Savyon Diagnostics Ltd. of Ashdod at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
Manufacturers

Savyon Diagnostics Ltd.

3 Habosem Street, 7761003 Ashdod
Israel

Telephone +972 8 8562920
Fax +972 8 8523176
info@savyondiagnostics.com

Hall map

MEDICA 2017 hall map (Hall 3): stand F09

Fairground map

MEDICA 2017 fairground map: Hall 3

Contact

Elana Biton

Our products

Product category: Bacteriology - Infectious immunology

Savvygen Extractor


SavvyGEN Automated DNA/RNA Ultra-Fast Extractor
 
Fully Automated Extraction
-Walk away system

High Throughput
-48 Specimens at one run
-48 Extractions in 15 minutes

Pre-filled Cartridge type of Reagent
– Eight or 24 Extraction Cartridge
-All Cartridge can be used simultaneously without and change of Hardware and software format

Safety
-UV Lamp/Auto door Lock

7’ Touch Screen based User interface
-Easy to operate without training
-Pre-programmed and User define protocols

Dimension
-364mm(W) x 386mm(H) x 420mm(D)
-25 kg

 

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Product category: Bacteriology - Infectious immunology

Savvygen™ Flu A, Flu B & RSV

The Savvygen™ Flu A, Flu B & RSV test allows the qualitative detection of Influenza A (Flu A), Influenza B (Flu B) and/or Human Respiratory Syncytial Virus (RSV) by real time RT-PCR in Nasal swab, UTM. The product is intended for use in the diagnosis of Flu A, Flu B and/or RSV alongside clinical data of the patient and other laboratory tests outcomes

The Savvygen™ Flu A, Flu B & RSV test is based on amplification of highly conserved fragments in the M1 gene (Flu A and Flu B) and in the N gene (RSV). Following extraction of viral RNA, the conserved fragments are reversely transcribed into cDNA in a primer-specific manner (Figure 1a). Reverse transcription is followed in a “one-pot reaction” by Taq Polymerase Chain Reaction (PCR). The assay is based on the 5’→3’ exonuclease activity of Taq DNA Polymerase . A fluorophore/quencher dual-labeled probe is annealing to an internal specific sequence. Upon primer elongation, Taq DNA Polymerase displaces and hydrolyzes the probe, thus releasing and activating the fluorophore. The presence of Flu A, Flu B and RSV is detected by an increase in observed fluorescence during the reaction. The resulting increase in fluorescence signal is proportional to the amount of amplified product in the sample and detected by the real-time PCR instrument.
The Savvygen™ Flu A, Flu B & RSV test is a ready-to-use assay containing in each well all the necessary reagents for the reaction in a stabilized format. An internal control allows the identification of a possible inhibition of the reaction. 



 

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Product category: Bacteriology - Infectious immunology

Savvygen™ B. pertussis

The Savvygen™ B. pertussis test allows the qualitative detection and differentiation of Bordetella pertussis, Bordetella parapertussis and/or Bordetella holmesii by real time PCR in respiratory samples. The product is intended for use in the diagnosis of Bordetella alongside clinical data of the patient and other laboratory tests outcomes.

The genus Bordetella bacteria are gram negative bacilli which are isolated from the upper respiratory tract. Bordetella pertussis is the main causative agent of whooping cough, although Bordetella parapertussis, can also produce the disease, but with a milder symptomatology. Additionally, Bordetella bronchiseptica and Bordetella holmesii have been identified as causing respiratory tract diseases with clinical manifestations similar to that of the pertussis syndrome but mainly in immunocompromised individuals The estimated incidence of these disease worldwide ranges from 30 to 50 million cases causing about 195,000 deaths a year. Most cases occur in developing countries where vaccination programs do not exist. In developed countries, despite the dramatic decrease in the incidence of this disease since the introduction of vaccination in the 1950s, a global resurgence of the disease has been observed in the last two decades, despite having Vaccination and high vaccine coverage. Isolation of B. pertussis in culture is definitive for diagnosis, and although the low sensitivity (50%) remains the diagnostic reference method. PCR allows rapid diagnosis and enhances culture sensitivity.

The Savvygen™ B .pertussis test is a ready-to used test which contains in each well all the necessary reagents for real time PCR assay in a stabilized format. In addition, an internal control allows the detection of a possible reaction inhibition. The amplification of the target sequence is detected through the FAM channel whereas the internal control (IC) in HEX channel.

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Product category: Bacteriology - Infectious immunology

NanoCHIP microarray

NanoCHIP Technology – Overview
The heart of our technology is the NanoChip® electronic microarray; a tiny, bio-compatible silicon chip capable of rapid identification and precise multiplexed analysis of nucleic acids (DNA/RNA).

