NEW YORK (360Dx) – BrainBox Solutions said this week the US Food and Drug Administration has granted breakthrough device designation to the company's BrainBox TBI test for aiding in the diagnosis and prognosis of mild traumatic brain injuries. The multiplex fluorescence immunoassay test comprises the biomarkers glial fibrillary acidic protein, neuron specific enolase, neurogranin, and other measurements. The multimodality, quantitative test combines the biomarkers with computerized neurological assessments and is for use in point-of-care or clinical laboratory settings.
Additionally, Richmond, Virginia-based BrainBox announced the start of its clinical study called HeadSMART (Head injury Serum markers and Multimodalities for Assessing Response to Trauma) to support regulatory filings for marketing approval of the TBI test. The study, which is expected to last 18 to 20 months, includes serial assessments collected from 20 sites in the US, UK, and Australia, and will enroll patients from hospital emergency rooms and urgent care settings. BrainBox was spun off from ImmunArray last fall.
Laboratory Corporation of America said this week that its Covance Drug Development segment has completed its acquisition of Envigo's nonclinical researcher services, while Envigo's Research Models Services business has bought LabCorp's Covance Research Products business. When the deals were announced last month, LabCorp said that it would pay $485 million. It added that the deal is anticipated to add $156 million to LabCorp's revenues on a pro forma basis for 2019.
Meridian Bioscience said this week it has completed its acquisition of GenePOC. The firm announced in April that it would acquire the Quebec City-based molecular diagnostics maker for $50 million, with future milestone-based payments of up to an additional $70 million.
Quidel said this week that it has entered into separate, privately negotiated exchange agreements with certain holders of its 3.25 percent convertible senior notes due 2020. Pursuant to these agreements Quidel will exchange approximately $45.4 million in aggregate principal amount of the 2020 notes for approximately 1.3 million shares of the company’s common stock plus an additional number of newly issued shares of its common stock to be determined based on the volume weighted average price of the stock over the three consecutive trading days commencing on June 5, 2019. The transactions are expected to close on June 17, 2019.
German technology firm Schott said this week it has reached a deal to acquire Australian microfluidics company Minifab for an undisclosed amount. The deal is expected to close in the coming months.
Founded in 2002 Minifab provides customized polymer microfluidics, and has 150 employees and operations in Europe and the US. Schott supplies glass substrates for microarrays and microfluidic components made of glass. The combined firms will create centers of excellence for polymer in Australia and glass in Germany, Schott said, adding customers will benefit from the transaction as it will result in a complementary portfolio of "top quality" polymer and glass solutions for the diagnostics space.
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