VIROTRACK PORTFOLIO & ROADMAP2020

DIAGNOSTICS OF TRUE VALUE

ViroTrack portfolio & Roadmap

At risk of life-threatening diseases

About BluSense

Every single day, thousands of physicians postpone the prescription of medical treatment for their patients because they lack immediate access to accurate blood test results at the point-of-care.

To date, mosquito-borne diseases have been diagnosed by taking a blood sample from a patient and sending it to be tested at a central laboratory, resulting in a lengthy delay for treatment. While the patient is waiting for the results, just one mosquito could transmit the disease to several other members of the community.

Data gathered by the World Health Organization shows that mosquitos cause more than 700,000 deaths annually, making them “the world’s deadliest animals”. In light of this, there is a pronounced need for medical diagnostics devices that could provide accurate results in a matter of minutes.

Enabled by their ground-breaking Immuno Magnetic Assay (IMA), Taiwan- and Denmark-based BluSense place future technology in the hands of healthcare professionals today.

By combining state-of-the-art Scandinavian bio-engineering and medical device design with first-rate Taiwanese hardware, software and manufacturing engineering, BluSense has created a breakthrough diagnostic system for detecting infectious diseases.

2020

Since its incorporation in 2014, BluSense has rapidly grown from three founders to a large team of qualified scientists and engineers around the globe. A core of experienced and dedicated professionals with a solid scientific background, all driven by one goal - to improve the life of patients through accurate and fast diagnostics.

Investors from Taiwan and Europe, as well as a strong global network of partners, empower BluSense to expand their portfolio of ViroTrack tests and diagnose even more infectious diseases over the coming years.

Quality stamp

BluSense has developed powerful technology and at the same time a commitment to provide healthcare professionals with the highest quality performance devices.

By building quality into all steps: from design to manufacture, release to delivery of products, BluSense offers in vitro diagnostics devices that meet international standards for safety, accuracy and superior clinical performance.

In 2017, BluSense achieved certification according to the requirements of ISO 13485:2016, the standard for quality management systems in the medical device industry.

The company’s quality management system provides the tools to meet and even exceed the expectations of customers. BluSense devices are CE marked in compliance with the European IVD Directive (98/79/EC).

ViroTrack portfolio & Roadmap

What is ViroTrack®?

ViroTrack® is a line of hand-fitting, single-use cartridges containing nanoparticles and microfluidic structures - the two building blocks of BluSense patented IMA technology. To receive the results of the test, you need only a single drop of blood.

ViroTrack® and BluBox® can be handled by one health care professional and requires only 20 seconds of hands-on time. This allows healthcare professionals to provide patients with fast and accurate diagnostic test results.

. High reproducibility (low CV%)

. Low Limit of Detection (LoD)

. Minimal lot-to-lot variation

. The same level of accuracy for venous whole blood (EDTA, heparin), serum, plasma and capillary blood

. Quantitative numerical results

ViroTrack® cartridges are suited for single assay tests (acute, serology) and as combo tests. The ViroTrack® line has been designed, developed, tested, and manufactured in one of the world’s leading life-science clusters - Medicon Valley - in Copenhagen, Denmark.

Blood inlet assures smooth loading of the sample

Area for hand-written patient ID

Gripping area guarantees secure holding of the cartridge

Nanoparticles assure accurate test results

QR code contains all test and assay information

2020

Proven diagnostics from a single drop of blood

There are many companies that have attempted to diagnose infectious diseases from a single drop of blood. Unlike many of them, BluSense technology is evidence-based and peer-reviewed in more than 20 scientific publications. Capillary blood dengue infection identification has been validated in a 500-patient study conducted in Malaysia, which demonstrates ViroTrack®’s excellent correlation across serum, venous blood and capillary blood.

Integrated microfluidics allow ViroTrack® + BluBox® to perform fully automated plasma separation and requires only one drop of blood to provide accurate results in a matter of minutes. The unique aspect of ViroTrack® is that the integrated sample micro-centrifugation gives over 97% agreement between results from whole blood (WB) and serum.

Advantages of capillary blood over venous blood:

. Easy to collect (venipuncture can be difficult, especially in infants)

. Taking the sample is minimally invasive and causes less pain

. ViroTrack® tests can be run after less than 15 minutes of training

. Results can be obtained in as little as 10 minutes

ViroTrack portfolio & Roadmap

ViroTrack Acute Dengue NS1 Ag V1 is available without sample collection pipettes

Sample Collection Pipettes (30μL)

ViroTrack Acute Dengue NS1 Ag V2

2020

Catalog number - 01VTA02-25

Sample type - S/P, WB, Capillary WB

Sample volume - 30 μL

Shelf-life - 15 months

Storage temperature - 2-8 °C

Sample-to-answer time - 10 min

Numerical results in IMA units

ELISASerum 95.1 % 92.0%

ELISAVenous blood 96.8% 96.8%

ELISACapillary blood 100% 97.1%

Sample Reference Specificity Sensitivity

Test Performance

Dengue NS1 Ag

0 23.0 27.0 100

POSITIVE

82.31 Published in BMC, Infectious diseases, 2020, Chong et al.

ViroTrack Acute Dengue NS1 Ag 1, ², ³, ⁴ is an Immuno Magnetic Assay (IMA) cartridge for the semi-quantitative detection of dengue virus NS1 antigen in human serum, plasma or whole blood. The test is used as an aid for diagnosing an early acute dengue infection.

