NEW YORK – OpGen announced this week that it has submitted an updated 510(k) summary document to the US Food and Drug Administration for its Acuitas AMR Gene Panel for Isolates. The updated document includes the agency’s requested updates to documents such as the package insert, electronic user guide, and operator manual. The agency provided feedback on the documents by the end of May and told OpGen it intends to finish its review by August, but that it can’t commit to a timeline. OpGen previously submitted its Acuitas panel to the FDA in May 2019, and the agency has twice requested more information.
The US Food and Drug Administration this week reissued a letter granting Emergency Use Authorization to the Yale School of Public Health for its SalivaDirect SARS-CoV-2 test.
In its letter, the FDA authorized use of the test with additional thermocyclers — ABI StepOne Real-Time PCR System, ABI Prism 7000 Real-Time PCR System, ABI QuantStudio Dx, Ubiquitome Liberty16, Roche Cobas Z480, and Analytik Jena qTower. Based on a post-authorization asymptomatic screening study, the agency also removed a limitation on serial testing for asymptomatic screening.
The FDA had granted EUA to Yale for the SalivaDirect test in August 2020.
ProPhase Labs this week announced the formation of two wholly owned subsidiaries, ProPhase Precision Medicine and ProPhase Global Healthcare. The precision medicine subsidiary will focus on genomic testing technologies and will look to acquire existing businesses and technologies or otherwise gain access to technologies used in whole-genome sequencing, the company said. The global healthcare business will expand the company’s COVID-19 testing into other countries and will develop additional healthcare-related initiatives, ProPhase added. The company is also developing SARS-CoV-2 antigen and antibody tests to add to its offerings.
India-based Core Diagnostics said this week that it has received accreditation from the College of American Pathologists for a range of tests, including cardiology, oncology, endocrinology, infectious diseases, gynecology, and nephrology. In the accreditation process, CAP inspectors examined the firm's clinical laboratory records and quality control procedures for the past two years. The inspectors also examined Core Diagnostics' laboratory staff qualifications, equipment, facilities, safety program and record, and overall management.
The Translational Genomics Research Institute said this week that it has received a "substantial grant" from Taiwan Semiconductor Manufacturing, or TSMC, to support SARS-CoV-2 variant tracking. Arizona-based TGen will use the funding to perform genomic sequencing of virus samples. The institute is under contract with the Arizona Department of Health Services and the Centers for Disease Control and Prevention to sequence samples from patients who have tested positive for SARS-CoV-2 in Arizona and to monitor for the emergence of mutations and variants. TSMC is building a chip manufacturing plant in north Phoenix that is expected to begin production in 2024.
Quantum-Si said this week that it has completed its planned merger with special purpose acquisition firm HighCape Capital Acquisition.
The business combination and private placement, approved by HighCape's stockholders on June 9, provide the company with approximately $534 million in funding, prior to transaction fees, for further development and commercialization of its single-molecule, semiconductor chip-based protein sequencing and genomics technology. This includes approximately $109 million in cash held in HighCape's trust account and $425 million from private placement investors, including Foresite Capital Management, Eldridge, accounts advised by ARK Invest, and Glenview Capital Management. Also, QSi's management team and existing stockholders have rolled all of their equity into the combined company.
Following the merger, the combined firm was renamed Quantum-Si. Its Class A common stock and warrants will begin trading on the Nasdaq Global Market on June 11 under the symbols QSI and QSIAW, respectively. Former Quantum-Si stockholders exchanged their shares of capital stock for common stock of the combined company at an exchange ratio of 0.7975. Each share of HighCape Class A common stock and Class B common stock became one share of the combined company's Class A common stock.
Abbott announced this week that its board of directors declared a quarterly common dividend of $.45 per share. The dividend is payable August 16 to shareholders of record at the close of business on July 15.
Yourgene said this week that it has entered into a license and supply agreement with an unnamed US precision medicine company for an initial term of three years, starting April 1, 2022. The agreement grants the precision medicine company a nonexclusive license to Yourgene’s Flex Analysis Software and commits Yourgene to supplying sample preparation reagents and instrumentation to support the precision medicine company’s planned launch of a new clinical reproductive health screening service across the US. The deal also allows for automatic annual renewals after the initial term. Financial terms were not disclosed.
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.