Applied Extracts Inc., a San Mateo, Calif.-based manufacturer of scientific instruments, said that the company is in the process of developing an environmentally friendly sterilization technology with broad potential applications, including mitigating the spread of the coronavirus and other pathogens.
Arima Genomics Inc., of San Diego, reported the completion of customer validation and the full commercial launch of the Hichip application built on its existing Arima-Hic platform. With this launch, researchers can now obtain long-range chromatin interactions specifically enriched at genomic locations occupied by proteins of interest from a single experiment, enabling speed to discovery and publication with reduced costs.
Aytu Bioscience Inc., of Englewood, Colo., said that it intends to expedite the U.S. launch of its recently licensed COVID-19 IgG/IgM Point-of-Care Rapid Test in light of updated U.S. FDA policy on coronavirus diagnostic testing.
Franklin Lakes, N.J.-based Becton, Dickinson and Co. and Biogx Inc., a Birmingham, Ala.-based molecular diagnostics company, have submitted emergency use authorization requests to the U.S. FDA for new diagnostic tests that, if authorized, would increase the potential capacity to screen for COVID-19 by thousands of tests per day.
Blue Earth Diagnostics, an Oxford, U.K.-based subsidiary of Milan-based Bracco Imaging S.p.A., said that the first patient has been dosed in its multicenter, single-arm imaging phase III LIGHTHOUSE clinical trial of rhPSMA-7.3 (18F), an investigational Prostate Specific Membrane Antigen-targeted radiohybrid PET imaging agent. The primary objectives of the study are to assess the sensitivity and specificity of rhPSMA-7.3 (18F) PET for detecting pelvic lymph node metastases compared with surgical pathology on a patient level.
South San Francisco-based Caredx Inc. reported the launch of Remotrac, a solution enabling remote home-based monitoring of transplant patients. The company now will provide Remotrac, a remote home-based blood draw solution using mobile phlebotomy for Allosure and Allomap surveillance tests, as well as for other standard monitoring tests. By reducing visits to busy labs and hospitals, immunosuppressed transplant patients at the highest risk during the COVID-19 pandemic can limit their potential exposure.
Cefaly Technology, which has a U.S. presence in Wilton, Conn., reported a buyback program through which customers in the U.S. and Canada may return their original Cefaly 1 device and receive a discount off the purchase of a Cefaly Dual device.
Co-Diagnostics Inc., a Salt Lake City-based molecular diagnostics company, said that a new U.S. FDA policy aimed at expediting the availability of COVID-19 diagnostics will allow the company to aggressively expand its presence in the U.S. market.
Datos, a provider of an automated remote care platform that has a presence in New York and Ramat Gan, Israel, reported the availability of its telemedicine solution for remote monitoring of coronavirus patients.
Geacom Inc., of Duluth, Minn., said that it is deploying thousands of Phrazer/Kitsune devices to be used for COVID-19 triage and management in response to regional response centers need throughout the Upper Midwest. Phrazer/Kitsune devices are helping response centers manage patient intake by allowing self-triage in any language, eliminating exposure to medical staff and expediting the COVID-19 screening process.
Haselmeier, of Zurich, received Master File Number MAF3202 from the U.S. FDA for its D-Flex product platform, a new generation of injection pen systems for subcutaneous self-administration. A device master file provides regulatory authorities with proprietary data about a material, component or manufacturing process.
Healthcall LLC, of Crown Point, Ind., has launched its COVID-19 telehealth screening and monitoring application, with an eye toward helping paramedics care for more patients in less time.
Zurich-based Heiq Materials AG has launched Heiq Viroblock NPJ03, an antiviral and antimicrobial textile treatment tested effective against coronavirus.
San Diego-based Illumina Inc. is teaming up with IDbyDNA Inc., of San Mateo, Calif., to advance next-generation sequencing (NGS)-based workflows for the global microbiology market. Under the terms of the agreement, Illumina and IDbyDNA will each co-market IDbyDNA’s Explify platform for use with Illumina’s NGS systems and library preparation to streamline research use only workflows for infectious disease applications.
Impulse Dynamics Inc., of Mount Laurel, N.J., reported the first enrollment in a post approval study of its CCM therapy delivered by its Optimizer system. Cardiac contractility modulation therapy is a minimally invasive treatment for heart failure patients. The patient was enrolled at Southwest Cardiovascular Associates in Mesa, Ariz.
Invo Bioscience Inc., of Sarasota, Fla., said it has changed its trading symbol from IVOB to INVO. The company began trading under the new symbol on the OTC Markets on March 16, 2020.
Kadima, Israel-based Nobio Ltd. and Supergum (1983) Ltd., of Tel Aviv, are partnering to prototype and antiviral protective masks. The collaboration will combine Nobio’s antimicrobial technology and Supergum’s chemical, biological, radiological and nuclear breathing protection products to develop face masks to protect against various microbial pathogens, including COVID-19.
Golden, Colo.-based Pharmajet Inc. reported a $9.6 million award from the Joint Science and Technology Office of the U.S. Defense Threat Reduction Agency to advance development of its next-generation needle-free devices – part of a larger program to use needle-free technology to progress nucleic acid vaccines. Initial studies are focused on the delivery of Venezuelan equine encephalitis virus (VEEV) DNA vaccines developed by the U.S. Army Medical Research Institute of Infectious Diseases using Pharmajet’s systems.
Venlo, Netherlands-based Qiagen NV said it plans to significantly ramp up production capacity for RNA extraction kits for use in detecting the SARS-CoV-2 coronavirus – from its current production level of about 1.5 million patient tests per month to more than 6.5 million tests by the end of April and over 10 million tests by the end of June. The company also anticipates getting CE-IVD marking in the coming days for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test for the diagnosis of virus that causes COVID-19.
Roche Holdings AG, of Basel, Switzerland, said it began shipping an initial 400,000 COVID-19 test kits to laboratories across the U.S. on March 13, under an FDA emergency use authorization. That shipment will be completed this week, and the company plans to ship an additional 400,000 tests per week to combat the coronavirus outbreak.
San Diego-based Tandem Diabetes Care Inc. reported a security incident involving five employee email accounts and said it will be notifying customers of the breach. The company learned of the phishing incident on Jan. 17, 2020, whereby an unauthorized user gained access to an employee’s email account, which then compromised several other accounts, and has engaged a leading cybersecurity firm to assist in the investigation. The incident is not expected to significantly impact financial operations.
South San Francisco-based Twist Bioscience Corp. reported the availability of a next-generation sequencing target enrichment panel for SARS-CoV-2/COVID-19 research. The panels can be used for environmental monitoring and surveillance testing, as well as insights into full sequence information to track viral evolution and strain origin.
West China Hospital, an affiliate of Sichuan University located in Chengdu, China, has donated isothermal nucleic acid amplification microfluidic chip analyzers and nucleic acid test kits capable of detecting and distinguishing six respiratory virus, including COVID-19, to the government of Georgia. The donation was in response to a request from the Georgian embassy in China.
XCR Diagnostics Inc., of Salt Lake City, said it has completed verification and validation of its XCR (Xtreme Chain Reaction) COVID-19 assay and will petition the U.S. FDA for emergency use authorization. The company said its test provides results in about 30 minutes, vs. one to three hours for existing coronavirus tests.