Amc Health, of New York, said that its expanded and longstanding relationship with Evicore Healthcare, of Bluffton, S.C., will include new interactive voice response solutions designed to help assess, monitor and triage support for patients who are living with underlying conditions and are at the greatest risk of COVID-19 and respiratory symptoms. In addition to Amc’s ongoing telehealth services for hospitals, health plans and veterans, launching and expanding these solutions will aim to ensure that high-risk patients can be monitored at-home.
Archerdx Inc., of Boulder, Colo., and Premier Inc., of Charlotte, N.C., signed a two-part agreement, kicking off a multiyear program. Premier Applied Sciences will identify eight to 10 member institutions that will implement Stratafide in a research-use only capacity to participate in a retrospective study to evaluate its sequencing performance in comparison to other diagnostic tests. Archerdx plans to seek approval from the U.S. FDA for Stratafide as a genomic sequencing in vitro diagnostic cancer assay capable of analyzing both tissue and blood samples. The goal of the partnership is to help solve for the underutilization of targeted therapies in late-stage cancer patients.
Centogene AG, of Rostock, Germany, reported the production and global distribution of Centoswab. This sample collection kit is fully validated for pharyngeal sampling in the detection of SARS-CoV-2. Manufactured in Germany, the kit consists of a sterile package containing a swab and collection tube.
Cerus Corp., of Concord, Calif., reported an amendment to the company’s contract with the Biomedical Advanced Research and Development Authority. The amendment provides an additional $14 million in available funding, increasing the total potential value of the contract to $214 million. The $14 million contract amendment includes additional funding for Redes, the ongoing phase III U.S. clinical study evaluating the safety and efficacy of Intercept red blood cells in patients receiving transfusions in the acute and chronic setting. In addition, the contract expansion provides funding to further evaluate the efficacy of the Intercept Blood System to inactivate SARS-CoV-2 in all three blood components beyond what has already been established for the inactivation of other coronaviruses.
San Diego-based Kurin Inc. has won a contract with performance improvement company Vizient Inc., of Irving, Texas, for its Kurin Lock blood culture optimization device to reduce contamination rates. The agreement offers Vizient members negotiated pricing and terms.
Opgen Inc., of Gaithersburg, Md., reported a collaboration between its subsidiary, Curetis GmbH, of Holzgerlingen, Germany, and Karolinska Institutet, of Solna, Sweden, to identify bacterial co-infections in patients admitted to the intensive care unit for COVID-19 pneumonia using the company’s Unyvero Hospitalized Pneumonia panel. The panel detects 21 clinically relevant pathogens and 17 antibiotic resistance markers in less than five hours from samples with just two minutes of hands on time.
Oxford Immunotec Global plc, of Oxford, U.K., said it has reregistered its T-Spot.TB test with China’s National Medical Products Administration.
Los Angeles-based Science 37 Inc. and Advarra Inc., an institutional review board (IRB) headquartered in Columbia, Md., have teamed up to accelerate approvals of COVID-19-related virtual trials. The partnership leverages Advarra’s IRB reviews and quick turnaround times with Science 37’s proprietary platform and virtual trial expertise.
Simplify Medical Pty. Ltd., of Sunnyvale, Calif., said it has completed the PMA submission to the U.S. FDA for its 1-Level Simplify Disc IDE clinical trial. The prospective, multicenter study evaluated the Simplify Disc for 1-level cervical implantation between C3 and c7 vertebrae, compared with historical fusion control. The device, which is CE marked in Europe, is being assessed in a separate U.S.-based IDE trial for 2-level procedures.