Point-of-Care MDx

Historically, reliable test-and-treat options have been very limited for physicians, because:

1. Rapid immunoassay tests developed for point-of-care use have poor sensitivity (and must be confirmed with lab-based molecular tests), and
2. Nucleic acid-based methods have been too technically complex, too expensive and too slow to be implemented in the physician office.

Key clinical drivers for physician office testing are:

  • Better clinical outcomes for some conditions by providing immediate results
  • Testing of patients who may otherwise not be tested
  • Allowing selection of treatment based on molecular-level information
  • Reduction in loss to follow-up
  • Tests can be performed without expensive lab infrastructure and personnel.

In an effort to reduce the 2-10 day turn-around time of lab-based tests, many molecular diagnostics manufacturers have started developing automated platforms. Unfortunately, almost all are systems that incrementally automate existing lab technologies (e.g. PCR tests). However, turnaround times less than one hour, a critical feature for point-of-care testing, have not yet been achieved.

Xagenic has developed a nucleic acid testing platform based on a novel technology that has the sensitivity and specificity of PCR-based assays and a time-to-result of 20 minutes. With Xagenic's new testing platform, molecular testing will be performed in the physician office, addressing a critical unmet need in the healthcare system.

“Xagenic's technology is comparable with PCR's performance in terms of specificity and sensitivity, and outperforms it in speed, simplicity, size, ease-of-use, cost, and compatibility within an office setting.”
CHRISTI BIRD, Senior Industry Analyst, Frost & Sullivan