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In Brief This Week: Invitae, Personalis, Seegene, Precipio, SkylineDx, and More

NEW YORK – Invitae said this week that it completed its acquisition of Singular Bio on June 19. The deal was announced June 17. At closing, Invitae issued about 2.5 million shares of its common stock and approximately $5.7 million in cash to the former security holders of Singular Bio. Part of the cash consideration is being held back to satisfy potential indemnification obligations. Following the merger, Invitae also granted $90 million of restricted stock units to the former employees of Singular Bio as an inducement to their continued employment by Invitae. The company will issue shares of its common stock to these employees based on time and milestone agreements.

Personalis said this week that it has closed its initial public offering of more than 9.1 million shares of its common stock at $17 per share. The underwriters exercised their option to purchase up to almost 1.2 million additional shares of Personalis' common stock. Net proceeds from the IPO are estimated to be approximately $140.8 million. The firm's stock began trading on the Nasdaq Global Market on June 20 under ticker symbol PSNL.

South Korean molecular diagnostics firm Seegene said this week that its nucleic acid extraction instrument, the Seegene Starlet, has been classified as a Class I device with the US Food and Drug Administration, and it will begin offering the tool and universal extraction cartridge kits in the US.

Precipio announced this week that it has initiated a second development project with H3 Biomedicine that will include the creation of a targeted gene panel, including a pre-amplification multiplexed PCR panel that will amplify targeted regions of the key genes of interest. 

The first project between H3 and Precipio involved the development of multiplexed PCR assays for the PIK3CA and ESR1 genes. The second development project between the companies will focus on the development of multiplexed PCR assays for FGFR3, PIK3CA, HRAS, TERT, and PLEKHS1. Precipio will also develop nine amplicons within the genes of interest and focus on the amplification and multiplexing of the mutations of interest. The panel could be used by H3 Biomedicine for its ongoing clinical development programs, according to Precipio.

Dutch diagnostics company SkylineDx said this week that it has been granted accreditation from the College of American Pathologists, following its CLIA certification in December 2018. During the CAP accreditation process, inspectors examined and audited the company's lab in San Diego, California to ensure that it met CAP's requirements for lab records, quality control procedures, staff qualifications, equipment, facilities and safety programs, SkylineDx said.

Exact Sciences announced this week that it has opened its new, 169,000-square-foot clinical laboratory and warehouse in Madison, Wisconsin. The laboratory will process the company's colorectal cancer screening test, Cologuard. The company said it expects the new facility to help bring its total Cologuard processing capacity to 7 million tests per year by the end of 2019 — 4 million tests per year at the new lab and 3 million per year at Exact's existing lab.

Moody's Investors Service has upgraded the unsecured rating of Bio-Rad Laboratories' senior unsecured notes from Baa3 to Baa2. Moody's said the upgrade reflects Bio-Rad's improvement in operating performance, including solid profit margin expansion, and the company's consistently strong credit metrics.

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

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.

Family Genetic Risk Score Linked to Diagnostic Trajectory in Psychiatric Disorders

Researchers in JAMA Psychiatry find ties between high or low family genetic risk scores and diagnostic stability or change in four major psychiatric disorders over time.

Study Questions Existence of Fetal Microbiome

A study appearing in Nature this week suggests that the reported fetal microbiome might be the result of sample contamination.

Fruit Fly Study Explores Gut Microbiome Effects on Circadian Rhythm

With gut microbiome and gene expression experiments, researchers in PNAS see signs that the microbiome contributes to circadian rhythm synchronicity and stability in fruit flies.