NEW YORK (360Dx) – SQI Diagnostics this week said that revenues for its fiscal fourth quarter ended Sept. 30 dropped 82 percent to C$126,000 ($98,280) from C$709,000 in Q4 2016.
SQI noted that its revenues for the first nine months of fiscal 2017 were greater than in 2016. However, in the fourth quarter, it transitioned customers out of development and into customer site validations, which caused a decrease in quarter-over-quarter revenues.
SQI's President and CEO Andrew Morris said in a statement that the firm has "built a solid pipeline with new customers who are well-advanced to provide ongoing revenues in the coming fiscal year."
For Q4, the firm recorded a net loss of C$1.5 million, or C$.01 per share, compared to a net loss of C$1.2 million, or C$.02 per share in the prior-year quarter.
In Q4, its R&D expenses dropped 2 percent to C$757,000 from C$775,000 in Q4 2016, while its SG&A expenses rose 14 percent to C$641,000 from C$560,000.
For fiscal 2017, SQI's revenues dropped 31 percent to C$968,000 from C$1.4 million in fiscal 2016. The firm's net loss for the year was C$5.9 million, or C$.06 per share, compared to C$5.0 million, or C$.07 per share, for fiscal 2016.
In fiscal-year 2017, its R&D costs rose 7 percent to C$3 million compared to C$2.8 million in fiscal 2016, while its SG&A expenses rose 9 percent to C$2.4 million from C$2.2 million.
SQI said that during fiscal-year 2017 it raised about C$3.7 million in an oversubscribed private placement. Subsequent to year-end, the firm announced a private placement of up to 30 million units of the firm at a price of $.15 per unit for gross proceeds of up to C$4.5 million.
ArcherDX announced that it has earned ISO 13485:2003 and EN ISO 13485:2012 certification from the British Standards Institution. This ISO certification indicates that the company's quality management system maintains standards specific to medical devices, including in vitro diagnostic assays. Specifically, product samples are regularly subjected to rigorous, independent testing to ensure that they comply with stringent standards for safety, product performance, and reliability.
CareDx reported this week that it has agreed to immediately repay certain obligations related to its acquisition of Allenex AB, which eliminates the requirement to issue 1.8 million new shares.
Of the total $4.7 million deferred purchase consideration owed to the former majority shareholders of Allenex AB, approximately $2.0 million was due by Dec. 31, and was to be paid in 1.8 million shares of common stock, pending stockholder approval, CareDx said. The remaining balance of $2.7 million was due to be paid in cash on March 31, 2019. Under the amended agreements, CareDx will pay the total deferred purchase consideration of $4.7 million, plus accrued interest, immediately.
Singapore-based life science and molecular diagnostic company Mirxes this week said its manufacturing facility has received ISO certification, and it has received CE-IVD marking for its gastric cancer kit. The company also launched a new life science reagent called BlitzAmp, and said it plans to expand in 2018 and 2019 with commercial partners across Asia, Europe, and the Middle East.
Merit Medical Systems this week agreed to purchase certain assets from Becton Dickinson in connection with BD's proposed acquisition of CR Bard.
Merit's proposed asset acquisition is subject to the closing of BD's proposed acquisition of Bard as well as other usual and customary closing conditions.
The assets to be acquired are soft tissue core needle biopsy products currently sold by BD under the trade names of Achieve Programmable Automatic Biopsy System, Temno Biopsy System, and Tru-Cut Biopsy Needles.
Merit said it also plans to acquire the Aspira Pleural Effusion Drainage Kits and the Aspira Peritoneal Drainage System currently marketed by Bard.
The purchase price for these product lines and related assets is $100 million, subject to adjustment for fluctuations in the value of transferred inventory. Merit intends to finance the acquisition at closing through borrowings which are currently available under its revolving credit facility.
Personalis has launched an early-access program for its cell-free DNA technology, which enables the detection of neoantigens across an exome from a single blood sample. The technology may enable monitoring of previously detected neoantigens and identification of new ones at multiple time points pre- and post-cancer treatment, the company said. The research-use-only early-access program will be offered exclusively to the company's immuno-oncology partners.
Macrogen said this week that its clinical lab has been accredited by the College of American Pathologists, based on results of a recent on-site inspection.
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.