Products

Currently Genomtec is developing its technology in two areas:

1. Mobile platform forPoCT genetic (Point-of-Care testing for)consulting rooms, clinics, hospitals, pharmacies:
1.1. Genomtec ID – planned commercialization: mid-2022.
1.2. Genomtec Tumor – – planned commercialization: 2024+.

2. Novel RT-LAMP genetic tests for use in medical diagnostic labs:
2.1. Ultrafast two-gene test Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo-Kit, which has been registered and approved for sale in Europe and can be distributed on other continents.
2.2. The world’s first genetic diagnostic test for the detection of SARS-CoV-2 directly from a saliva sample Genomtec® SARS-Cov-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit registered for sale in the European Union (also bi-genic).

Genomtec ID – Mobile platform for genetic diagnostics

Genomtec ID is a flagship technological solution currently under development, which will offer patients ultrafast mobile genetic diagnosis utilizing SNAAT®. The Genomtec ID platform makes it possible to run a diagnostic process at point of care, i.e., public clinics, consulting rooms, hospital, pharmacies and emergency wards, without the need of complicated and time-consuming handling by skilled personnel in the laboratory.

The platform includes an analyzer and reaction card with integrated genetic tests and provides multiplexing capability of up to five genetic targets at the same time. SARS-CoV-2 will be included in one of the Genomtec ID’s diagnostic panels intended for identification of respiratory diseases.

Currently, the Genomtec ID platform is at the industrialization stage in collaboration with the international CDMO partner in order to prepare the system for mass production. The manufacturable version of the microfluidic card is in its final stage of development. It is being created using injection moulding technology resulting from the experience of the German company, Microfluidic ChipShop.

It is expected that the POC molecular diagnostic industry will increase by approx. 14% CAGR by 2024, while the POC molecular diagnostic market is expected to be valued at USD 3.9 billion in 2024.

Nowadays, molecular diagnostics requires the user to know how to handle diagnostic equipment and how to correctly prepare the sample. SNAAT® combines mobility with incredible ease of use. The intuitive and simple diagnostic platform can be handled by health care professionals with no laboratory training, i.e., nurse, doctor, paramedic.

Technology properties

Specificity

Up to 100%

Sensitivity

Up to 100%

Speed

Time from sample to result
– as quickly as 15 min

Groundbreaking ease of use

You only need to apply a single drop of biological material, the test does not require prior sample preparation

Wide range of applications

The analyzer may be used by health care professionals, including GPs, pediatricians, gynecologists, nurses and paramedics

Extreme cost-effectiveness

Cost-effectiveness per test is comparable to other available technologies

Multiplexing

Up to 5 targets during 1 test

Global database

In the future, the analyzers shall provide anonymous information on the global outbreaks of individual diseases.

Handling of the intuitive and simple Genomtec ID platform

1

Sample the biological material

2

Apply the biological material into the reaction card

3

Place the reaction card in the device

4

Start the test

5

Test results available as quickly as 15 minutes

Genomtec ID – Mobile platform for genetic diagnostics – leaflet

Genomtec Tumor / Immunogenetics

Currently, the Genomtec Tumor project is in its early phase, adopting SNAAT®-based solutions that could be used to quickly identify neoplastic mutations or mutations that are of prognostic value in neoplastic disease, as part of companion diagnostics (CDx) solution. The SNAAT® method shall be adapted for near-patient testing of neoplastic mutations and will allow quick implementation of personalized treatment. If combined with protein markers, it may be possible to create a diagnostic platform for screening tests and/or highly specific antigen identification in immunogenetic testing.

The early phase of the project, especially in comparison to Genomtec ID and laboratory tests, makes the project dependent on the success of other projects or acquisition of an industry partner, or obtaining grant funding for further development of the project.

Currently, the oncological molecular diagnostics market is valued at approx. USD 2.6 billion with anticipated growth rate of 18.46% CAGR by 2024 and expected to be valued at USD 5.12 billion. It is also worth noting that in Poland the waiting time for BRCA1&2 gene test results lasts between 2 to 4 weeks, while Genomtec Tumor could reduce it to several hours.

