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In Brief This Week: Thermo Fisher, BioReference Laboratories, Hologic, Invitae, Danaher, and More

NEW YORK – Thermo Fisher Scientific said this week that it has completed the acquisition of point-of-care molecular diagnostics company Mesa Biotech, first announced last month. The company will become part of Thermo Fisher's Life Sciences Solutions business segment and is expected to add approximately $200 million to its revenues in 2021.

Mesa Biotech offers the Accula system, a point-of-care PCR platform for infectious disease diagnostics that provides results in 30 minutes. It currently includes tests for COVID-19, flu, respiratory syncytial virus (RSV), and Strep A.

"The Accula system complements our existing offerings and immediately provides our clinical customers with more options and flexibility for COVID-19 testing," said Mark Stevenson, executive VP and chief operating officer of Thermo Fisher, in a statement. "And, as the point-of-care diagnostic market expands globally, we're well-positioned to deliver a broader menu of tests to meet increasing demand."

Separately, Thermo Fisher also said this week that its board of directors has authorized an 18 percent increase to its quarterly cash dividend, to $.26 per common share from $.22 per common share. The dividend is payable on April 16 to shareholders of record on March 16.

In its Form 10-K filed with the US Securities and Exchange Commission last week, Opko disclosed that its subsidiary BioReference Laboratories had received notification on Feb. 3 from the US Department of Labor that it would conduct a wage and hour investigation at BioReference subsidiary GenPath for 2019 and 2020. The Labor Department was seeking records related to gross sales, employee roster information, comprehensive payroll and time-log records, and 1099 forms and contract records for independent contractors and subcontractors.

The firm also disclosed in the filing that BioReference received a subpoena from the New Jersey Department of Labor requesting similar information for the same time period. The NJ DOL also asked for info related to unemployment and disability taxes, workers’ compensation, earned sick leave, and other financial information. Opko said it didn’t know if the two requests were related and that BioReference is currently gathering the information.

Hologic this week completed its previously announced acquisition of molecular oncology test company Biotheranostics for approximately $230 million. Biotheranostics develops and markets two molecular diagnostic tests for breast and metastatic cancers – Breast Cancer Index (BCI) and CancerType ID (CTID). Hologic noted that the National Comprehensive Cancer Network revised its clinical practice guidelines last month to include BCI as a gene expression assay that predicts the benefits from extended endocrine therapy for patients with early-stage hormone-receptor-positive breast cancer.

Invitae said this week it has added tools from digital health artificial intelligence firm Medneon to its clinical workflow, to make it easier for clinicians to determine which patients need genetic testing to assess their cancer risk and how to use the results to guide treatment. Medneon's Predictive Risk Assessment synthesizes current guidelines, real-world evidence, and patients’ personal and family history of cancer to estimate their lifetime and short-term risk. Based on this, doctors can decide if patients should receive genetic testing and imaging. The platform can also help determine if patients meet insurers' coverage criteria for testing. After results are returned, Medneon's Personalized Genetic Insights draws on information from the published literature and the AI knowledge base ASK2ME and issues customized reports to help doctors treat patients.

Sonora Quest Laboratories and Genalyte said this week that they have entered a strategic partnership with Cigna Medicare Arizona to use analytics to reduce costs and improve clinical outcomes for the payor’s Medicare Advantage customers. Genalyte uses analytics to stratify patients by health condition risk and clinical interventional opportunities and pinpoints patients who should be targeted with diagnostic and therapeutic interventions.

Danaher announced this week that its board of directors has approved a quarterly dividend of $.21 per common share, payable on April 30 to shareholders of record on March 26. The board also approved a quarterly cash dividend of $11.86 per share of its 4.75 percent Series A Mandatory Convertible Preferred Stock, and a quarterly cash dividend of $12.50 per share of its 5 percent Series B Mandatory Convertible Preferred Stock, both payable on April 15 to shareholders of record on March 31.

Yourgene said this week that it has partnered with Newcastle Premier Health, a provider of medical services, to offer COVID-19 PCR testing services to Leeds Bradford Airport. Testing will be made available to departing and arriving passengers, as well as the local community, and samples will be processed at Yourgene's Manchester laboratory using the company's Clarigene SARS-CoV-2 assay.

The Fourth Circuit Court of Appeals this week upheld a $114 million verdict in a whistleblower lawsuit against a blood laboratory CEO and two sales consultants. LaTonya Mallory, the former CEO of Health Diagnostic Laboratory, and consultants Robert Johnson and Floyd Dent had appealed the 2018 verdict that found them guilty of violating the False Claims Act and the Anti-Kickback Statute. They were accused of paying processing fees to clinicians in exchange for patient referrals for blood tests. The laboratory then billed federal healthcare programs for medically unnecessary testing. Mallory was also accused of paying Johnson and Dent tens of millions of dollars in sales commissions to induce physicians to order expensive blood tests of "dubious medical value or necessity," law firm Phillips and Cohen said in a statement.

Interpace Biosciences said this week that it has satisfied the requirements for trading its common stock on the OTCQX Best Market. The firm will begin trading on OTCQX at the open of the market on Feb. 25 under the symbol IDXG. Interpace had received a delisting notice from the Nasdaq earlier this month.

The firm also noted that Blue Cross Blue Shield of Illinois has agreed to provide both coverage and in-network status for its molecular combination thyroid tests, ThyGeNext and ThyraMir.

Bio-Techne this week announced that its sites in Abingdon, Langley, Rennes, and Wiesbaden received ISO 14001:2015 certification for environmental management systems. The Bio-Techne facilities provide sales, marketing, purchasing, order processing, warehousing, distribution, and customer services for the Europe, Middle East, and Africa region.

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.