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In Brief This Week: Danaher, HTG Molecular, Bruker, and More

NEW YORK (360Dx) – A spokesman for Danaher confirmed this week that its Beckman Coulter Life Sciences subsidiary acquired privately held liquid handling firm Labcyte for $308 million. Danaher recently disclosed in its Form 10-Q filed with the US Securities and Exchange Commission that it acquired a company for $308 million during the first quarter of the year, but did not name the company. Beckman Coulter bought Labcyte in January. In its SEC filing, Danaher estimated that Labcyte's aggregate annual sales are $61 million.

HTG Molecular announced this week that it has amended its IVD Test Development and Component Supply Agreement with Illumina  —  previously amended in 2017 — to expand into additional fields for development and commercialization of IVD test kits. As part of the amended agreement, HTG can now submit development plans to Illumina for autoimmune, cardiovascular, and fibrosis disorders and diseases that will use the firm's EdgeSeq platform and Illumina's sequencing technology.

In a filing with the US Securities and Exchange Commission this week, Bruker reported that the SEC's Division of Enforcement has notified the Company that it has concluded an investigation dating back to October 2017, and that it does not intend to recommend an enforcement action by the SEC against the company based on the information received to date.

In October 2017, Bruker received a notice of investigation and subpoena to produce documents from the Enforcement Division in relation to an employee whose employment was terminated as part of a restructuring, certain matters involving the company's policies and accounting practices related to revenue recognition and restructuring activities, as well as certain other financial reporting, disclosure, and compliance matters. 

Bruker also said that its own audit committee has concluded its previously reported internal investigation into the practices of certain business partners in China and into the conduct of former employees of the Bruker optics division in China.

Myriad Genetics announced this week that Kroger Prescription Plans will provide the company's GeneSight pharmacogenetic test as a benefit option for Kroger Prescription Plan employer group clients. According to Myriad, pharmacists at more than 2,300 Kroger stores will provide counselling about the test to group members eligible to receive testing, and will facilitate access to testing with their prescribing doctors. The companies inked a similar arrangement last year for Myriad’s Vectra DA rheumatoid arthritis test. 

Becton Dickinson announced this week that its board has declared a quarterly dividend of $.77 per common share, payable on June 28 to shareholders of record on June 7. This indicates an annual dividend rate of $3.08 per share. In addition, the board declared a quarterly dividend of $15.31 per share on the 6.125% mandatory convertible preferred stock, Series A, payable on Aug. 1 to holders of record on July 15. This represents $.77 per depositary share.

RenalytixAI announced this week that the US Food and Drug Administration has granted Breakthrough Device designation for its KidneyIntelX diagnostic platform. The assay uses machine learning algorithms to assess the combination of blood-based markers and electronic health records to identify progressive kidney disease.

Caris Life Sciences announced this week that the US Food and Drug Administration has granted Breakthrough Device designation for the firm's MI Transcriptome companion diagnostic assay. Caris plans to submit the assay for pre-market approval in Q4 2019.

Oxford BioDynamics said this week that it has joined the REFINE-ALS study, which is designed to identify and measure specific biomarkers for amyotrophic lateral sclerosis (ALS). The study is being sponsored by Mitsubishi Tanabe Pharma America (MTPA) and led by Massachusetts General Hospital Neurological Clinical Research Institute. Oxford BioDynamics will use its EpiSwitchplatform to evaluate epigenetic and protein biomarkers in order to offer insights on disease progression and treatment effect.

Biomarkers including oxidative stress, inflammation, neuronal injury or death, and muscle injury, as well as clinical assessments, will be obtained from up to 300 patients in the US prior to initiating treatment with edaravone, at the start of treatment, and at pre-specified time points for 24 weeks. Oxford BioDynamics will evaluate biomarker panels utilizing EpiSwitch to assess epigenetic biomarkers known as chromosome conformation signatures.

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.