NEW YORK – ArcherDx announced this week that its next generation sequencing device to detect neurotrophic receptor tyrosine kinase (NTRK) gene fusions that lead to cancer received breakthrough device designation from the US Food and Drug Administration. The device is under development as a companion diagnostic and uses Anchored Multiplex PCR chemistry to capture DNA, RNA, or ctDNA from blood and tissue samples.
The firm said it is pursuing regulatory clearance so that the device can help with the underutilization of targeted therapies. The technology is designed for settings with a lack of genomic analysis infrastructure or expertise that can affect a physician's ability to select the best therapy for a patient, the company said.
Health insurer MagnaCare announced this week a collaboration with Opko Health's BioReference Laboratories to provide SARS-CoV-2 antibody testing to MagnaCare's labor union clients in New York. The company will offer on-site antibody blood testing to labor union members to help with strategies for returning employees to work.
The partnership started with on-site testing this week for District Council 9 of the International Union of Painters and Allied Trades, with costs fully covered by the union.
Antibiotic resistance diagnostics firm First Light Diagnostics said this week it has received a $1.1 million loan from the US Small Business Administration through the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The loan is part of a program to help US small businesses maintain their payrolls. The Chelmsford, Massachusetts-based company said that it closed its facility there in mid-March to obey a statewide emergency order. It furloughed about half of its employees and instructed the rest to work from home. As a result of the loan, First Light was able to return the furloughed employees onto its payroll on April 27 and has begun to implement a restart plan. The firm expects to have its facility ready to safely reopen in May.
Sherlock Biosciences said this week that the Open Philanthropy Project is advancing the firm $7.5 million in grant funding to launch the Sherlock Innovation Lab and accelerate the development of its at-home COVID-19 diagnostic utilizing its INSPECTR platform. Open Philanthropy awarded Sherlock Bio a $17.5 million non-dilutive grant to develop its SHERLOCK CRISPR platform when the company launched in 2019, and this $7.5 million has been released to the company earlier than expected to allow it to focus on developing its INSPECTR-based COVID-19 diagnostic, a company spokeswoman told GenomeWeb.
With the launch of the Sherlock Innovation Lab, the company is currently hiring industry and academic experts in synthetic biology to focus exclusively on scaling INSPECTR for at-home and low-resource environments.
Caris Life Sciences said this week that Rutgers Cancer Institute of New Jersey has become the 37th member of the Caris Precision Oncology Alliance, a collaborative network of cancer centers committed to precision medicine. The centers work together to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology, Caris noted. Rutgers Cancer Institute currently has 56 active clinical trials with a focus on precision medicine.
Toronto-based Datametrix AI said this week it has inked a strategic partnership and development deal with Transpharm Canada focused on Datametrix's COVID-19 testing kits. Datametrix will have access to Transpharm's 25,000-square-foot testing facility as part of the deal and will provide the kits while Transpharm will provide all other services, such as specimen collection and transport, and test processing. Transpharm will also develop a point-of-care diagnostic kit system. Financial and other terms were not disclosed.
Toronto-based diagnostics firm StageZero Life Sciences said this week that it has partnered with Boston-based laboratory testing software provider UDoTest to provide PCR-based and antibody testing for SARS-CoV-2. StageZero will connect primary care physicians to labs that provide COVID-19 testing through UDoTest’s online platform. UDoTest matches telehealth physicians and employers with labs that have SARS-CoV-2 tests that have received Emergency Use Authorization from the US Food and Drug Administration.
Macrogen said this week that it has obtained export approval for its Axen COVID-19 RT test kit from South Korea’s Ministry of Food and Drug Safety. Macrogen's test uses RT-PCR to detect SARS-CoV-2's ORF1ab and E genes to determine in about two hours whether a person is infected with the virus. The company is applying for Emergency Use Authorization from the US Food and Drug Administration and is seeking CE IVD marking.
Sona Nanothech said this week MRIGlobal will provide analytical and clinical validation studies for Sona's COVID-19 rapid detection, point-of-care, antigen test. The data will be used by Halifax, Nova Scotia-based Sona for submission to Health Canada for regulatory approval and the US Food and Drug Administration for Emergency Use Authorization.
Thermo Fisher Scientific said this week that its board of directors has declared a quarterly cash dividend of $.22 per common share, payable on July 15 to shareholders of record as of June 15.
Quest Diagnostics said this week its board of directors has declared a quarterly cash dividend of $.56 per share, payable on July 22 to shareholders of record on July 8.
Agilent Technologies this week declared a quarterly dividend of $.18 per share, payable on July 22 to shareholders of record at the close of business on June 30.
Luminex this week announced that its board of directors declared a quarterly cash dividend of $.09 per share, payable on July 9 to stockholders of record at the close of business on June 18.
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.