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In Brief This Week: Illumina, Myriad Genetics, Sonic Healthcare, and More

NEW YORK – The US Food and Drug Administration this week granted Illumina an amendment to its Emergency Use Authorization for COVIDSeq, authorizing the test to be run on the NextSeq line of instruments and with an additional flow cell option on the NovaSeq platformThe next-generation sequencing-based diagnostic test is now authorized to run on the NextSeq 500, 550, and 550 Dx systems. It was initially authorized to run on the NovaSeq 6000 with the S4 flow cell; now, the SP flow cell — which allows smaller run sizes — is also enabled. 

Illumina said that the amendment increases the installed base upon which the assay can run, and that the newest version of the assay uses a simplified workflow with an automation-friendly RNA extraction process, adding Dragen bioinformatics pipelines for the test to BaseSpace Sequence Hub.

Myriad Genetics said this week that that the American Society of Clinical Oncology (ASCO) has included Myriad's myChoice CDx test in its new recommendations on the use of PARP inhibitors for the treatment and management of certain patients with advanced ovarian cancer. The new recommendations were published recently in the Journal of Clinical Oncology.

Myriad said myChoice CDx was the only named commercial companion diagnostic in the ASCO guidelines, which stated that women with ovarian cancer and germline or somatic mutations in BRCA1 or BRCA2 and/or genomic instability, as determined by Myriad myChoice CDx, are recommended by ASCO for PARP inhibitor therapy.

Australian laboratory company Sonic Healthcare reported this week that total underlying revenues for its fiscal year 2020 ended June 30 grew more than 11 percent year over year to A$6.8 billion ($4.8 billion), and its net profit grew to A$552 million. The company, which has operations in Australia, Asia, the US, and Europe, said it has performed about 6 million COVID-19 PCR testsand will continue to increase testing capacity to meet the needs of the countries in which it operates.

The company said that after a strong first half of the year, it experienced significant drops in base business patient volumes from mid-March through May as a result of social restrictions stemming from the coronavirus pandemic, as well as patients' fears of becoming infected with SARS-CoV-2. However, the company added, its base business volumes largely recovered by June 30, and COVID-19 testing volumes partially offset the decrease. Further, Sonic added, revenues growth rates have been higher than usual since the end of the year, though the firm also noted that it can't be sure how long those growth rates will continue.

Fujifilm Medical Systems said this week that it will integrate Fujifilm Wako Diagnostics into its business, effective Oct. 1. As a result, Fujifilm Wako's portfolio of in vitro diagnostic products will be added to Fujifilm Medical's product offerings. Wako Diagnostics was originally acquired by Fujifilm Corp. in 2017 and has been operating as a separate subsidiary. It has a portfolio of biomarkers for assessing the risk of developing hepatocellular carcinoma in patients with chronic liver disease, and its solutions include IVD reagents and systems for lipid metabolism, lupus, rheumatoid arthritis, coronary heart disease, and diabetes. The new IVD group will be led by Hidetoshi Izawa, vice president of modality solutions and clinical affairs for Fujifilm Medical Systems.

4basebio, formerly Expedion, said this week that it intends to spin off its whole operating business, namely its genomics and DNA manufacturing business, into a UK-based separate company to be listed on the Alternative Investment Market, a submarket of the London Stock Exchange.

4basebio — which currently trades on the Frankfurt Stock Exchange and is headquartered in Heidelberg, Germany with an office in Cambridge, UK — said it is considering retaining a significant minority stake in the new entity and distributing the remaining shares to its existing shareholders. As part of this process, the spinoff will be suitably capitalized from 4basebio's existing cash, and 4basebio's management board would join the board of the spinoff and assume responsibility for its day-to-day operation. The company intends to complete this process by Dec. 31.

Todos Medical said this week that it has entered into a sales agreement with a New York-based laboratory to supply it with testing equipment and supplies to perform up to 3,000 qPCR tests per day. Todos said the sales contract is worth approximately $1 million per month for six months, and that it could supply up to 30,000 tests per day if demand increases for the lab.

Interpace Biosciences said this week that it received a notice from the Nasdaq indicating that the company no longer satisfies Nasdaq's listing rule 5250(c)(1) due to its delay in filing Form 10-Q for itsecond quarter resultsThe deficiency does not have an immediate effect on Interpace’s listing or on its common stock on the Nasdaq.

Quest Diagnostics announced this week that its board of directors has declared a quarterly cash dividend of $.56 per share, payable on Oct. 21 to shareholders of record on Oct. 6.

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.