Naturally, DNA and RNA are negatively charged, thus by applying a positive current to specific electrodes on the chip, the system is capable of addressing such molecules to specific electrodes.

The NanoChip® system is an automated, multi-purpose instrument which is used for clinical molecular diagnostics. Clinical microbiology, genetics/cytogenetics and pathology laboratories use this convenient platform to identify pathogenic infections, carriage of genetic disorders, predisposition to diseases and response to pharmaceutical therapies.

The NanoCHIP® technology is intended for those users that require:

Medium-to high throughput
Multiplex molecular testing (over 4 markers/sample)
Automation
Simplicity
Full LIS connectivity
Thus, this innovative technology is suited for molecular laboratories in hospitals as well as reference and research laboratories and private molecular screening laboratories.

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Product category: Bacteriology - Infectious immunology

NanoCHIP® ZIKV/DENV/CHIKV

he NanoCHIP® ZIKV/DENV/CHIKV panel performed on the NanoCHIP® system, is an automated qualitative in vitro diagnostic test as an aid to the evaluation of infections with zika, dengue (I-IV) and chikungunya viruses in human serum and plasma.

Zika, dengue, and Chikungunya virus are common in tropical regions. These viruses are spread and transmitted to people primarily through the bite of an infected Aedes species mosquito. Upon infection, common symptoms include, arthralgia, myalgia and conjunctivitis. As both the transmission vector and clinical symptoms are similar, it is crucial to differentiate between Zika, dengue, and Chikungunya at an early stage.

Zika virus, is a RNA flavivirus transmitted through daytime-active Aedes mosquitoes, such as A. aegypti and A. albopictus. The name originates from the Zika Forest in Uganda, where the virus was first isolated in 1947. The infection, known as Zika fever, often causes none or only mild symptoms and is treated by rest. However Zika fever in pregnant women can cause abnormal brain development of the fetuses by mother to child transmission which may result in miscarriage or microcephaly. Since the 1950s, it has been known to occur within a narrow equatorial belt from Africa to Asia. In 2014, the virus spread eastward across the Pacific Ocean to French Polynesia than to Ester Island and in 2015 to Mexico, Central America, the Caribbean, and South America, where the Zika outbreak has reached pandemic levels. The illness cannot yet be prevented by drugs or vaccines.

Dengue virus, is a RNA flavivirus transmitted through daytime-active Aedes mosquitoes, such as A. aegypti and A. albopictus. Symptoms typically begin three to fourteen days after infection. This may include a high fever, headache, vomiting, muscle and joint pains, and a characteristic skin rash. Recovery generally takes less than two to seven days. In a small proportion of cases, the disease develops into the life-threatening dengue hemorrhagic fever, resulting in bleeding, low levels of blood platelets and blood plasma leakage, or into dengue shock syndrome, where dangerously low blood pressure occurs. The virus has four different types; infection with one type usually gives lifelong immunity to that type, but only short-term immunity to the others. Subsequent infection with a different type increases the risk of severe complications. Dengue has become a global problem since the Second World War and is common in more than 110 countries. Each year between 50 and 528 million people are infected and approximately 20,000 die.

Chikungunya virus, is an RNA virus related to the alphavirus genus, and Togaviridae family. The virus is passed to humans through daytime-active Aedes mosquitoes, such as A. aegypti and A. albopictus. The disease features the sudden onset of fever two to four days after exposure. The fever usually lasts two to seven days, while accompanying joint pains typically last weeks or months but sometimes years. The mortality rate is a little less than 1 in 1000, with the elderly or those with underlying chronic medical problems most likely having severe complications. Animal reservoirs of the virus include monkeys, birds, cattle, and rodents. This is in contrast to Dengue, for which primates are the only hosts. Since 2004, the disease has occurred in outbreaks in Asia, Europe and the Americas

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Product category: Bacteriology - Infectious immunology

NanoCHIP® HPV (Human Papilloma Virus) Screening Panel

The NanoCHIP® HPV (Human Papilloma Virus) Screening Panel performed on the NanoCHIP® system is an automated qualitative in vitro diagnostic test for detection of 18 High-Risk and 2 Low-Risk HPV subtypes in clinical specimens. The HPV screening kit allows genotyping for high-risk HPV subtypes 16 and 18, simultaneous detection of High-Risk HPV types 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82 and simultaneous detection of the Low-Risk HPV subtypes 6 and 11.

