Clinical Development Projects

Cross-discipline collaborations to develop various aspects of label-free sensing for rapid clinical testing

The emergence of personalized and stratified medicine is changing the landscape of clinical testing, driving the need for new point-of-care devices. Innovative diagnostic devices are essential for realizing these emerging trends.

Label-free affinity biosensors are widely considered to be the technological solution to address these challenges. Together with academic and clinical research institutions, we strive to accelerate the commercialization of high-potential discoveries into the global market.

Current Clinical Development Cases

Inline Sample Filtration for Rapid Testing

Blood is complex. Time consuming sample preparation is often required. We are currently developing an inline sample filtration process for continuous monitoring of small therapeutic agents directly in serum. 

Cancer Therapeutic Monitoring ​

Drugs with a narrow therapeutic window require frequent monitoring to ensure treatment safety and efficacy. We are developing a test to monitor methotrexate, an anti-cancer drug, within minutes in serum.

Protein Deficiency in Blood for Transfusion ​

In the Canadian Blood Services donor screening program, anti-IgA antibodies were identified in 41% of severely deficient donors. We are collaborating with a blood bank to develop a rapid test for IgA and related proteins in samples.

Future Direction

The Case of Cancer Immunotherapy in the US

< 1 %
Current success rate

of the total cancer patient population respond positively to treatments. When tested for eligibility, this rate increases to 1:3 patients.

$ 1 k+
Annual cost

of immunotherapy can be well over $100,000 annually despite the low success rate.

1 +
Biologics in pipeline

As the drug landscape shifts, many challenges such as therapeutic drug monitoring (TDM) remain mostly unaddressed.

Companion devices for biologics safety and efficacy monitoring

POC Device for Therapeutic Drug Monitoring

The Emerging Trend

We are experiencing a rise in new therapy such as biologics that are addressing unmet medical needs. These therapies are more precise and specific thus paving the way towards personalized medicine.

The Opportunity

There is an exploding need for testing patients prior and during more personalized therapy. Several tests are often required to establish patient eligibility to biologic treatments. Additionally, constant monitoring during the treatment is necessary to ensure the safety and efficacy of the therapy.

For more information please email us

info@affiniteinstruments.com