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DxTerity is Omicron Ready
Based on sequencing analysis the current saliva test will be just as accurate
for the new variant


DxTerity

Main Menu
 * COVID-19
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Register Kit


SARS-COV-2 CORONAVIRUS TEST


Molecular Test for the Detection of COVID-19

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Test OverviewTest DataTechnicalFAQ


SARS-COV-2 TEST (COVID-19)


WHAT IS CORONAVIRUS (COVID-19)?

COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans
causing a contagious respiratory illness. COVID-19 can present with a mild to
severe illness, although some people infected with COVID-19 may have no symptoms
at all. Older adults and people of any age who have underlying medical
conditions have a higher risk of severe illness from COVID-19. Serious outcomes
of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be
spread to others not just while one is sick, but even before a person shows
signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing,
etc.).


WHAT IS THE DXTERITY SARS-COV-2 (COVID-19) TEST

The DxTerity SARS-CoV-2 RT-PCR CE Test is an end point reverse transcription
polymerase chain reaction (RT-PCR) test followed by detection with capillary
electrophoresis (CE) intended for the qualitative detection of nucleic acid from
the SARS-CoV-2 in saliva specimens collected from any individuals determined to
be appropriate for COVID-19 testing by their healthcare provider (HCP),
including from individuals without symptoms of COVID-19.

 


IMPORTANT FACTS FOR PATIENTS

What are the symptoms of COVID-19?


 

 * Patients with confirmed COVID-19 have developed fever and/or symptoms of
   acute respiratory illness (e.g. ,cough, difficulty breathing)
 * Limited information is currently available to characterize the full spectrum
   of clinical illness associated with COVID-19.
 * Based on what is known about the virus that causes COVID-19,signs and
   symptoms may appear any time from 2 to 14 days after exposure to the virus.
 * The median incubation period is approximately 5 days, but may range 2-14
   days.
 * Patients may be asymptomatic  (without symptoms) for up to the full period of
   infection.
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Who should get tested?

 * You should be tested because your healthcare provider believes you may have
   been exposed to the virus that causes COVID-19 based on your signs and
   symptoms (e.g., fever, cough, difficulty breathing), and/or because:
 * You live in or have recently traveled to a place where transmission of
   COVID-19 is known to occur, and/or
 * You have been in close contact with an individual suspected of or confirmed
   to have COVID-19.
 * You and your healthcare provider believe there is another reason to
   investigate your COVID-19 infection status.

What does it mean to if I have a positive test result?

 * If you have a positive test result, it is very likely that you have COVID-19.
   Therefore, it is also likely that you may be placed in isolation to avoid
   spreading the virus to others. You should follow CDC guidance to reduce the
   potential transmission of disease.
 * There is a smaller possibility that this test can give a positive result that
   is wrong (a false positive result) particularly when used in a population
   without many cases of COVID-19 infection. Your healthcare provider will work
   with you to determine how best to care for you based on the test results
   along with medical history, and your symptoms

What does it mean if I have a negative test result?

 * A negative test result means that the virus that causes COVID-19 was not
   found in your sample.
 * However, it is possible for this test to give a negative result that is
   incorrect (false negative) in some people with COVID-19. You might test
   negative if the sample was collected early during your infection.  You could
   also be exposed to COVID-19 after your sample was collected and then have
   become infected. In particular, people infected with COVID-19 but who have no
   symptoms may not shed enough virus to trigger a positive test.
 * This means that you could possibly still have COVID-19 even though the test
   result is negative. If your test is negative, your healthcare provider will
   consider the test result together with all other aspects of your medical
   history (such as symptoms, possible exposures, and geographical location of
   places you have recently traveled) in deciding how to care for you. If you
   have no symptoms but have been tested because your doctor thought you may
   have been exposed to COVID-19, you should continue to monitor your health and
   let your healthcare provider know if you develop any symptoms of COVID-19. 
   If you develop symptoms you may need another test to determine if you have
   contracted the virus causing COVID-19.

