Cancer Detection Tests

OncoE6™ Cervical Cancer Test

The only cervical cancer test that provides real-time results at the point of care. To find out more about our innovative flagship product, click here.

OncoE6™ Oral Test

The OncoE6™Oral Test follows the same principle as the OncoE6™ Cervical Test by directly detecting elevated levels of the cancer-causing HPV viral E6 oncoprotein. It is a simple lateral flow test yielding results in about 2.5 hours.

Worldwide, the prevalence of head-and-neck cancers is on the rise in both developed and developing countries. Historically, these diseases have been caused most often by tobacco or alcohol use. But increasingly, they are the result of an oral HPV infection (50-70% in the US due, in part, to decreasing numbers of smokers and increasing rates of oral HPV).
 
Head-and-neck cancers have a high mortality rate, and the treatments (radiotherapy, chemotherapy) are aggressive and debilitating. HPV-related head-and-neck cancers have a better prognosis than non-HPV-related cases, so it is of critical importance to determine whether or not HPV is a causal factor. The OncoE6™ Oral Test accomplishes that; if it is positive, the cancer is caused by HPV and a less harsh treatment may possibly be warranted. 
 
The OncoE6™ Oral Test has been used by clinical researchers at Hamilton University / St. Joseph Healthcare, ON, Canada, and by a prominent group in the field at the German Cancer Research Center. These studies have demonstrated that the OncoE6™ Oral Test can determine accurately whether or not a head-and-neck cancer is driven by HPV. These outcomes have been presented at intentional scientific conferences, and are pending publication.

Influenza Detection Tests

Influenza

Influenza, an RNA virus, has been responsible for global pandemics throughout human history. The 1918 “Spanish Flu” pandemic caused by H1N1 killed 50 to 100 million people. More recently, the 2009 “Swine Flu” pandemic first identified in California, also caused by H1N1, killed 18,000 people. The virus has the ability to genetically reassort, specifically by antigenic shift, and can therefore mutate into a form that compromises vaccine effectiveness and to which a naive population has no immunity.
Avian influenza H7N9 is one example which emerged in March 2013 in China, reappearing again in January 2014. Most had contact with live bird markets, but human-to-human transmission is also suspected. Although it has killed fewer than 200 people, it is has a mortality rate of 30%. Given today’s international air travel and that viruses do not respect borders, it is believed that H7N9 could spread rapidly with deadly pandemic potential.
Fast and early diagnosis plays an important role in detection and containment of  influenza pandemics. In conjunction with the United States Navy, Arbor Vita has developed rapid tests against A/H5N1 and A/H7N9 that could, unlike more equipment-intensive and complicated PCR tests, be used in such critical entry points as airports. The AV Avantage™ A/H5N1 Flu Test has received 510K clearance for sale in the United States, while the A/H7N9 Influenza Rapid Test has been authorized by the FDA under Emergency Use Authorization.
 
A/H7N9 Influenza Rapid Test
Arbor Vita’s A/H7N9 Influenza Rapid Test, which is FDA-authorized for emergency use (see Product Certification below for Conditions of Authorization), detects the NS1 protein antigen of influenza A/H7N9 virus (identified in China in 2013) from nasal swab specimens and viral cultures in patients untypeable for seasonal influenza A. The test consists of a three-line immunochromatographic assay and provides results in less than twenty minutes. This will assist healthcare providers and surveillance teams in the early detection of individuals who may be infected with A/H7N9 (line 1 and 2) or seasonal influenza A (line 1 only). The results will require verification by CDC’s real time PCR for A/H7N9 available at public health laboratories.
 
The AV Avantage™ A/H5N1 Flu Test
 FDA-cleared, rapid test for the detection of the A/H5N1 influenza virus from throat and nasal swab specimens and viral cultures. Arbor Vita received 510(k) clearance from the U.S. Food and Drug Administration in April 2009 for this test. The test requires no equipment or cold storage, is easy to use, and gives results within 30 minutes, critical features in an outbreak. The Arbor Vita AV Avantage™ A/H5N1 Flu Test utilizes proprietary PDZ technology to distinguish H5N1 from seasonal influenza A infections.
 

A/H7N9 Influenza Rapid Test

FDA-authorized for emergency use
The A/H7N9 Influenza Rapid Test is the only FDA-authorized rapid test for the specific identification of the emerging A/H7N9 influenza strain in nasal clinical specimens or viral cultures.

