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In Brief This Week: SQI Diagnostics, VolitionRx, Grifols, and More

NEW YORK (360Dx) – SQI Diagnostics this week said that revenues for its fiscal third quarter rose 25 percent to C$220,000 ($167,200) from C$176,000 in Q3 2017.

For the quarter ended June 30, the firm reported product revenues of $141,000, up 642 percent year over year from $19,000. It reported services revenues of $79,000, down 50 percent from $157,000.

SQI's President and CEO Andrew Morris said in a statement, "With each quarter, our commercial traction grows and our business model advances from vision to reality."

SQI said that for the first time, it accomplished "a major commercial milestone" in its business model "with recurring kit sales to a significant customer whose volume of kit usage is growing."

For Q3, the firm recorded a net loss of C$2 million, or a loss of C$.02 per share, compared to a net loss of C$1.6 million, or a loss of C$.02 per share in the prior-year quarter.

In Q3, the weighted average number of shares outstanding used to calculate net loss was 134,936, and in the prior-year quarter the number was 103,875.

The increase in net loss is a result of increased product commercialization, development, and marketing costs, the firm said.

SQI's R&D expenses in Q3 rose 30 percent to C$1.3 million from C$1 million in Q3 2017, while its SG&A expenses rose 9 percent to C$694,000 from C$634,000.

VolitionRx said this week that it had a net loss of $4.6 million, or $.15 per share, for its second quarter compared to a net loss of $3.5 million, or $.13 per share, a year ago. As of June 30, the company had $11.9 million in cash and cash equivalents.

Last week, VolitionRx said it signed a definitive agreement for a private placement offering to raise $9 million in gross proceeds. The company also secured about $700,000 in funding from the Walloon Regional Government in July.

Grifols said this week that the US Food and Drug Administration has approved the relocation of the company's existing immunodiagnostic manufacturing operations to a new consolidated manufacturing facility in Emeryville, California.

The first submission allows for commercial good manufacturing practices fermentation, purification, and bulk fill operations in the new facility, as well as the production of one recombinant HCV antigen. Additional submissions to the FDA to relocate the production of other licensed recombinant protein products are planned, Grifols said.

The company added that the transition to the new facility is targeted for completion in mid-2019, pending the FDA approval of the licensed antigens. Once the transition is completed, Grifols will have transferred 21 products to the consolidated manufacturing facility.

Macrogen said this week that its two next-generation sequencing clinical labs in South Korea have received College of American Pathologists accreditation. The labs are located in Macrogen's headquarters in Seoul and at the Bundang Precision Medicine Center. The company said that it now has three global NGS clinical labs with international accreditation, including Macrogen USA, which received CAP accreditation in October 2017.

The CAP accreditation qualifies Macrogen to provide genetic testing services that conform to the global standard across its clinical diagnostics business. The services include NIPT, cancer panel, BRCA1/2 panel, hereditary cancer panel, and whole-exome sequencing.

Interpace Diagnostics said this week that it has acquired a majority of the equipment from the Philadelphia laboratory of Rosetta Genomics through a bankruptcy auction. Interpace acquired 64 select lots of laboratory assets, including freezers, refrigerators, PCR machines, and advanced slide scanning equipment, as well as laboratory supplies and specialty furniture. The equipment will be used in Interpace's labs in Pittsburgh and New Haven, Connecticut. Financial details of the sale were not disclosed. 

Interpace also said it has hired several former Rosetta employees since the firm filed for Chapter 7 bankruptcy in June, and that select former Rosetta customers have transitioned their accounts to Interpace’s thyroid assays.

NanoString Technologies said this week that the underwriters of its previously announced public offering exercised their option to purchase an additional 600,000 shares of its common stock. Net proceeds from the offering were around $53.9 million. The company intends to use the funds for the development and launch of its Digital Spatial Profiling platform, the continued commercialization of its portfolio of nCounter-based products, and for general corporate purposes and working capital.

JP Morgan and UBS Investment Bank acted as joint book-running managers for the offering. Baird acted as lead manager for the offering.

Exact Sciences said that it has broken ground on a new 138,000 square-foot building, named Innovation One, which will serve as its corporate headquarters in Madison, Wisconsin. The company expects the building to be complete in 2020.

Bruker said this week that its board approved a quarterly cash dividend of $.04 per share, payable on Sept. 21 to stockholders of record as of Sept. 4.

Quest Diagnostics’ board of directors declared a quarterly cash dividend of $.50 per share, payable on Oct. 22 to shareholders of record on Oct. 5.

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.