An increasing number of malignancies are directly or indirectly the result of viral infection. Cervical cancer is the third most common cancer among woman and the second female cancer-related cause of death worldwide. Each year appears nearly half a million new cases and 275.000 women die from this cause. It has been extensively proven that persistent infection of the human Papillomavirus (HPV) is necessary for the development of cervical intraepithelial lesions and invasive carcinoma. HPV is the most common transmitted infection in United States with an estimated 6.2 million new HPV infections reported annually.

The NanoCHIP® HPV Screening assay was developed in order to detect 18 types of the most prevalence high risk types and two of the most common low risk types

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Product category: Bacteriology - Infectious immunology

Haptoglobin (Hp) Typing ELISA

The Haptoglobin (Hp) Typing ELISA is intended for use for diabetic patients only, for the qualitative determination of Hp phenotypes (Hp 1-1, Hp 2-1, or Hp 2-2) in human serum/plasma, to be used in conjunction with clinical evaluation and patient assessment as an aid in predicting risk of coronary arterial and cardiovascular disease.

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Product category: Bacteriology - Infectious immunology

CoproStrip™ C. difficile GDH + Toxin A + Toxin B

The CoproStrip™ C. difficile GDH + Toxin A + Toxin B is a  rapid chromatographic immunoassay combo card for the simultaneous qualitative detection of Clostridium difficile Glutamate Dehydrogenase (GDH), Toxin A and Toxin B in human faeces that aids in the diagnosis of C.difficile infection.

The gram-positive anaerobic bacillus Clostridium difficile is the leading causative agent of antibiotic-associated diarrhea and pseudomembranous colitis. This pathogen is capable of causing disease that could be severe or fatal if not diagnosed on time and treated. Exposure to antibiotics is the major risk factor for C. difficile infection. Infection can develop if the normal gastrointestinal flora is disrupted by antibiotic therapy and a person acquires toxin-producing C. difficile, typically via the fecal-oral route. C. difficile’s key virulence factors are toxin A and toxin B. These toxins show high sequence and functional homology. Toxin A has been described as a tissue damaging enterotoxin which attracts neutrophils and monocytes and toxin B as a potent cytotoxin that degrades the colonic epithelial cells. Most virulent strains produce both toxins, however, toxin A negative/toxin B positive strains are also capable of causing disease. All strains of C. difficile produce high levels of GDH. Therefore, C. difficile’s GDH enzyme is considered a very good antigen marker for detection of this organism. The CoproStrip™C. difficile is a qualitative immunoassay for detection of Clostridium difficile Glutamate Dehydrogenase (GDH), Toxin A and Toxin B in human fecal specimens.

CoproStrip C. difficile test features:

Results obtained within 10 min
Simultaneous detection of both the C. difficile antigen, Toxin A and Toxin B (3 in one)
User friendly with minimal hands-on time. Only 1 min. of set-up
Toxin A and Toxin B differentiation
Compatible to the guidelines recommendation of GDH screening in combination with toxin testing to improve sensitivity.

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Product category: Bacteriology - Infectious immunology

H. pylori saliva test

The H. pylori saliva test is a one step immunochromatographic assay for the rapid detection of H. pylori antigen in human saliva.

Physicians currently diagnose H. pylori infections with endoscopy, blood tests and breath tests. Endoscopy, the gold standard is invasive, expensive and can miss H. pylori infections if a biopsy sample from one part of the stomach does not contain the bacteria. Blood tests detect antibodies to H. pylori, but these antibodies can persist for up to a year after the bacteria are eradicated, making it impossible for physicians using blood tests to quickly determine if a patient’s treatment succeeded. Breath tests capitalize on the fact that H. pylori contains abundant urease and can rapidly metabolized urea, releasing CO2 and NH3. To perform the test, physicians have their patient swallow a capsule full of urea labeled with the radioactive isotope C14. If the patient has an H. pylori infection, the bacteria will metabolize the urea and soon the patient’s expired CO2 will have a higher than normal concentration of the radioactive carbon isotope. To collect the labeled CO2, the patient breathes into a mylar balloon.

The laboratory can quantitate the number of C14 counts with a liquid scintillation counter. Breath tests have their disadvantages in that the equipment is very expensive and not available in some cities as well as can miss H. Pylori in oral cavity and esophagus.

The H. pylori saliva test is an immunochromatographic assay, which utilizes unique antibodies to selectively identify H. pylori in saliva for oral infection.