Novel RT-LAMP genetic tests for use in diagnostic laboratories

As part of this project, Genomtec developed and launched on the market novel laboratory diagnostic kits intended for conducting qualitative tests to detect SARS-CoV-2 RNA in various biological samples from patients with suspected COVID-19 infection. In the future, it will also be possible to detect other pathogens. The test kits include an optimized composition of reagents, specific enzymes and proprietary LAMP reaction primers, while the RNA amplification reaction is conducted using an isothermal method, i.e. RT-LAMP or LAMP. This ensures signal detection for positive clinical samples after only 11 minutes for SARS-CoV-2 in the amplification process (with Duo kit) and its compatibility with standard Real-Time PCR thermal cyclers with green (FAM) fluorescence detection channel.

Currently Genomtec has two types of registered and commercially available two-gene diagnostic kits: Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo-Kit, which has been approved for sale in Europe and can be distributed to other continents, and Genomtec® SARS-Cov- 2 EvaGreen® Direct-RT-LAMP CE-IVD Kit, which enables identification of SARS-CoV-2 infection directly from the patient’s saliva.
The innovative test will provide patients with greater comfort due to lack of swabbing, e.g. from the nasopharynx. The possibility of testing using saliva will also reduce the risk of virus’ contraction by the personnel collecting the sample, additionally sampling does not require specialized skills. Utilization of the Direct-RT-LAMP Kit makes it possible to receive test’s results in just several minutes from the time the sample was received by the laboratory. The ultrafast test for COVID-19, which detects all currently identified SARS-CoV-2 variants.

The value of the market of molecular diagnostics, which is still largely connected to stationary lab testing, is estimated to exceed USD 3.82 billion, with a CAGR of +6.16%. The estimated number of tests for SARS-CoV-2 in 2020 is expected to reach USD 329 billion.

Currently, laboratory genetic diagnostics of SARS-CoV-2 utilizes the RT-PCR method, namely its type Real-Time Reverse Transcription PCR. In this method, virus genetic material (RNA) is transcribed to complementary DNA (so-called cDNA) by an enzyme, reverse transcriptase combined with a cDNA multiplication stage using another enzyme – polymerase. The detection mechanism is usually based on molecular probes or fluorescent dyes. We can assume that the average lab time required for Real-Time RT-PCR reaction for detection of such pathogen as SARS-CoV-2 is 90 minutes, and often can be longer, depending on the applied enzymes and the performance of Real-Time PCR device. The Real-Time RT-LAMP makes it possible to analyze the same sample in around 30 minutes using the same laboratory equipment.

Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo-Kit

Benefits for testing laboratories with the Genomtec® RT-LAMP Duo Kit:

  • fast and economically effective isothermal RNA amplification technology with high specificity
  • detection of all variants of the SARS-CoV-2 virus,
  • 40% savings in amplification reaction time,
  • 11 primers in the kit ensuring its high specificity and speed,
  • ease of interpretation – reading the reaction result in one FAM channel.

Instructional video showing all steps of using the Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IV Duo-Kit in the laboratory to detect the presence of SARS-CoV-2.

Genomtec RT-LAMP tests process manual

1

Sampling

A sample is taken from the saliva, oropharyngeal or nasopharyngeal swabs

2

Transportation

The properly secured sample is transferred to a diagnostic lab
(up to 24 hours)

3

RNA isolation

RNA is isolated and purified from the biological material, manually or automatically.
Direct-RT-LAMP tests require preparation of the lysate and RNA-enriched supernatant.

4

RT-LAMP amplification

RNA is transcribed to cDNA with simultaneous amplification by RT-LAMP reaction

5

Test results

A positive result may be obtained from a clinical sample even just after 11 minutes – when the signal exceeds the fluorescence threshold

Genomtec® SARS-Cov-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit

Genomtec® SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit is Real-Time Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) test for qualitative detection of nucleic acid from two genes of SARS-CoV-2 virus with a streamlined biological sample processing that is CE-IVD labelled for diagnostic use in the EU.* It features rapid RNA isolates preparation in conjugation with the simultaneous RNA transcription and cDNA amplification utilizing standard Real-Time PCR instrument workflow (detection in FAM channel), with sample to result time in approx. 50 minutes of which amplification stage takes only 40 minutes.

CLINICAL EVALUATION
92.31% sensitivity and 100% specificity confirmed when compared to Real-Time RT-PCR CE-IVD test.
Validated specimen types include saliva, nasopharyngeal and oropharyngeal dry-swabs. Clinical validation was performed on saliva samples (as per IFU Section 9.5; dry swab processing is described in Section 6.2 of IFU).

