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In Brief This Week: Grail, Illumina, Veracyte, Aspira Women's Health, and More

NEW YORK – Liquid biopsy firm Grail posted a net loss for the third quarter of fiscal year 2020 of $80.4 million, or $.58 per share, compared to a net loss of $60.7 million, or $.49 per share, in the prior-year period, according to documents filed last week with the US Securities and Exchange Commission by Illumina. Illumina is planning to acquire Grail for approximately $8 billion in cash and stock.

Grail's R&D expenses for the quarter totaled $48 million, up 23 percent from $39 million in the prior-year period. Marketing, general, and administrative expenses rose 30 percent to $33.2 million from $25.6 million. As of Sept. 30, 2020, Grail had $166.8 million in cash and cash equivalents and $465.7 million in short-term marketable securities.

Illumina also provided pro forma 2020 financial results for a combined entity, assuming the merger had happened right before the beginning of the fiscal year. In 2020, Illumina's actual net income was $656 million, or $4.45 per share. In its pro forma combined balance sheet, Illumina would have had net income between $399 million and $423 million, or between $2.54 and $2.66 per share, depending on how Grail shareholders select additional consideration in the proposed merger.

Separately, Grail said this week that it will work with AccessHope, a company that provides cancer expertise to employers and their healthcare partners, to coordinate with patients and physicians alongside its Galleri cancer screening test when it launches it later this year. AccessHope will provide various services, including access to a patient support team for guidance and information during the test process, as well as resources for physicians as they determine next steps to evaluate a positive Galleri test result. Financial terms of the agreement were not disclosed.

Galleri, which will require a prescription, will be made available initially only through partner health systems, medical practices, and self-insured employers. Grail previously said it plans to launch the test in the second quarter of 2021.


Aspira Women's Health said this week that its wholly owned subsidiary Aspira Labs has been credentialed with the New York State Medicaid program for an additional 6.5 million Medicaid lives. As a result, the program will begin covering the company's OVA1 test on April 1, bringing the total coverage for the test to 179 million nationwide. The US Food and Drug Administration-cleared test is for the evaluation of ovarian cancer risk for women with a pelvic mass.


Veracyte said this week that it has completed its acquisition of Decipher Biosciences. Tina Nova, formerly president and CEO of Decipher, has been appointed as general manager of urological cancers at Veracyte.


Prometheus Biosciences said this week that it has closed its initial public offering of 11.5 million shares of its common stock at $19 per share, including 1.5 million shares purchased by the offering's underwriters when they exercised their option in full. Aggregate gross proceeds from the offering were $218.5 million, the San Diego-based firm said. SVB Leerink, Credit Suisse, Stifel, and Guggenheim Securities acted as joint bookrunning managers for the offering.


DiamiR this week announced a definitive agreement to acquire a CLIA-certified laboratory from Interpace Biosciences. Financial and other terms of the deal, which is expected to close by the end of April, were not disclosed. The lab is located in New Haven, Connecticut. DiamiR said that the lab will expand its own ability to develop and commercialize its microRNA-based tests for the early detection, differential diagnosis, prediction of progression, and monitoring of brain health and other illnesses.


Genetics and specialty diagnostics lab Agiomix said this week it has received ISO 15189:2012 accreditation for its next-generation sequencing-based clinical assays from the Emirates International Accreditation Centre. United Arabs Emirate-based Agiomix said it is the only clinical lab in the region to be ISO- and College of American Pathologists-accredited for NGS-based clinical testing.


Bio-Techne this week said that its Bristol, UK-based site received ISO 9001:2015 Quality Management Systems certification, an internationally recognized quality standard to ensure the consistent design, development, production, and sale of products that are fit for purpose as per the intended use. The certification provides additional assurances to its customers that key components of its processes are consistently designed and manufactured to meet their requirements, the firm said. Bio-Techne's Bristol facility produces life science reagents for research use.


Agilent Technologies said this week that its board has approved a quarterly dividend of 0.194 cents per share of common stock, payable on Apr. 28 to all shareholders as of the close of business on Apr. 6.


In a prospectus filed this week with the US Securities and Exchange Commission, Chembio Diagnostics said that that it may offer and sell from time to time in one or more offerings up to $100 million in the aggregate of its common stock, preferred stock, debt securities, warrants, and units. The prospectus is part of a registration statement filed with the SEC.


Amoy Diagnostics and Haihe Biopharma recently announced that they have inked an agreement to use the AmoyDx MET mutation detection kit as a companion diagnostic assay to support the registration of Haihe’s MET kinase inhibitor Glumetinib (SCC244) in the US.

Under the terms of the agreement, AmoyDx will develop and register the AmoyDx MET Mutation Detection Kit in the US with the aim of obtaining an FDA premarket approval to use it as a c-MET exon14 skipping CDx for Glumetinib (SCC244), which is a MET kinase inhibitor that targets c-MET exon14 skipping alterations in people with non-small cell lung cancer.


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.