When should I seek medical care?


If you develop symptoms or your symptoms get worse you should seek medical
care.  If you have the following symptoms you should seek immediate medical care
at the closest emergency room:

 * * Trouble breathing
   * Persistent pain or pressure in the chest
   * New confusion
   * Inability to wake up or stay awake
   * Bluish lips or face

What are the known and potential risks and benefits of the test?

 * Potential risks include:
   * Possible discomfort or other complications that can happen during sample
     collection.
   * Possible incorrect test result (see positive result and negative result
     FAQs above)
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   Potential benefits include:
   
   * The results, along with other information, can help you and your healthcare
     provider  make informed recommendations about your care.
   * The results of this test may help limit the spread of COVID-19 to your
     family and those you come in contact with.
   
    

Rapid test results
within 24-48 hours

Simple
saliva collection device

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DXTERITY SARS-COV-2 RT-PCR CE TEST

DxTerity SARS-CoV-2 RT PCR CE Test

The DxTerity SARS-CoV-2 RT-PCR CE Test is an end point reverse transcription
polymerase chain reaction (RT-PCR) test followed by detection with capillary
electrophoresis from Saliva Samples. The SARS-CoV-2 primers are designed to
detect RNA from SARS-CoV-2  genome from the nucleocapsid (N) gene, envelope (E)
gene, and ORF1ab region and includes controls for RNase P.

Submission #: EUA202120
Granted by FDA: 8/28/2020
Device: DxTerity SARS-CoV-2 RT-PCR CE Test

 

Assay Performance: Symptomatic Patients (nasopharyngeal and swab samples vs. 
saliva)

Positive Agreement:   97.3% (36/37); 86.2-99.5%
Negative Agreement: 90.0% (36/40); 76.9.7-96.0%

Assay Performance: Asymptomatic Patients Combined (nasopharyngeal and swab
samples vs. saliva) (1)

Positive Agreement:   84.6% (22/26);66.5-93.8%
Negative Agreement: 99.0% (513/518); 97.8-99.6%

1 There were four asymptomatic individuals which tested negative by the DxTerity
SARS-CoV-2 RT-PCR test and positive by the NP swab with the Roche cobas
SARS-CoV-2. The four samples had low viral loads at the limit of detection for
the cobas SARS-CoV2 assay.



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HIGH TEST SENSITIVITY:

 * Limit of Detection at 150 virus copies / mL
 * Sensitive assay for Symptomatic and Asymptomatic Testing
 * Proven Concordance between Saliva and Nasal input types
 * High Throughput Chemistry

 


HIGH THROUGHPUT:

 * Automated Accessioning and Data Capture
 * Automated Sample Processing of Saliva Samples
 * Fast Turn Around

SURVEY OF 25 AVAILABLE SARS-COV-2
LIMIT OF DETECTION (COPIES / ML)



 

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SIMPLE TO USE SALIVA COLLECTION:

 * Simple self-collection from home or work
 * 72 Hour Stabilization for Transport
 * Instructions and Shipping Materials included
 * SDNA-1000 Saliva Collection Device
 * Secure Bar Code Tracking of Specimen



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FREQUENTLY ASKED QUESTIONS (FAQS)

How does COVID-19 spread?


COVID-19 spreads from person-to-person. When an infected person coughs, sneezes,
or exhales air, droplets containing the virus go into the air and onto surfaces
and objects around them. Other people are exposed to the virus by breathing in
these droplets or by touching their eyes, nose, or mouth after touching infected
surfaces.

How is COVID-19 treated?


There is currently no treatment for COVID-19. Not all patients with COVID-19
will require medical attention, and most people recover within 2 weeks without
any specific treatment. For severe cases, hospitalization may be required.
Treatment focuses on managing symptoms.

Who is at high risk of getting very sick?