ViroTrack Acute Dengue NS1 Ag V1 available - V2 coming soon

PP

P

2 PLOS Neglected tropical diseases, Alejo-Cancho et al.

³ International Journal of Research in Medical Sciences, Roy et al.

⁴ ASM Sc. J, Chong et al.

ViroTrack portfolio & Roadmap

Loading Pipettes (50 μL)

ViroTrack Sero Dengue IgG/lgM Ab Kit

Sample Dilution Buffer Vials

Sample Collection Pipettes (10 μL)

2020

Catalog number - 01VTS01-25

Sample type - S/P, WB, Capillary WB

Sample volume - 10 μL

Shelf-life - 15 months

Storage temperature - 2-30 °C

Sample-to-answer time - 12 min

Numerical results in IMA units

ViroTrack Sero Dengue IgG/IgM Ab is an in vitro IMA kit for the semi-quantitative testing of human anti-dengue virus IgG and IgM antibodies in venous whole blood, serum or plasma.

ViroTrack Sero Dengue IgG/IgM Ab Kit Available for research-use only

0

0

100

100

85.8

31.5

pos

Dengue IgG

Dengue IgM

posELISADengue IgG 95%

ELISADengue IgM 82%

Reference Specificity Sensitivity

Test PerformanceP

ViroTrack

>90%*

>90%*

*External studies ongoing

ViroTrack portfolio & Roadmap

Sample Collection Pipettes (30 μL)

Dropper (3 ml)

ViroTrack Combo Dengue Ns1 lgG/IgM Ag+Ab Kit

2020

Catalog number - 01VTC01-25

Sample type - S/P, WB, Capillary WB

Sample volume - 40 μL

Shelf-life - 15 months

Storage temperature - 2-30 °C

Sample-to-answer time - 12 min

Numerical results in IMA units

ELISASerum

ELISAVenous blood

ELISACapillary blood

Sample Reference Specificity Sensitivity

Test Performance

*Estimates based on internal verification studies. External studies ongoing

ViroTrack Combo Dengue IgG/IgM Ag+Ab is an in vitro IMA kit for the semi-quantitative testing of human dengue virus NS1 antigen and anti-dengue virus IgG and IgM antibodies in venous whole blood, serum or plasma.

ViroTrack Combo Dengue NS1/IgG/IgM Ag+Ab Kit Coming soon

0

0

0

100

100

100

50.1

45.2

41.3pos

pos

Dengue NS1

Dengue IgG

Dengue IgM

pos>95%*

>95%*

>95%*

>95%*

>95%*

>95%*

ViroTrack portfolio & Roadmap

Loading Pipettes (50 μL)

Sample Dilution Buffer Vials

ViroTrack Sero Zika lgG/IgM Ab Kit

Sample Collection Pipettes (10 μL)

2020

Catalog number - 02VTS01-25

Sample type - S/P, WB, Capillary WB

Sample volume - 10 μL

Shelf-life - 15 months

Storage temperature - 2-30 °C

Sample-to-answer time - 12 min

Numerical results in IMA units

ViroTrack Sero Zika IgG/IgM is an IMA kit for the semi-quantitative detection of human IgG and IgM antibodies directed against Zika virus in human whole blood, serum or plasma. The kit is used as an aid for diagnosing Zika virus infection.

ViroTrack Sero Zika IgG/IgM Ab Kit 2 Available for research-use only

ELISAZika IgG

ELISAZika IgM

ViroTrack Reference Specificity Sensitivity

Test Performance2

0

0

100

100

45.2

50.1

pos

Zika IgG

Zika IgM

pos62%*

96%*

86%*

96%*

2 Published in MDPI, 2020, Liao et al.

ViroTrack portfolio & Roadmap

Loading Pipettes (50 μL)

Sample Dilution Buffer Vials

ViroTrack Sero COVID-19 IgA+IgM/IgG Ab

Sample Collection Pipettes (10 μL)

2020

Catalog number - 03VTS01-25

Sample type - S/P, WB, Capillary WB

Sample volume - 10 μL

Shelf-life - 15 months

Storage temperature - 2-8 °C

Sample-to-answer time - 13 min

Numerical results in IMA units

ViroTrack Sero COVID-19 IgA+IgM/IgG Ab is an IMA kit for the semi-quantitative detection of human IgG and IgA+IgM antibodies directed against SARS-CoV-2 virus in human whole blood, serum or plasma. The kit can be used as an aid to the diagnosis of SARS-CoV-2 virus infection.

ViroTrack Sero COVID-19 IgA+IgM/IgG Ab

Days from symptoms onset to blood col-lection

PCR results

9-14

>14 days

POS

POS

ViroTrack Sero COVID-19 IgA+IgM/IgG Ab

IgA+IgM (+) IgG (+) IgA+IgM/IgG (+)

N/A

10/11 (90.9%)

18/21 (85.7%)

28/32 (87.5%)

9/11 (81.8%) 10/11 (90.9%)

18/21 (85.7%)

27/32 (84.4%)

19/21 (90.5%)

29/32 (90.6%)

BluSense is a Denmark and Taiwan based company, continuously striving to improve patient care through accurate and fast diagnosis of life-threatening infectious diseases. Find your local distributor at www.blusense-diagnostics.com

DRIVEN BY VISIONARIES, POWERED BY SCIENTISTS

T: +45 39 17 97 14E: info@blusense-diagnostics.com

Fruebjergvej 3DK-2100 Copenhagen, Denmark