Trace® Data

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.

Trace® Timelines

Global Sales Road Map

Europe

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

Asia

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

USA

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