description and indefiniteness. The jury declined to find valid or infringed the ’929 patent also asserted by Pacific Biosciences in the actions. Pacific Biosciences intends to file post-trial motions with the court, seeking to overturn these aspects of the jury verdict and is also requesting a new trial, if warranted. In addition, if necessary, the company plans to appeal to the U.S. Court of Appeals for the Federal Circuit.
Parallax Health Sciences Inc., of Santa Monica, Calif., reaffirmed its plan to manufacture the company’s VT-1000 qualitative and quantitative immunoassay analyzer for medical use and has been cleared through a 510(k) with the U.S. FDA.
Qiagen NV, of Venlo, Netherlands, obtained derogation in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte for its Qiastat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic for the detection of SARS-CoV-2. At the same time, the company announced that the panel has received CE marking for Europe-wide sale as an in vitro diagnostic test to detect SARS-CoV-2.
Rewalk Robotics Ltd., of Yokneam, Israel, reported the finalization of an agreement with a group of German statutory health insurer to allow any eligible beneficiary with a spinal cord injury in the country to seek procurement of a Rewalk 6.0 exoskeleton system.
Startx, a nonprofit startup community of more than 1,500 Stanford, Calif.-based Stanford University faculty and alumni founders, reported the launch of its Startx Med COVID-19 task force and the mobilization of its medical companies providing solutions for the prevention, diagnostics and treatment of the novel coronavirus.
Tomi Environmental Solutions Inc., of Beverly Hills, Calif., has qualified to meet the EPA Emerging Viral Pathogen Guidance for Antimicrobial Pesticides with the Steramist Environment System for room fogging/misting against SARS-CoV-2, the novel coronavirus that causes COVID-19.
Tabula Rasa Healthcare Inc., of Moorestown N.J., has entered an agreement with Biointellisense Inc., of Denver, to distribute its Biosticker, the first FDA-cleared, single-use device enabling 30 days of continuous vital sign monitoring.
Columbia, Mo.-based Windgo Inc. has developed a networked sensor-verified light projection fixture that allows scheduled exposure of programmable light wavelengths. The system provides smart sensors and network communicating projectors that can attack the physical structure of biological material, such as viruses.