SQI Diagnostics continues discussions with the FDA to market it's SQiDworks Diagnostics Platform in the US

Aug 24 2009

SQI Diagnostics Inc. (TSX-V: SQD), a medical systems automation company focused on evolving laboratory-based biomarker testing, today announced its financial and operational results for the third quarter ended June 30, 2009.

"We continued our discussions with the U.S. Food and Drug Administration during the quarter on our application to market SQI's automated SQiDworks(TM) Diagnostics Platform and its QuantiSpot(TM) Rheumatoid Arthritis (RA) Assay in the United States," said Andrew Morris, CFO of SQI Diagnostics. "We expect to have a decision from the FDA shortly. A favourable decision would allow us to market our technology to U.S.-based clinical laboratories focused on keeping pace with the growing demand for biomarker testing. We have already made progress with potential customers in Canada where our platform and RA assay are currently approved for sale."

Outlook

SQI anticipates executing on a number of upcoming milestones in the coming quarters including:

- Attaining a response from the FDA regarding the Company's application
to sell its SQiDworks Platform and QuantiSpot RA test kit in the
United States;

- Developing a customer base of clinical laboratories in Canada and the
U.S.;

- Building out its franchise of QuantiSpot autoimmune test panels
including test panels for Irritable Bowel Disease (Crohn's disease,
ulcerative colitis), Celiac disease, and Thyroid Disease;

- Adding CCP IgA as a fifth biomarker to the current Health Canada-
approved 4-plex RA; CCP IgA has clinical utility as an early RA
indicator; and,

- Commercializing a novel anti-TNF Research-Use-Only product to assist
clinicians in the treatment of Inflammatory Bowel Diseases and RA
diseases.
Financial Results

For the quarter ending June 30, 2009, the Company recorded a net loss of $1,354,277 ($0.05 per share) compared to a net loss of $1,323,804 ($0.06 per share) for the quarter ended June 30, 2008. The net losses for the period ending June 30, 2009 were materially the same as for the quarter ending June 30, 2008.

Research and Development expenses were $825,129 in the quarter ending June 30, 2009 compared to $828,032 during the same quarter last year.

Corporate expenses, which include administrative salaries and related expenses; general and administrative expenses; advertising and promotion expenses; travel expenses; interest expenses and professional and consulting fees totaled $210,239 for the quarter ended June 30, 2009 compared to $130,639 for the quarter ended June 30, 2008. The major contributors to the increase between the periods were costs related to travel for supplier quality validation, salary-related compensation increases and marketing costs.

At June 30, 2009, current assets were $4,402,113 compared to $4,362,320 at September 30, 2008. Working capital as at June 30, 2009 was $4,022,693 compared to $3,244,418 at September 30, 2009.

Management believes that the cash on hand at June 30, 2009 will be sufficient to fund Company operations to the middle of 2010. The successful commercial launch and generation of revenue in the 2010 fiscal year would extend that period.

Source: SQI DIAGNOSTICS INC.