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In Brief This Week: CareDx, FDA, Oncocyte, and More

NEW YORK – CareDx said this week that it has entered into a strategic agreement with OrganX to develop clinical decision support tools for transplant patients. The companies are planning to create advanced analytics that integrate CareDx’s dd-cfDNA assay AlloSure with large transplant databases to provide clinical data solutions.

Last week, CareDx announced that it had closed a minority investment for an undisclosed amount in Miromatrix, a biotechnology company developing implantable engineered biological organs. CareDx and Miromatrix have also agreed to collaborate on certain research and development activities using CareDx technology, the company said. Through its proprietary perfusion decellularization and recellularization technology, Miromatrix is developing fully implantable human organs including livers and kidneys.


The US Food and Drug Administration this week issued an update to Mesa Biotech’s Accula SARS-CoV-2 test, saying the assay could be affected by a genetic mutation at positions 28877-28878 (AG to TC) in patient samples. The FDA provided the update out of “an abundance of caution” as the impact does not appear to be significant. It previously published information about an impact to the test’s performance resulting from a genetic mutation at positions 28881-28883 (GGG to AAC).


Oncocyte said this week that it has signed an agreement with Qiagen to support the launch of sotorasib (Amgen's Lumakras) through Qiagen's "Day One" lab readiness program, which is designed to expedite patient access to Qiagen companion diagnostic tests following regulatory approval of the tests and associated drugs. Last week, sotorasib received US Food and Drug Administration approval for previously treated, locally advanced, or metastatic non-small cell lung cancer patients whose tumors harbor a KRAS G12C mutation. It was approved alongside Qiagen's Therascreen KRAS RGQ PCR kit, a tissue-based companion diagnostic, and Qiagen selected Oncocyte as a "Day One" lab that will offer the assay. Oncocyte noted that the Qiagen tissue test complements its own DetermaRx assay for early-stage NSCLC patients, as well as its DetermaTx and DetermaIO tests for later-stage patients, which the company plans to launch in the second half of this year.


Myriad Genetics this week said it has completed the sale of its myPath melanoma test and the lab in which the test is performed to Castle Biosciences. Utah-based Myriad had announced in April that it planned to sell these assets to Castle for $32.5 million in cash, as part of a broader restructuring plan. The sale was finalized on May 28.


Singular Genomics Systems said this week that it has closed its initial public offering, raising $258 million in gross proceeds. The underwriters fully exercised their options to purchase approximately 1.5 million additional shares at the offering price of $22.00 per share.


TetraScience announced this week that it has entered into a strategic partnership with Thermo Fisher Scientific to integrate the Thermo Scientific Momentum Workflow Scheduling Software with the Tetra Data Platform. The centralized platform allows scientists to automatically collect, centralize, and harmonize life sciences R&D data in the cloud to accelerate drug discovery and research. The integration of the two technologies will combine Thermo Fisher’s bidirectional instrument control and increased automation readiness with the cloud-native architecture of Tetra Data Platform, Tetra said.


ERS Genomics said this week that the Japanese Patent Office has rejected arguments filed in opposition to the second CRISPR-Cas9-related Japanese patent (JP6692856) filed by Emmanuelle Charpentier, the regents of the University of California, and University of Vienna. The patent covers compositions and methods for use in a variety of eukaryotic cells, in either dual-guide or single-guide format. In addition, the patent office has allowed a third patent (JP2019-210828), which covers a chimeric version of the Cas9 protein.


Germany-based spatial analysis firm Resolve Biosciences said this week that it has opened a North American facility in San Jose, California.


Vienna, Austria-based omics firm Lexogen said this week it has received ISO 9001:2015 certification from TÜV Austria CERT for its quality-management system, which encompasses the research, development, and production of RNA analysis solutions, and the provision of bioinformatics products and services for RNA analysis. ISO 9001:2015 is a globally recognized quality management standard developed and published by the International Organization for Standardization.


PamGene International said this week that it has received an extension of its ISO 13485:2016 certification. The company said that the extension, which includes manufacturing, is an important component of its provision of in vitro diagnostic assay services for the prediction of immunotherapy response in oncological diseases using its IOpener kinome-activity profiling liquid biopsy tests. PamGene obtained its initial ISO certification in January 2019.


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

The Scan

Renewed Gain-of-Function Worries

The New York Times writes that the pandemic is renewing concerns about gain-of-function research.

Who's Getting the Patents?

A trio of researchers has analyzed gender trends in biomedical patents issued between 1976 and 2010 in the US, New Scientist reports.

Other Uses

CBS Sunday Morning looks at how mRNA vaccine technology could be applied beyond SARS-CoV-2.

PLOS Papers Present Analysis of Cervicovaginal Microbiome, Glycosylation in Model Archaea, More

In PLOS this week: functional potential of the cervicovaginal microbiome, glycosylation patterns in model archaea, and more.