VARIANTS RECOGNIZED
Genomtec ® Direct-RT-LAMP Kit can detect the wild type virus as well as mutant strains of SARS-CoV-2 including but not limited to: B.1.1.7 (EPI_ISL_723044), Breton (hCoV-19/France/ BRE-IPP04233/2021) (EPI_ISL_1259297), P1 (EPI_ISL_792680), B. 1.351 (EPI_ISL_825139), B.1.525 (EPI_ISL_1563854), P.3 (EPI_ISL_1122452) and B.1.427 (EPI_ISL_1592298), B.1.617 (EPI_ISL_1415353).

Genomtec® RT-LAMP Direct offers multiple benefits:

  • Comfort, accuracy and speed for patients testing.
  • Increased level of safety for medical personnel.
  • Faster, easier and cost effective process for laboratories.
  • Increased efficiency and lower cost of laboratory work for healthcare system.

With Genomtec® Direct RT-LAMP we bring new quality of testing for SARS-CoV-2.

For Patients our test means:

  • greater comfort due to lack of swabbing e.g. from the nasopharynx
  • test performance regardless of SARS-CoV-2 variant present
  • faster results

For Medical Personnel it means:

  • decreased risk of exposure to infectious agent
  • no specialized skills and equipment required while sampling

For Laboratory our test means:

  • rapid biological material processing and 40 minutes isothermal amplification protocol
  • no thermal-cycling requirement
  • increased cost effectiveness (no swabs, no extensive RNA purification kit, no doctor’s swabbing)
  • obtained RNA-enriched supernatant directly used for amplification reaction setup
  • double-well, triple target assay covering highly conserved regions within N & S genes as well as internal control targeting human gene
  • superb diagnostic performance provided by eleven LAMP primers recognising fifteen conservative fragments of SARS-CoV-2 N & S genes enable specific virus detection

For Healthcare System our test means:

  • quicker laboratory turnaround time increases outbreak surveillance
  • wider population acceptance for testing due to non-invasive sampling
  • less expensive and more robust method for SARS-CoV-2 molecular testing
  • minimal laboratory experience required and possibility for fast re-training for the operator

 

PROTOCOL DIRECT KIT – increases throughput by streamlining laboratory processing

1

Sampling

Saliva sample, or throat or nasopharyngeal dry swab is obtained (5 min.)

2

Collected specimen (up to 24hs)

Collected specimen (saliva or dry swab) is transferred to the diagnostic laboratory within 24 hs

3

Lysate total RNA prep (5 minutes)

Add LysBuffer to saliva or dry swab and heat for 5 min. at 95oC to prepare RNA-enriched supernatant. Saliva / dry swab sample preparation stage with LysBuffer takes 5 minutes onto the heat block (pipetting excluded)

4

RT-LAMP amplification (40 minutes)

Purified RNA is simultaneously reverse transcribed to cDNA and amplified in LAMP technology

5

Test result

Positive clinical samples can be detected in as little as 20 minutes – when fluorescence exceeds threshold

Instruction how to use the world’s first genetic diagnostic test for the detection of SARS-CoV-2 directly from a saliva sample: Genomtec® SARS-Cov-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit.

Saliva Sample Collector

Additionally to Genomtec® RT-LAMP-Direct we offer Saliva Sample Collector Device.

Product No.: GC00A
Product Name: Saliva Sample Collector
Components:
  • Saliva collection funnel
  • 5ML single-use collection tube
  • Screwcap
Materials used: PP (polypropylene)
Sterilisation method: Radiation sterilization
Packaging: Paper-foil pouch, individually wrapped
Quantity: One item per pouch

Saliva Sample Collector Device can be used for the collection, storage and transportation of native saliva sample for clinical diagnostic purposes and does not contain any nucleic acid stabilizing solution. It is DNaze / RNaze and pyrogen free and sterilized by radiation. The product is compatible for saliva-based testing using Genomtec® SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit (cat. no.: GA00C).

The product consists of three-part:

  1. collection funnel (disposable, re-attachable)
  2. sample collection tube (5ml)
  3. screwcap (equipped with a leak-proof thread)

The product is CE-IVD marked. For saliva collection process, storage conditions and EU Representative please read the Instruction for Use (IFU).

For each product there is a downloadable document list (if it is authorized for sale)