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In Brief This Week: FDA, Caris Life Sciences, SeqBiome, and More

NEW YORK – The US Food and Drug Administration announced this week that it has revoked its umbrella pathway for COVID-19 serology assays. The agency said the pathway had been an internal administrative move that was meant to streamline the Emergency Use Authorization process, but that looking at each application individually has turned out to be more efficient. No device was ever authorized under the pathway, the FDA said in letter to manufacturers.

Caris Life Sciences this week said that Montefiore Health System has become the 39th member of the Caris Precision Oncology Alliance, a collaborative network of cancer centers that demonstrate a commitment to precision medicine. Through the alliance, Montefiore will partner with other notable cancer centers and academic institutions to broaden patient access to precision cancer care, have early access to Caris MAI (Molecular Artificial Intelligence) offerings, and establish evidence-based standards for cancer profiling and molecular testing in oncology.

APC Microbiome Ireland, SFI Research Centre, University College Cork, and Irish Agriculture and Food Development Authority Teagasc said this week that they’ve founded a spinout company called SeqBiome. According to UCC Innovation, the technology transfer office of University College Cork, the new firm has support from Enterprise Ireland, UCC, APC, and Teagascand is providing sequencing and microbiome analysis services for academia and industry. It has already signed collaboration deals with a number of customers and partners, including Nestle, Mars Petcare, Atlantia, the Alpinia Institute, Microbion, and the PrecisionBiotics group.

Genetic Technologies this week said it has closed its previously announced direct offering of 1,025,000 American Depositary Shares. Each ADS represents 600 shares of the Australian company’s common stock. At a purchase price of $5 per ADS, the offering raised gross proceeds of about $5.1 million.

The COVID-19 Host Genome Structural Variant Consortium, led by Ravindra Kolhe of Augusta University, announced plans this week to analyze at least 1,000 genomes with Bionano Genomics' Saphyr optical mapping platform. The consortium includes researchers from Baylor College of Medicine, Harvard University, Children’s National Medical Center, Columbia University, George Mason University, MD Anderson Cancer Center, the National Cancer Institute, Oregon Health and Science University, Rockefeller University, San Francisco State University, Sanford Burnham Prebys, UC San Diego, UC Santa Cruz, and Virginia Commonwealth University.

Chromosome Medicina Genômica said this week that it is introducing LifeView PGT-P (Preimplantation Genetic Testing for Polygenic disease) to Brazil in partnership with Genomic Prediction and Diagnosticos da America (DASA)Developed by North Brunswick, New Jersey-based Genomic Prediction, LifeView PGT-P is a genetic screening test that can assess an embryo’s risk of common diseases such as diabetes, common cancers and heart diseases, and mental disorders such as schizophrenia. Embryos can be screened for one condition, several conditions, or all available conditions which can then be ordered from lowest to highest risk. The method is validated to reduce disease incidence, Genomic Prediction said. Brazil's first couple to elect this testing is currently under the care of Ciro Martinhago, clinical laboratory director of Chromosome Medicina Genômica, DASA’s reproductive genetics testing laboratory.

Grifols announced this week that it has acquired 10 percent of Bloodbuy, a cloud-based marketplace that facilitates the buying and selling of blood components in the US. Bloodbuy’s technology platform and computer-based algorithms enable regional blood-collection centers to expand their customer base, Grifols said. The technology provides access for hospitals and other healthcare providers to vital blood components in an efficient manner.

Bloodbuy’s marketplace is available to qualified hospitals, medical centers, integrated delivery networks, and blood-collection centers. Along with the equity investment, Grifols will obtain a seat on Bloodbuy’s board of directors.

PerkinElmer said this week that its board has declared a regular quarterly dividend of $.07 per share of common stock, payable on Nov. 6 to shareholders of record at the close of business on Oct. 16.

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.