Arbor Vita’s A/H7N9 Influenza Rapid Test, which is FDA-authorized for emergency use (see Product Certification below for Conditions of Authorization), detects the NS1 protein antigen of influenza A/H7N9 virus (identified in China in 2013) from nasal swab specimens and viral cultures in patients untypeable for seasonal influenza A. The test consists of a three-line immunochromatographic assay and provides results in less than twenty minutes. This will assist healthcare providers and surveillance teams in the early detection of individuals who may be infected with A/H7N9 (line 1 and 2) or seasonal influenza A (line 1 only). The results will require verification by CDC’s real time PCR for A/H7N9 available at public health laboratories.
Product Description
The A/H7N9 Influenza Rapid Test contains cassettes and reagents for 10 tests:
10 Cassettes – individually wrapped
1 bottle of Lysis Buffer
10 Lysis tubes
1 vial of Positive Control
1 Quick Guide
1 Instructions For Use
Equipment required but not supplied:
Timer
Product Reference
If you have questions about this product, please use Part Number #1200000 as reference.
Product Certification
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized for use only by DoD network laboratories in the U.S. and outside the U.S., other U.S. government laboratories outside the U.S., or foreign laboratories;
• This test has been authorized for the detection of influenza A (H7N9) virus (first detected in China in 2013) only and not for any other viruses or pathogens;
• This test is only authorized for the duration of the HHS declaration of emergency that justifies this authorization, unless the authorization is revoked sooner.
Legal and Disclaimers
The buyer/user has a non-exclusive licence to use A/H7N9 Influenza Rapid Test under the FDA’s Emergency Use Authorization only.
References
• Gao, R., et al. (2013) Human infection with a novel avian-origin influenza A (H7N9) virus. N. Engl. J. Med. 368:1888–1897.
• Lam, T. T-Y., et al. (2013) The genesis and source of the H7N9 influenza viruses causing human infections in China. Nature 10;502(7470):241–244.
• Rudge, J. W., and Coker. R. (2013) Human to human transmission of H7N9. BMJ 347:f4730.
• WHO: Avian influenza A(H7N9) virushttp://www.who.int/influenza/human_animal_interface/influenza_h7n9/en/

AV Avantage™ A/H5N1 Flu Test

AV Avantage™ A/H5N1 Flu Test
FDA 510(k)-cleared
The AV Avantage™ A/H5N1 Flu Test is the only FDA-cleared rapid test for the specific detection of the A/H5N1 virus.

The AV Avantage™ A/H5N1 Flu Test is an FDA-cleared, rapid test for the detection of the A/H5N1 influenza virus from throat and nasal swab specimens and viral cultures. Arbor Vita received 510(k) clearance from the U.S. Food and Drug Administration in April 2009 for this test. The test requires no equipment or cold storage, is easy to use, and gives results within 30 minutes, critical features in an outbreak. The Arbor Vita AV Avantage™ A/H5N1 Flu Test utilizes proprietary PDZ technology to distinguish H5N1 from seasonal influenza A infections.

The Arbor Vita Avantage™ A/H5N1 Flu Test is based on the detection of the NS1 protein antigen of the influenza virus in specimens from infected individuals. It consists of an immunochromatographic assay in a lateral flow format in which a PDZ domain is used as a capture reagent and highly sensitive monoclonal antibodies are used as detection reagents. Line 1 of the Test or Test Cassette specifically binds NS1 protein from H5N1 Clades 1, 2.1, 2.2, and 2.3. Line 2 preferentially binds NS1 from the seasonal influenza A subtypes, H1N1 and H3N2. The test detects H5N1 influenza viruses originally isolated from infected humans that have been grown in culture as a low passage and spiked into a human negative sample background. The test permits samples to be characterized as H5N1-Positive or H5N1-Negative.
The AV Avantage™ A/H5N1 Flu Test Kit contains cassettes and reagents for 21 tests:
21 AV Avantage™ A/H5N1 Flu Test Cassettes
21 vials of Lyophilized Lysis Solution A
1 vial of Loading Solution B
21 vials of Lyophilized Detector Reagent C
1 vial of Positive Control
Equipment required but not supplied:
Microcentrifuge, 1.5 to 2-mL tubes, >10,000 x g
Micropipettes
Timer
Thermometer
Tube rotator, 8RPM
Product Reference
If you have questions about this product, please use Part Number #1000000 as a reference.
Product Certification
FDA 510(k)-cleared
Legal and Disclaimers
The buyer/user has a non-exclusive licence to use AV Avantage™ A/H5N1 Flu Test.
References
• Peiris, J. S., Yu, W. C., Leung, C. W., et al. (2004) Reemergence of fatal human influenza A subtype H5N1 disease. Lancet 363:617–619.
• World Health Organization. (2005) Avian influenza: Assessing the pandemic threat. WHO/CDS/2005.29.
• World Health Organization Global Influenza Program Surveillance Network. (2005) Evolution of H5N1 avian influenza viruses in Asia.Emerg. Infect. Dis. (10):1515-1521.