If you have any symptoms concerning for COVID-19 and any of the following
conditions or risk factors, which may put you at increased risk of severe
illness from COVID-19, you should consult with your healthcare provider before
using this test:

 * Chronic kidney disease
 * COPD (chronic obstructive pulmonary disease)
 * Immunocompromised state (weakened immune system) from solid organ transplant
   or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids,
   or use of other immune weakening medicines
 * Obesity (body mass index [BMI] of 30 or higher)
 * Serious heart conditions, such as heart failure, coronary artery disease, or
   cardiomyopathies
 * Sickle cell disease
 * Type 2 diabetes mellitus
 * Asthma (moderate-to-severe)
 * Cerebrovascular disease (affects blood vessels and blood supply to the brain)
 * Cystic fibrosis
 * Hypertension or high blood pressure
 * Neurologic conditions, such as dementia
 * Liver disease
 * Pregnancy
 * Pulmonary fibrosis (having damaged or scarred lung tissues)
 * Smoking
 * Thalassemia (a type of blood disorder)
 * Type 1 diabetes mellitus
 * Children who are medically complex, who have neurologic, genetic, metabolic
   conditions, or who have congenital heart disease

Am I at risk?


COVID-19 is very contagious. The risk of getting COVID-19 depends on many
factors, including where you live, recent travel history, and close contact with
people who have symptoms. It is important to comply with any local travel
restrictions and to protect yourself from exposure if you are in a city or area
where the disease is spreading.

How can I protect myself from getting COVID-19?


There are currently no vaccines for COVID-19. The best way to protect yourself
is to avoid situations in which you may be exposed to the virus. Everyday
actions can help protect you and prevent the spread of respiratory diseases such
as COVID-19.

 * Avoid close contact with people who are sick.
 * Avoid touching your eyes, nose, and mouth.
 * Stay home when you are sick.
 * Cover your cough or sneeze with a tissue.
 * Clean and disinfect frequently touched objects and surfaces.
 * Wash your hands often with soap and water for at least 20 seconds.
 * Use an alcohol-based hand sanitizer with at least 60% alcohol if soap and
   water aren’t available. Always wash hands with soap and water if hands are
   visibly dirty.

 

What can I do to prevent spreading COVID-19?


If you test positive for COVID-19 and have mild symptoms, the following steps
can help prevent the disease from spreading to others:

● Stay home
﹣ Stay in a specific room and away from other people in your home
﹣ Restrict any activities outside your home, except for getting medical care
﹣ Avoid public areas, including work and school
﹣ Avoid using public transportation, ride-sharing, or taxis

● Cover your nose and mouth
﹣ If you are sick, wear a facemask when you are around other people or pets
﹣ Cover your mouth and nose with a tissue when you cough or sneeze, and throw
away used tissues

● Wash hands
﹣ Wash your hands often with soap and water for at least 20 seconds
﹣ Wash your hands especially after blowing your nose, coughing, sneezing, going
to the bathroom, or before eating or preparing food
﹣ If soap and water are not available, use an alcohol-based hand sanitizer that
contains at least 60% alcohol
﹣ Avoid touching your eyes, nose, mouth, and other people with unwashed hands

● Do not share
﹣ Do not share dishes, cups, eating utensils, towels, or bedding with other
people or pets
﹣ After using personal items, they should be washed thoroughly with soap and
water

● Clean and disinfect
﹣ Clean high touch surfaces such as counters, tabletops, doorknobs, bathroom
fixtures, toilets, phones, keyboards, tablets, and bedside tables
﹣ Clean any surfaces that may come in contact with body fluids, blood, or stool
﹣ Use a household cleaning spray or wipes
﹣ Immediately remove and wash clothes or bedding that have body fluids, blood,
or stool on them

Is this test FDA-approved or cleared?


