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In Brief This Week: Bruker, T2 Biosystems, Philips, and More

NEW YORK (360Dx) – Bruker disclosed in its annual 10-K filing with the US Securities and Exchange Commission that it has received a subpoena from the agency's Division of Enforcement seeking information related to an employee terminated as part of a restructuring. The subpoena also seeks information about matters involving the company's policies and accounting practices related to revenue recognition and restructuring activities, as well as related financial reporting, disclosure, and compliance matters, since Jan. 1, 2013. The SEC is seeking information concerning the firm's previously identified material weakness in internal controls over the accounting for income taxes, related financial reporting matters, and certain payments for non-employee travel expenses. Bruker said that it is producing documents in response to the subpoena and intends to continue to cooperate fully with the investigation.

T2 Biosystems reported a fourth quarter 2017 net loss of $18.2 million, or $.51 per share, compared to a net loss of $14.6 million, or $.48 per share, a year ago. It missed the consensus Wall Street estimate of a loss per share of $.43.

The company announced revenues earlier this month but didn't disclose its net loss or loss per share for Q4 or full-year 2017. It reported those numbers in a 10-K document filed with the US Securities and Exchange Commission this week.

For full year 2017, the company posted a net loss of $62.45 million, or $1.94 per share, compared to a net loss of $54.89 million, or $2.11 per share, a year ago. It missed the consensus Wall Street estimate of a loss per share of $1.86.

T2 ended the year with $41.8 million in cash and cash equivalents.

Massachusetts General Hospital and Brigham and Women’s Hospital said this week that they will establish digital pathology centers as part of a deal with Royal Philips. The two hospitals — part of the Partners HealthCare network — will implement the Philips IntelliSite Pathology Solution to enable research and to support clinical diagnosis.

The Philips platform received US Food and Drug Administration clearance in April 2017, making it the first whole-slide imaging system cleared by the agency for reviewing and interpreting digital surgical pathology slides prepared from biopsied tissue.

The collaborators will define and structure each digital pathology center around themes such as user interface design, analytics, education, and the economics of digital pathology. They will deploy specific resources toward projects in these areas with collaboration between members of the Partners Healthcare network and Philips engineers and scientists.

Philips said that MGH and BWH aim to use digital pathology infrastructures to enable research, education, and collaboration and help shape and inform the deployment of digital pathology across the country by establishing best practices and protocols.  

Separately, Philips and the PAMM Foundation announced plans to transform PAMM’s tissue analysis operations to fully digital diagnostics. PAMM, the largest pathology laboratory in the South-East Brabant region of the Netherlands, will also collaborate on the development of smart image-analysis software to identify and quantify cancer cells in tissue samples. PAMM plans to use the Philips IntelliSite Pathology Solution Ultra Fast Scanner to digitalize the 400,000 tissue samples it processes annually, the partners said.

Meridian Bioscience announced this week it is changing its organizational structure to reorganize into two business units — diagnostics and life sciences. The two business units will now have a consolidated sales and marketing team supporting the entire product portfolio. The diagnostics unit will consist of the firm’s Illumigene molecular brand; core diagnostics brands Premier, Merifluor, and Para-Pak; point-of-care brands ImmunoCard, Tru, and Magellan LeadCare; and an immunoassay brand in development called Curian. The life sciences unit will consist of its MLS immunological reagents and Bioline molecular reagents. The new model will also leverage relationships across each of the business units to drive increased efficiency and cost savings, Jack Kenny, the firm’s CEO, said in a statement.

Agilent Technologies this week declared a quarterly dividend of $.15 per share of common stock, to be paid on April 25 to all shareholders of record as of the close of business on April 3.

The Biotechnology Industry Research Assistance Council and PerkinElmer this week signed a letter of intent to work together for five years to promote India-led biomedical, biotechnology, and public health startups and innovators. PerkinElmer said it will continue to invest in India by supporting government initiatives in technology that helps protect the environment, food safety, and the health of mothers and their newborn babies.

Becton Dickinson announced this week that it has signed a definitive agreement to divest its remaining minority stake in Vyaire Medical to funds managed by Apax Partners. According to the terms of the agreement, BD will receive $435 million in cash for its remaining ownership of Vyaire Medical. The transaction is expected to close by the end of April, subject to customary closing conditions. The company expects to record a gain on the transaction at the time of closing. BD said it intends to use the proceeds in line with its broader capital allocation strategy, and that the divestiture will not have a material impact to its revenue or adjusted earnings for fiscal 2018.

Strata Oncology said this week that Aurora Health Care and the University of Texas Health Sciences at Houston have joined the Strata Precision Oncology Network. The network provides advanced cancer patients routine access to tumor profiling and matches them to a portfolio of biomarker-driven pharma-sponsored clinical trials. Since it was founded in 2016, it has expanded to 10 healthcare systems representing more than 85,000 new cancer patients annually, Strata said. Members have access to the StrataNGS test, an 87-gene assay that sequences both DNA and RNA. 

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.