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In Brief This Week: Enzo Biochem, Personalis, MDxHealth, IntegraGen, and More

NEW YORK (360Dx) – Enzo Biochem and its subsidiary Enzo Life Sciences announced this week that the Patent Trial and Appeal Board has denied a petition filed by Hologic for inter partes review, a procedure for challenging the validity of patent claims, against US Patent 6,221,581. Enzo Life Sciences is asserting the patent in infringement litigation against Hologic, Grifols Diagnostic Solutions, and Grifols SA in the US District Court for the District of Delaware.


Personalis said this week that the College of American Pathologists has reaccredited the firm's clinical laboratory in Menlo Park, California. The lab was first accredited in 2014. During the accreditation process the lab’s records and quality control procedures for the preceding two years are examined by inspectors. They also reviewed lab staff qualifications, equipment, facilities, safety programs and records, and overall management.


MDxHealth announced this week that its ConfirmMDx prostate cancer test has been included in the 2018 European Association of Urology (EAU) guidelines. The EAU guidelines assist clinicians in making informed treatment decisions, and the inclusion of ConfirmMDx in the guidelines will facilitate adoption of the test in EU member state-specific guidelines, the firm said.


IntegraGen said this week that it has earned ISO 13485:2016 certification from Bureau Veritas. The certification indicates that the company’s quality management systems meet specific standards required for the design, development, production, and marketing of in vitro diagnostic kits. It also demonstrates IntegraGen’s commitment to a proper industrial approach by adopting international quality standards, the firm said.


Becton Dickinson’s board this week declared a quarterly dividend of $.75 per share, payable on June 29 to shareholders of record on June 8. The indicated annual dividend rate is $3 per share, the firm said. The board also declared a quarterly dividend of $15.31 per share on the 6.15 percent mandatory convertible preferred stock, Series A, payable on Aug. 1 to shareholders of record on July 15.


Quotient announced this week that the US Food and Drug Administration approved seven of its blood-bank reagents. The products include four monoclonal antisera reagents and three anti-human globulin reagents. The firm noted that anti-human globulin is an essential tool for laboratories responsible for blood transfusion, and its ALBAclone monoclonal antisera are used in the lab to detect the presence of specific antigens on patient and donor red blood cells. Bill Brady, vice president of US commercial at Quotient Biodiagnostics, said in a statement that the reagents are an addition to its line of reagent red cells, ABO/Rh reagents, antisera, quality controls, and specialty products.


Spanish healthcare and life sciences firm Werfen this week reported its total revenues for 2017 increased 13 percent year over year to €1.34 billion ($1.62 billion). Hemostasis testing revenues rose by almost 8 percent year over year, autoimmunity revenues grew by 7 percent, and its new acute care diagnostics business line saw 5 percent organic growth. The firm said its net profit grew 15 percent year over year to €160 million in 2017.


Meridian Bioscience this week declared a regular quarterly cash dividend of $.13 per share, payable on May 17 to shareholders of record as of the end of the business day on May 7.


Novacyt said this week that it had a net loss of €5.4 million ($6.5 million) in 2017, compared to a net loss of €5.7 million in 2016. The firm ended the year with €4.3 million in cash. In January, the company said that 2017 revenues grew 35 percent year over year to €15.0 million.


PerkinElmer this week declared a regular quarterly dividend of $.07 per share of common stock, payable on August 10 to all shareholders of record at the close of business on July 20.


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