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Product category: Bacteriology - Infectious immunology

QuickStripe™ Chlamydia Ag

The QuickStripe™ Chlamydia Ag is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine specimens to aid in the diagnosis of Chlamydia infection

Chlamydia trachomatis is the most common cause of sexually transmitted venereal infection in the world. It is composed of elementary bodies (the infectious form) and reticulate or inclusions bodies (the replicating form). Chlamydia trachomatis has both a high prevalence and asymptomatic carriage rate, with frequent serious complications in both women and neonates. Complications of Chlamydia infection in women include cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID) and increased incidence of ectopic pregnancy and infertility. Vertical transmission of the disease during parturition from mother to neonate can result in inclusion conjunctivitis pneumonia. In men, complications of Chlamydia infection include urethritis and epididymitis. At least 40% of the nongonococcal urethritis cases are associated with Chlamydia infection. Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are asymptomatic. Traditionally, Chlamydia infection has been diagnosed by detection of Chlamydia inclusions in tissue culture cells. Culture method is the most sensitive and specific laboratory method, but it is labor intensive, expensive, long (48-72 hours) and not routinely available in most institutions.

The QuickStripe Chlamydia Ag is a rapid test to qualitatively detect the Chlamydia antigen from female cervical swab, male urethral swab and male urine specimens, providing results in 10 minutes. The test utilizes antibody specific for Chlamydia to selectively detect Chlamydia antigen from female cervical swab, male urethral swab and male urine specimens.

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Product category: Bacteriology - Infectious immunology

QuickStripe Strep A

The QuickStripeTM Strep A is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigen that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis. Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess. Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.

The QuickStripe Strep A is a rapid test to qualitatively detect the presence of Strep A antigen in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen.

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Product category: Bacteriology - Infectious immunology

QuickStripe™ Strep B

The QuickStripe™ Strep B is a rapid visual immunoassay for the qualitative, presumptive detection of Group B Streptococcus (GBS) antigens in specimens taken from vaginal or rectal swabs of pregnant women, or general swabs from newborn. This kit is intended for use as an aid in the diagnosis of Strep B infection

Group B Streptococci (GBS) or Streptococcus agalactiae are among the most frequent causes of life-threatening infections in neonates. Between 5% and 30% of all pregnant women are colonized with GBS1 Several recent studies have shown that the intrapartum treatment of GBS-colonized women significantly reduces the incidence of GBS-caused sepsis. 2-4 The US Center for Disease Control and Prevention (CDC) recommends routine examination for Group B streptococcus between the 35th and the 37th week of pregnancy. A CDC study has shown that routine examinations is 50% more effective than the use of antibiotics for pregnant women with clinical risk factors. Standard culture methods require 24 to 48 hours, and the results may not be available soon enough for efficient treatment. Thus, methods utilizing more rapid screening techniques are required.

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About us

Company details

Savyon Diagnostics develops, manufactures and markets high quality diagnostic kits and systems for the detection of Infectious Diseases and Genetic Screening for more than 30 years through a worldwide network of over 80 distributors.

Savyon Diagnostics is a member of the Gamida for Life group of companies, based in the Netherlands, which is engaged in Healthcare related operations worldwide.

Savyon Diagnostics tests are based upon various immunological and molecular biology techniques (Micro Arrays, RT-PCR, ELISA, MIF, IPA, Lateral Flow etc.) and also maintains multiple patents related to these products. The company possesses the unique “know how” of producing quality core biologicals including: antigens, antibodies and nucleic acid-based probes, while using cutting edge technology to manufacture the products to the high standards that laboratories and research institutions have come to depend upon.

Savyon Diagnostics is accredited with the highest international quality standards of research, development and manufacture, including ISO 13485. The company’s products are all CE-IVD certified and those products sold in the USA, China, Brazil and Australia are FDA 510(k), CFDA, ANVISA and TGA approved, respectively.

Most of Savyon Diagnostics products are developed by our experienced and skilled R&D team who maintain close relationships with international key opinion leaders and academic institutions. Building on its innovative R&D capabilities, Savyon Diagnostics has recently introduced the novel bench-top microarray system the NanoChip®XL analyzer that enables fully automated high throughput testing of DNA/RNA.

Savyon Diagnostics has recently established an Analytical Services unit. The unit complies with GMP guidelines as required by the International Conference on Harmonization (ICH) for active pharmaceutical ingredients. Glycoanalysis services include:

  • N-link glycan analysis by HPLC
  • O-link glycan analysis by HPLC
  • Profiling and quantitative analysis of sialic acid (NeuAc and NeuGc)
  • Quantitative monosaccharaides analysis
The Analytical Unit complements the wide range of services offered by Savyon to the pharma, biotech, IVD and life sciences community. Other services include assay development, contract manufacturing and logistics, as well as QA and RA consulting.

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