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In Brief This Week: BioReference Laboratories, PerkinElmer, Fluidigm, Invitae, and More

NEW YORK – Opko Health subsidiary BioReference Laboratories announced this week that it will provide COVID-19 testing to players, officials, and team and league staff of the National Basketball Association and the National Hockey League for their 2020-2021 seasons. BioReference has been providing testing at the NBA team facilities, and it will now provide testing for the 24 US-based teams in the NHL.

BioReference is also providing testing for the Winter X Games, US Soccer’s Men’s and Women’s National Teams, and the NBA G League.

PerkinElmer said this week it has joined the European Alliance for Newborn Screening in Spinal Muscular Dystrophy, or SMA NBS Alliance. Founded by SMA Europe, the alliance aims to shorten the length of time to diagnose a child born with SMA through newborn screening and to help patient advocacy groups accelerate the identification of such children. The alliance is pushing for the inclusion of SMA testing in all NBS programs in Europe for all newborn children by 2025. PerkinElmer's Eonis System is an RT-PCR newborn screening assay for the simultaneous testing of SMA, severe combined immunodeficiency, and X-linked agammaglobulinemia. It received the CE-IVD mark in September.

Also this week, PerkinElmer's board declared a regular quarterly dividend of $.07 per share, payable on May 7 to shareholders of record at the close of business on April 16.

Fluidigm said this week that Missouri-based CLIA laboratories Helix Specialty Diagnostics and Genomic LTC Dx are working together to provide COVID-19 testing using Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay on the Biomark HD system. As part of the collaboration, Helix Specialty Diagnostics will collect patient saliva samples while Genomic LTC Dx will process and analyze the samples using the Advanta assay. The partners intend to eventually deliver 3,000 tests per day to the region, the company said.

Fluidigm received Emergency Use Authorization from the US Food and Drug Administration for the Advanta test in August.

Invitae this week said it has closed a previously announced public offering of 8,932,038 shares of its common stock, which included the sale of 1,165,048 shares after underwriters fully exercised their option to purchase the additional shares. The shares sold at the public offering price of $51.50 per share, and the gross proceeds were approximately $460 million. The company said it will use the net proceeds for working capital and corporate expenses, to improve its platform and oncology and reproductive assays, and to expand internationally and acquire assets.

JP Morgan Securities, Morgan Stanley, Cowen and Company, and SVB Leerink acted as book-running managers, and William Blair & Company acted as co-manager for the offering.

CareDx said this week it has closed its previously announced public offering of common stock. The company sold 1,923,077 shares of stock at $91 per share. In addition, CareDx granted the underwriters a 30-day option to purchase up to 288,461 additional shares. The company expects net proceeds of approximately $164 million, which it plans to use for working capital and general corporate purposes.

Goldman Sachs and Jefferies acted as joint book-running managers for the offering. Raymond James, BTIG, Craig-Hallum Capital Group, and HC Wainwright acted as co-managers.

Aspira Women's Health this week announced that it has become a participating laboratory network provider for Highmark health insurance products in Pennsylvania and West Virginia. Highmark, an independent licensee of the BlueCross BlueShield Association, operates health insurance plans in Pennsylvania, Delaware, and West Virginia that serve more than 4.4 million members.

Aspira, formerly known as Vermillion, markets the OVA1 and OVERA tests, which detect the risk of ovarian malignancy in women with adnexal masses. Aspira said it increased the total in-network access for its tests in this past year to more than 154 million individuals.

Genetic Technologies this week said it has closed a previously announced $6.6 million direction offering of its American Depositary Shares (ADSs). 

The firm said it intends to use the net proceeds to support the introduction and distribution of new products in the US and Europe and for general product research and development and reimbursement studies for polygenic risk tests. Melbourne, Australia-based Genetic Technologies added that it further intends to use the net proceeds for implementation of its consumer-initiated testing platforms, preparation for its COVID-19 Severity Risk Test, the introduction of a germline genetic testing division, and for working capital and potential acquisitions.

HC Wainwright was the exclusive placement agent for the offering.

OraSure Technologies announced this week that UK-based biotechnology company Chronomics has selected the firm's OMNIgene ORAL saliva collection device as a component of its SARS CoV-2 PCR test. Chronomics will supply its test for a UK program called Test to Release for International Travel. The OMNIgene ORAL device is a product of OraSure's DNA Genotek subsidiary.

Interpace Biosciences said this week that its diagnostics group has signed a contract with Blue Cross Blue Shield of Florida. Interpace’s ThyGeNext and ThyraMir tests for indeterminate thyroid nodules will be adjudicated as in-network lab services for BCBS of Florida’s 5 million members, effective Jan 1.

SQI Diagnostics said this week that its fourth quarter revenues were down 50 percent year over year to C$300,000 ($234,000) from C$600,000 due to fewer sales of its platform and the negative effects of COVID-19. One of the Toronto-based company's customers temporarily suspended its operations, adversely affecting sales, it said. SQI also recorded lower service revenues in the recently completed quarter as a major customer delayed a project. The company posted a net loss of C$2.8 million, or C$.01 per share, for the three months ended Sept. 30, 2020, unchanged from a year ago. Its R&D spending was down 35 percent year over year to C$1.1 million from C$1.7 million in Q4 2019, while its SG&A costs more than doubled to C$1.8 million from C$800,000. SQI had cash and investments of C$2.6 million as of Sept. 30.

For its full fiscal-year 2020, the company's sales were down 44 percent to C$1.0 million from C$1.8 million. It had a net loss of C$8.6 million, or C$.03 per share, for the year compared to a net loss of C$8.0 million, or $.04, per share in 2019. Its R&D costs were trimmed 8 percent to C$4.6 million from C$5.0 million, and its SG&A costs grew 32 percent to C$4.1 million from C$3.1 million a year ago.

Eurofins this week reported preliminary FY2020 revenues of more than €5.4 billion ($6.54 billion), and said that its FY2020 organic growth rate was close to 20 percent. Despite the impact of further lockdowns in many countries, the company said its core business continued to demonstrate a quick return to long term growth rates. The company is also expecting to report a Q4 organic growth rate of 5 percent for its core business, excluding COVID-19 clinical reagents and testing revenues.

Eurofins will report its full Q4 and FY2020 results on March 1.

Becton Dickinson’s board of directors this week declared a quarterly dividend of $.83 per common share, payable on March 31 to holders of record on March 10. The indicated annual dividend rate is $3.32 per share.

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.