NEW YORK – Biovica said this week that it has completed the supplement II process to define the clinical validation for its submission for 510(k) clearance of its DiviTum assay for monitoring and predicting cancer therapy treatment response. The process includes written feedback and meetings with the US Food and Drug Administration, and is the final step before submission for FDA clearance.
The Swedish firm also said that it has reached a deal with an unnamed US oncology group to allow Biovica to analyze samples from a large, high-impact clinical trial of metastatic breast cancer. It will use the results as part of its 510(k) submission. With the new trial, the company has extended the planned submission to the end of 2019 to mid-2020, it said.
In a document filed with the US Securities and Exchange Commission this week, Invitae reported that its recent acquisition, Singular Bio, had a net loss of $1.8 million in 2018 compared to a net loss of $3.3 million in 2017, Invitae said.
Invitae acquired Singular Bio earlier this year. The deal closed in late June, and an unaudited pro forma balance sheet was not reflected in its 10-Q filed with the SEC earlier this month.
In an amended 8K, Invitae said that Singular Bio posted $1.2 million in research and development expenses for 2018 compared to $2.2 million in 2017. The firm had $816,642 in general and administrative expenses last year versus $631,243 in 2017. It ended 2018 with $160,702 in cash and cash equivalents.
Additionally, for the three months ended March 31, Singular Bio's R&D expenses were $476,494 compared to $399,488 from the year ago period. The company's general and administrative expenses nearly doubled during that time to $324,882. Singular Bio reported a net profit of $462,207 at the end of March 31, 2019 compared to a net loss of $636,143 at the end of March 31, 2018. The company ended the quarter with $5.7 million in cash and cash equivalents compared to $160,702 during the same period in 2018.
Agilent Technologies announced this week that it has completed its $1.17 billion acquisition of privately held life science instrumentation manufacturer BioTek Instruments. Agilent said the acquisition will expand its presence in the cell analysis, immuno-oncology, and immunotherapy markets.
The company said it expects BioTek to contribute approximately $20 million to $25 million to its revenues in the fiscal fourth quarter, with no material impact on fourth quarter earnings per share.
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