• About Cellex

  • We are passionate about saving lives with pioneering proven diagnostics

Proven Expertise

Founded in 2002, Cellex Incorporated is a biotech company that develops technologies, instruments and assays for testing of human diseases and conditions, particularly for point-of-care (POC) professional healthcare settings. Based in Morrisville, NC, the company maintains both a GMP manufacturing site in Suzhou, China (ISO 13485 certified, FDA QSR) and an exclusive manufacturing partner in Zhengzhou (Hunan Province).

Pioneering Technologies

Founder James Li and the Cellex team had already created a lineage of more than 50 pioneering diagnostic test successes on multiple platforms (drug resistance, UTI, TB, MI and others) when the COVID-19 outbreak began. They realized that their technologies could help save lives if they moved quickly to bring multiple COVID-19 tests to commercial readiness.

Saving and improving lives around the globe

Under Dr. Li’s guidance, the Cellex team continues to advance diagnostics for global healthcare for the following conditions :

COVID-19 Tests

  • Antibody: first company to receive FDA EUA on April 1, 2020.
  • Antigen: First to submit a home-use EUA application to FDA, POC also submitted. 94.6% sensitivity.
  • Enzyme activity: mass screening and disease progression assay; FDA EUA application early 2021.
  • COVID-19/flu combo: in development. FDA EUA submission early 2021.
  • Neutralizing antibody: high throughput assay. FDA EUA submission early 2021.

Other Diagnostic Tests for International Markets

  • Diabetes: glycated albumin, CV<3%.
  • Influenza: enzyme test, not affected by mutations.
  • Bacterial drug resistance rapid test.
  • Bacterial vaginitis rapid test.
  • UTI rapid test.
  • TB rapid test.
  • Chemotherapy monitoring.
  • Myocardial Infarction adjunct testing.
  • 46 rapid tests: infectious and tropical diseases, GI, parasites, hormone, etc.
  • Please email info@cellex.com for more information.

Patents and Trademarks

Cellex’s products are covered by various patents. The assays such as the qFLU Combo Test, which use the homogeneous biochemiluminescence assay (HBA) technology, are covered by the U.S. patents 7,893,272 and 8,558,004. Lateral flow-based products for COVID-19 are covered by U.S. patent D939105, UK patent registrations 6121578 and 6123712, and Brazil patent 3020210008858.

CELLEX®, ®, QFLU®, HELIOS®, QSARS™, QCOV™ and WE ARE IN THE BUSINESS OF SAVING LIVES™ are trademarks owned by CELLEX, INC.. In certain cases, these trademarks are registered before applicable authorities in the United States and elsewhere in the world. CELLEX, INC. trademark registrations include, without limitation, U.S. Reg. Nos. 3610279, 3220484, 3606661 and 4723444. All rights are expressly reserved.