About 3a Diagnostics

3a-diagnostics GmbH is a research-based biotechnology company located Southeast of Stuttgart, Germany, specializing in the development, production and marketing of point-of-care test systems.

3a developed the first saliva activated “in-mouth” biosensor candidates for the detection of a COVID-19 infection. The enzyme-activated biosensors are developed for real-time, low-cost and easy-to-use oral screening applications for the rapid detection of infectious diseases including COVID-19 at home or at the point-of-care.

In addition, 3a has developed a pipeline of peptide-based biosensor screening tests for bacterial and viral infectious diseases which include stomatitis, periimplantitis, periodontitis, scarlet fever, and influenza. Positive detection of the causative pathogen results in enzymatic release of an extreme (but safe) bitter compound. 3a has also designed a scalable next generation microbial-enzyme screening tool for high-throughput identification of biosensor targets to facilitate rapid development of new tests.

3a’s Product Pipeline

3a Product Pipeline
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25 minute RT-PCR rapid test Covid-ID Lab

3a’s lead product is the rapid point-of-care COVID-19 RT-PCR diagnostic test launched in Europe in April 2021.

It is part of the above mentioned definitive development, technology purchase and licence agreement between 3a and Xphyto.

Covid-ID Lab is a rapid RT-PCR test for the qualitative detection of SARS-CoV-2 based on the reverse transcriptase polymerase chain reaction (RT-PCR) method. To perform the test, Covid-ID Lab requires only a 20-minute PCR run time without prior RNA extraction as part of sample preparation. After the RT-PCR, the SARS-CoV-2 virus is detected on a test chip within 5 minutes and if SARS-CoV-2 is present, the result can be read visually immediately.

The COVID 19 RT-PCR test “Covid-ID Lab” is a mobile test that can be analyzed in a satellite laboratory without the need to send specimen away to a specialized laboratory. The test is easy to use and produces reliable results within just 25 minutes, only minimal laboratory equipment is needed.

For more information about Covid-ID Lab click here

Biosensors

3a is developing a class of next generation diagnostic tools using biosensors to optimize at-home-diagnosis as an early, self-check of diseases including COVID-19, periodontitis and scarlet fever

Improving on decades-old testing methods, 3a-diagnostics has developed a pipeline of peptide-based biosensor screening tests for bacterial and viral infectious diseases with a radically new approach to diagnostic testing. The new approach offers drastically reduced manufacturing cost per unit making it possible to meet the high demand.

The first Biosensor test for oral disease is already registered with the German authorities and is ready for partnering with wholesale distribution partners and market launch. This test dissolves on the tongue and turns bitter indicating the presence of oral inflammation after five minutes. Click here to read more.

Biosensors in development:

  • Biosensors for multiple infectious diseases (Influenza, Scarlet Fever)
  • Biosensors for multiple oral health diagnostic products (Periimplantitis, Peridontitis)

Test your health with your tongue as a sensor

The 3a-diagnostics technology utilizes one of the body’s first lines of defense—the mouth—to detect an early presence of pathogens. The technology can distinguish viral from bacterial causes of infection and allows acute inflammatory processes to be clearly differentiated from inactive pathogens. Positive detection of the causative pathogen results in enzymatic release of a clear (but safe) bitter compound within two to five minutes.

Point of Care COVID 19 Rapid Diagnostic test

The Acquisition of 3a

The acquisition creates significant commercial development and manufacturing opportunities for XPhyto as well as cost synergies and improved margins on its diagnostic products.

The acquisition secures XPhyto an experienced research and development team with a pipeline of ready-to-launch biosensor products.

The acquisition facilitates XPhyto’s aggressive expansion into the point-of-care biosensor market which is growing at 8% per annum and expected to reach a market size of $42 billion by 2028 according to a new report by Grand View Research, Inc.

XPhyto will pay 3a-diagnostics a total of EUR 3.9 million to acquire 100% of 3a-diagnostics.

XPhyto and 3a signed a definitive development, technology purchase and licence agreement, announced April 20, 2020, for the incorporation of 3a’s pathogen-specific biosensors into XPhyto’s dissolvable thin film (“ODF”) platform. On July 2, 2020, 3a and XPhyto signed an addendum to the Agreement which incorporates 3a’s RNA probes (for use in LFA test systems) and related IP into the Agreement.

The planned acquisition of 3a is expected to result in significant synergies in research and development and manufacturing; significantly improved margins for commercial products, such as the 25-minute COVID-ID Lab test; as well as expedite commercialization of products in 3a’s near-market development pipeline. 3a’s intellectual property, including patents, know-how, expertise and contracts with third parties will be transferred to XPhyto at the time of closing the acquisition. XPhyto plans to maintain, support and further develop 3a’s operations in Southern-Germany.

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Quick

2 – 5 m

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Easy

No equipment needed

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Simple

Self-check by patients

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Accessible

Can be used by anyone, anywhere at any time

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Uncomplicated

No special storage conditions required, no laboratory tests necessary

Xphyto Therapeutics lab technician

Pioneering a new concept​

No competitors using the tongue as a sensor for diagnosing diseases.

A reliable and cost-effective product providing ease of use for self-checking gives 3a a strong market position

Path to Commercialization

According to the new Medical Device Regulation in Europe, the diagnostic chewing gum qualifies for classification as a “class I non-active” device. After the preparation of the technical documentation, which provides the complete overview of the product, the approval procedure is initiated with a notified body. This classification enables a speedy approval process in any case to minimize time-to-market.

Targeting large and growing markets

Dental implants

  • Around 750,000 dental implant owners in Germany alone, every one of them a potential customer. This makes for an estimate of 3 million customers for periimplantitis diagnostics in targeted markets across Europe

Peridontitis

  • Around 1 million patients treated in Germany in 2016, equal to 1.27 % of the overall population
  • Across targeted markets this means roughly 4.5 million patients suffering from severe peridontitis

Streptococcus Pyogenes

  • Cause of diseases like scarlet fever
  • 32 million patients per year across targeted markets.
  • Diseases caused by S. Pyogenes are often painful and diagnosis takes two to three days leading to great demand for a quicker diagnosis reducing time until treatment commences
  • More expensive equipment increases cost leading to rising demand for cost-efficient alternatives to antigen screening and RNA testing

Disease detection is a multi-billion-dollar market

  • 9.4 % growth rate of PoC (Point-of-Care) market between 2016 and 2022, projected to reach $ 43 bn by 2022
  • The global market for rapid tests is projected to reach $ 39.1 bn by 2023 with a CAGR of 8.9 %
  • To secure a strong position on such a large and dynamic market Xphyto Therapeutics has signed a definitive agreement for the acquisition of 3a-diagnostics GmbH, XPhyto’s exclusive diagnostics development partner. Pursuant to the definitive agreement, XPhyto will acquire all of the outstanding shares of 3a for EUR 400,000 already paid, and EUR 3.5 million, to be paid on closing, planned for on or around October 31, 2021.

“The role of diagnostics in our lives today feels so relevant given the global pandemic. The impact innovation can have in this space at the moment is an exciting opportunity for XPhyto to explore.”

– Hugh Rogers, CEO

Scientist looking in magnifying glass XPhyto

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