In Brief This Week: Quantum-Si, TGen, Yale, and More – GenomeWeb

NEW YORK Quantum-Sisaid this week that it has completed itsplanned mergerwith special purpose acquisition firmHighCapeCapital Acquisition.

The business combination and private placement, approved byHighCape'sstockholders 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 millionincash held inHighCape'strust account and $425 million from private placementinvestors, includingForesiteCapital Management, Eldridge, accounts advised by ARK Invest, and Glenview Capital Management. Also, QSi's management team and existing stockholders have rolledall oftheir equity into the combined company.

Following the merger, thecombinedfirm 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 ofHighCapeClass A common stock and Class B common stock became one share of the combined company's Class A common stock.

The Translational Genomics Research Institute said this week that it has received a "substantial grant" from Taiwan Semiconductor Manufacturing 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.

The US Food and Drug Administration this week reissued a letter granting Emergency Use Authorization to the Yale School of Public Health for itsSalivaDirectSARS-CoV-2 test.

In its letter, the FDA authorized use of the test with additional thermocyclersABIStepOneReal-Time PCR System, ABI Prism 7000 Real-Time PCR System, ABIQuantStudioDx,UbiquitomeLiberty16, Roche Cobas Z480, and Analytik JenaqTower. Based on a post-authorization asymptomatic screening study, the agency also removed a limitation on serial testing for asymptomatic screening.

The FDAhadgranted EUAto Yale fortheSalivaDirecttestin August 2020.

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 agencys 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 cant commit to a timeline. OpGen previously submitted its Acuitas panel to the FDAin May 2019,and the agency has twice requested more information.

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 companys 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.

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 Yourgenes Flex Analysis Software and commits Yourgene to supplying sample preparation reagents and instrumentation to support the precision medicine companys 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 werent disclosed.

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.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared onGenomeWeb.

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In Brief This Week: Quantum-Si, TGen, Yale, and More - GenomeWeb