Cellex–rapid and sensitive flu test

Project Manager:  X James Li;  Principal InvestigatorRichard  Zhao, UMB
Location:  Rockville, Maryland – Montgomery County;  Project Start Date:  8/1/2010

Business Description
Cellex develops technologies and products for diagnostic tests suitable for point-of-care use.

Cellex sought a clinical study of the company’s rapid, point-of-care method for diagnosing influenza and flu virus drug resistance.

A clinical study was conducted for Cellex’s QFLU, a test designed to simultaneously diagnose influenza and detect flu virus drug resistance in point-of-care settings. The clinical study involved three clinics and enrolled several hundred voluntary patients. Two nasophyrangeal swabs were collected from each participant. One of the swabs was used for culture-based detection, while the other was used for QFLU test-based detection. The cell culture method is a gold standard for setting a cutoff value and for determining the preliminary sensitivity and specificity for the QFlu test. Mutations as identified by sequencing were used as a gold standard for drug resistance.

The MIPS grant funding enabled Cellex to gather clinical data, which helped the company get a $2 million NIH grant, which in turn permitted them to perform a large clinical study enrolling more than 500 patients. The data from the MIPS and NIH-funded studies was submitted to the FDA in September 2012, in an application for approval for Cellex’s first product, the QFlu Combo Test, which can be used to simultaneously diagnose influenza and detect resistance to Tamiflu. This is a first-of-its-kind product that has great commercial potential and significant public health implications. Cellex is confident it can be approved by the FDA in 6-9 months.

Cellex will also apply for FDA approval for the second product, the QFlu Diagnostic Test, which is intended to be used for influenza diagnosis. Cellex anticipates potential approval by as early as late December 2012.

MIPS-Related Quote
“The MIPS grants have played an important role in bringing the QFlu project to a successful conclusion.”
–Dr. X. James Li, Chief Scientific Officer, Cellex

Leading up to (and beyond) the Maryland Industrial Partnerships (MIPS) 25th Anniversary Gala, each weekday we will briefly profile one (or more) of the 500+ companies that have utilized MIPS funding to bring innovations to market and create jobs in Maryland.

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