Precision and method comparison
Trace® is evaluated in data studies on various parameters - below typical data output related to assays Lipids and HbA1c are shown.
Lipids - Precision
Within-run, between day and total precision were determined for Trace® Lipids control C1 and C2 for 5 days. The samples were analyzed in duplicated twice a day. a) The LDL was calculated according to the Friedewal equation LDL = ( TC - HDL - TG/2.17 ) *
* Trace® does not calculate the LDL concentration if the Triglyceride concentration exceeds 4.51 mmoI/L
HbA1c - Precision
Within-run, between day and total precision were determined for trace® HbA1c control C1 and C2 and two user samples assayed for 5 days. The samples were analyzed in dupilicate twice a day.
Lipids - Method Comparison
trace® Lipids was compared to three of DiaSys (Holzheim, Germany) single Lipids kits (Cholesterol FS, HDL immune FS and Triglycerides FS). Analysis on the Hitachi 912 system.
HbA1c - Method Comparison
Trace® HbA1c was compared to the Tosoh G8 HPLC (ion-Exchange method) analyzer.
Global Sales Road Map
EUROPE CE MARK: May 2017
Trace® becomes available through company web site and local distribution sales channels throughout EU
During 2015 & 2016 prior to CE-Mark – A range of user feed back studies have been run on a beta version of the Trace® platform:
- Remote monitoring trials via local (Denmark) telemedicine projects in collaboration with medical institutions
- Tests in out-patient clinics for patient empowerment
- Home-use trials in collaboration with academic institution or via reward based crowd-funding platform
Country specific regulatory approvals will be sought with partners.
Trace® becomes available for individual countries as approvals are obtained
Provided appropriate partners are identified, user feedback studies are expected to be initiated during 2017-18
- Pharmacy-on-site-testing together with pharmacy chains
- Remote monitoring trials together with local medical institutions
Trace® 510(k) approvals will be targeted in 2018. Intended use will depend on commercial partnering activities.
During 2017 - prior to 510(k) approval - we are planning to conduct user feedback studies in the form of:
- Investigational trials with specific healthcare program providers
- Clinical trials to support approval process and claims
- CLIA waiver user studies in support of waived labs, home use and remote monitoring