No. This test is not yet approved or cleared by the United States FDA. When
there are no FDA-approved or cleared tests available, and other criteria are
met, FDA can make tests available under an emergency access mechanism called an
Emergency Use Authorization (EUA). The EUA for this test is supported by the
Secretary of Health and Human Service’s (HHS’s) declaration that circumstances
exist to justify the emergency use of in vitro diagnostics for the detection
and/or diagnosis of the virus that causes COVID-19. This EUA will remain in
effect (meaning this test can be used) for the duration of the COVID-19
declaration justifying emergency of IVDs, unless it is terminated or revoked by
FDA (after which the test may no longer be used).

What are the approved alternatives?

There are no approved available alternative tests. FDA has issued EUAs for other
tests that can be found at:

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

Is your COVID-19 test reimbursable through my insurance?


While we cannot evaluate all insurance coverage and your insurance carrier
should be contacted for details, the test is reimbursable by most insurance
plans, and this product is covered by participating HSA and FSA plans. An
invoice is provided with every Amazon order and can also be downloaded through
your Amazon order history. You will need to apply for reimbursement directly
with your health insurance carrier and may need to provide the following
information that can be found on both your invoice and test result:

• Patient information
• Ordering physician
• CPT code
• ICD-19
• HCPCS (if Medicare)
• Itemized cost of lab service
• Lab Tax ID#: 20-5016368
• NPI: 1780224659

Submit the itemized receipt through your healthcare insurance provider’s normal
claims submission process. If you have questions about completing that process,
we recommend reaching out to your insurance carrier directly. The American
Medical Association established reimbursement at $100.




COVID-19 FACT SHEETS

FOR PATIENTS
FOR PROVIDERS
CONTACT US

THIS TEST WAS DEVELOPED AND ITS PERFORMANCE CHARACTERISTICS DETERMINED BY
DXTERITY DIAGNOSTICS INC.  DXTERITY HAS ESTABLISHED ITS ACCURACY AND PRECISION
PURSUANT TO THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA-88). 
THIS ASSAY HAS NOT BEEN CLEARED OR APPROVED BY THE US FOOD AND DRUG
ADMINISTRATION.  THE FDA HAS DETERMINED THAT SUCH CLEARANCE AND APPROVAL IS NOT
NECESSARY.  THIS LABORATORY IS REGULATED UNDER THE CLINICAL LABORATORY
IMPROVEMENTS AMENDMENTS 1988 (CLIA-88) AS QUALIFIED TO PERFORM HIGH COMPLEXITY
CLINICAL TESTING. THIS ASSAY IS USED FOR CLINICAL PURPOSES AND SHOULD BE
INTERPRETED IN REFERENCE TO OTHER LABORATORY AND CLINICAL FINDINGS. 

LICENSED, CERTIFIED & ACCREDITED

Maintaining high standards is a core tenet of DxTerity’s commitment to quality.
We maintain a Quality Management System that is ISO 13845 certified.
Our clinical diagnostic laboratory is College of American Pathologists
(CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified
licensed.




FOOTER

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 * GENOMIC TESTING
 * The Need
 * IFN-1 Test
 * SLE Monitoring
 * Modular Immune Profiling
 * Next Gen Sequencing

 * PATIENT PARTICIPANTS
 * Patient Participants
 * Clinical Studies

 * Development Partners
 * Development Partners
 * IVD Product Co-Development
 * Direct To Patient Research
 * Precision Genomic Testing

 * Technology
 * DxReach
 * DxCollect
 * DxDirect
 * Articles

 * ABOUT US
 * Our Story
 * Leadership
 * Careers
 * News & Events
 * Certifications
 * Contact

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Privacy Policy Financial Conflict of Interest Policy
 * Twitter
 * Facebook
 * Linkedin

For Research Use Only. Not for use in diagnostic procedures.
(except as specifically noted). © 2022 DxTerity Diagnostics Inc. All rights
reserved.



