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SQI Diagnostics to Submit Array-Based Assays to FDA for 2008 Launch

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This story has been updated from a previous version, which incorrectly stated that SQI had signed an agreement with Bio-Rad. This was an error caused by an editing oversight.  
 
SQI Diagnostics, a Toronto-based automated medical systems developer, plans to submit array-based assays for rheumatoid arthritis and thrombosis to the US Food and Drug Administration in 2008 for a possible market launch that year.
 
The company recently concluded an internal performance study of one of the assays, which showed positive results. As a result of the evaluation, the company is confident that its products will perform well in the clinical testing market, Andrew Morris, SQI’s chief financial officer, wrote to BioArray News in an e-mail.
 
According to Morris, SQI’s first assays will test for protein biomarkers or antibodies as opposed to DNA markers, and the company intends to find a market that will use its automated, multiplex technology to replace more time-consuming enzyme-linked immunosorbent assays.
 
“In general the underlying chemistry we are currently focused on is ELISA-based using known antibody pairs,” Morris wrote. “If the capture and reporter are known [then] the test can be put on this platform, though we are not precluded from other methods [that use] DNA-based chemistries.”
 
SQI Diagnostics’ platform consists of the SQiDworks automated workstation and QuantiSpot, a 96-well microarray consumable. Morris wrote that workstation users are typically able to process multiplexed assays to quantify serum concentrations of up to 12 individual biomarkers or qualitatively detect up to 24 biomarkers per patient.
 
SQI plans to seek 510(k) approval for its QuantiSpot Rheumatoid Panel. The test combines ELISAs previously available for rheumatoid factors IgG, IgA, and IgM with anti-cyclic citrullinated peptide antibodies into one automated assay that it claims can yield “a conclusive diagnostic result.”
 
“While the rheumatoid factor is more common in rheumatoid arthritis patients, many patients with a positive test do not have rheumatoid arthritis,” Morris wrote. “Furthermore, the presence of the rheumatoid factor has less prognostic significance than the CCP [marker].”
 
The combination of all four markers, along with the smaller blood samples needed for an array-based assay, could create a way for SQI to enter the clinical testing market, Morris added.
 
“The benefits … are providing a precise, quantified result,” he wrote. Clinicians will receive a quantified result of antibody concentrations in order to make decisions on the likely presence of rheumatoid arthritis, differentiate between other possible reasons for symptoms, assess the progress of the disease, and determine relative improvements in therapies applied over time, wrote Morris.     
 

“Our development and commercialization efforts focus on currently in-use tests where there are multiple analytes interrogated for use in diagnosis of disease conditions.”

SQI last week announced results of an internal validation study of the QuantiSpot Rheumatoid Panel, stating that the test “generates equivalent results to current technologies” like ELISAs, while requiring less time and labor. The company is now shipping the system to undisclosed external validation sites where it will collect data that will be useful in its FDA submission package next year.
 
Rather than competing against other diagnostics shops with array-based platforms, such as GenTel Biosciences or Osmetech Molecular Diagnostics, SQI will most likely market its QuantiSpot Rheumatoid Panel as an alternative to entrenched ELISA-based tests, such as Axis-Shield’s DIASTAT Anti-CCP test, which is sold in Europe and the US.
 
According to Morris, SQI sees the most opportunity for its platform and tests in replacing older technologies that test the same markers. “Our development and commercialization efforts focus on currently in-use tests where there are multiple analytes interrogated for use in diagnosis of disease conditions,” he wrote. “These tests derive the most benefit from the multiplexing and automation benefits.” 
 
Clinical Market Yes, Drug Development No
 
As SQI prepares its QuantiSpot Rheumatoid Panel and SQiDworks platform for 510(k) submission, it is also transitioning from a platform and test-development company to a viable, commercial entity. For SQI this means preparing its Good Manufacturing Processes-compliant facility in Toronto for full-scale manufacturing as well as creating a sales and support organization capable of supporting the launch of the product.
 
According to Morris, as it moves into the marketplace SQI will also retain its focus on the clinical market, rather than trying to serve multiple markets, such as clinical testing, academic research, and pharmaceutical drug discovery.
 
He said the company is “primarily focused” on in vitro diagnostics for autoimmune disease, infectious disease, and allergen testing. “While the platform would offer advantages to users in the research [or] drug-development space, we are not focusing on those markets at this time,” Morris added.
 
According to SQI’s website, the US market for autoimmune tests is $1.4 billion and is growing 6 percent annually; the infectious disease market is estimated to be $3.6 billion and is growing 12 percent each year; and the allergen testing market is estimated to be $450 million and is growing around 6 percent annually.
 
SQI envisions itself providing dozens of tests on the SQiDworks platform, not only for rheumatoid arthritis but for other autoimmune disorders like Crohn’s disease and lupus; vascular diseases; hepatitis; and sexually transmitted diseases.
 
The company has not announced further details regarding the launch of its thrombosis panel, which will offer a multiplex test for beta 2 glycoprotein and cardiolipin markers each for IgG, IgA and IgM, respectively.
 
According to Morris, the firm believes the combination of its multiplex test and its automated platform will secure its entry to the market. “The combination of multiplexing and automation is expected to drive significant cost and process advantages to our potential customers in the reference and hospital laboratories,” he wrote. “The net result is the ability to produce diagnostic-grade outputs with significant savings in labor and reagents.”

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