MIPS Project Detail:

Cellex, Inc.

A Rapid and Sensitive Flu Test

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Company

Cellex, Inc.

Rockville

Montgomery

County

, Maryland

Founded:

1998

Website:

http://cellex.us

Company Description:

Cellex is a medical device company dedicated to developing innovative technologies that enable assays to be fast, accurate, sensitive, easy-to-use and inexpensive. The company’s current focus includes a homogeneous biochemiluminescent assay (HBA) technology, HBA-based assays and easy-to-use instruments.

MIPS Project

A Rapid and Sensitive Flu Test

Project #

4311

|

MIPS Round

43 |

Starting Date:

Feb 2009

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

Project Scope:
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 grants have played an important role in bringing the QFlu project to a successful conclusion.

X. James Li, Chief Science Officer, Cellex

Results:

This MIPS project enabled Cellex to gather clinical data, which helped the company get a $2 million NIH grant, which in turn permitted the company to perform a large clinical study enrolling more than 500 patients. The data from the MIPS and NIHfunded 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 commercial potential and public health implications.

Other than the qFLU combo Test, the assay was also configured into a diagnostic-use only test, the qFLU Dx Test. The qFLU tests are the only tests that do not detect viral proteins (antigens) or nucleic acids, and are less susceptible to genetic changes of flu viruses. Both the qFLU Combo Test and qFLU Dx Test have now been CE-marked.

Working with BD (Becton, Dickinson and Co.), the qFLU Combo Test was awarded another grant by the Biomedical Advanced Research and Development Authority (BARDA). The award supports the clinical evaluation of the assay for its use in global influenza surveillance. The regional rights of these qFLU assays were licensed to third parties in various regions. The qFLU Dx Test is particularly suited for markets with dense populations such as China, as the assay is rapid, can be performed in large batches, and uses simple instruments.