 * Robert TerbrueggenCEO and Founder
   Bob Terbrueggen, PhD, has nearly 20 years of experience in the genomics
   industry. He started his career at Clinical Micro Sensors where he was
   Director of R&D and oversaw the development of the world’s first
   bio-electronic DNA detection platform, the e-Sensor. Following the company’s
   acquisition by Motorola, he became the Director of Research for Motorola Life
   Sciences. In 2005, he helped start NanoBiomics, which was named best start-up
   of the year by the Arizona Biotech Association and was subsequently acquired
   by the Molecular Profiling Institute 9 months after founding. Bob is the
   inventor of DxTerity’s DxDirect Technology and the principal Investigator on
   a major US government contract for the development and delivery of the
   REDI-Dx® High Throughput Biodosimetry Test System. Bob double majored in
   Chemistry along with Cellular and Molecular Biology at University of Michigan
   and he received a PhD in Chemistry from the California Institute of
   Technology (Caltech). He is an inventor on 22 issued US patents and more than
   100 associated international patents.

 * James HealyCFO and SVP Business Development, Co-Founder
   Jim Healy, MS, has led operations, business development and finance for
   DxTerity® since 2010. Prior to DxTerity, Jim had 25 years of operations and
   financial leadership in high technology, software and semiconductor
   companies. He started his career at Hughes and rose to be CFO and Director of
   Operations at Hughes Communication Products. His leadership in the advanced
   technology group led to over $250M of new business, including the acquisition
   of Magnavox Radio division. Jim then cofounded JTA Research, a high-speed
   semiconductor company, leading to a successful exit to Cadence Design
   Systems. After acquisition by Cadence and as VP of Business Development, he
   led new product introduction, M&A and supply chain initiatives expanding the
   Electric Design Automation Tools and Test Suite. Jim then took the role of
   CFO and SVP Business Development for Magnify360, an internet advertising
   start-up, where he raised capital and led business development activities for
   onsite behavioral targeting for Intuit, Seagate, ServiceMagic and Autobytel.
   These efforts led to a Top 10 List rating from Frost and Sullivan for
   marketing automation.

 * Aviva JacobsVice President, Product Development
   Aviva Jacobs, PhD, PMP, has over 13 years of experience in the in vitro
   diagnostics industry with Motorola Life Sciences, which was sold to Osmetech
   Molecular Diagnostics and GenMark Diagnostics, where she held multiple roles,
   including Sr. Program Manager, Associate Director of Product Development and
   Director of Product Technical Services. There, she successfully led projects
   and cross-functional teams, resulting in the FDA clearance of genetic tests
   for Warfarin sensitivity, cystic fibrosis, thrombophilia risk and a
   respiratory viral panel on the XT-8 System. From 2011 to 2015, she served as
   the Director of Product Development at DxTerity Diagnostics, overseeing the
   development of a genomic test for radiation exposure, as part of a
   competitive contract funded by the US Department of Health and Human Services
   Biomedical Advanced Research and Development Authority (BARDA). Aviva earned
   a Bachelor of Science in Biology from the University of Michigan, Ann Arbor
   and a PhD in Genetics from George Washington University, in conjunction with
   the National Institutes of Health.

 * Brett SwansigerCCO - Chief Commercial Officer
   Brett has over 20 years of commercial leadership, international business
   development, and managed care contracting experience within the molecular
   diagnostics and pharmaceutical industries. Prior to joining DxTerity, Brett
   held multiple commercial leadership positions at MDxHealth Inc., a
   multi-national urologic oncology company, including VP of Managed Care and
   Payer Strategy, SVP International Business Development & European Sales, and
   SVP of US Sales & Integrated Healthcare Systems. Brett was successful in
   executing licensing and clinical study contracts with diagnostic and
   pharmaceutical market leaders as well as getting key integrated healthcare
   systems like Kaiser Permanente, the Veteran’s Administration, the Department
   of Defense, and Geisinger to adopt new molecular diagnostic testing pathways.
   Prior to joining MDxHealth, Brett was Vice President of Managed Care and Asia
   Market Access for Agendia Inc., and he held multiple commercial leadership
   positions at Prometheus Laboratories Inc., a Nestlé Health Science company
   that focuses on personalized medicine for autoimmune disorders.



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