COVID-19 Testing for Nursing Homes in Massachusetts

Orig3n is offering two options to help meet the testing needs of nursing homes in the Commonwealth of Massachusetts.  

How does the test work?

The Orig3n 2019 Novel Coronavirus (COVID-19) Test is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal, nasopharyngeal, anterior nasal, and mid-turbinate nasal swab specimens from individuals suspected of having the virus that causes COVID-19. Reverse Transcriptase - quantitative Polymerase Chain Reaction (RT-qPCR) is a standard method that is used with most RNA viruses (like HIV, Hepatitis B and C and others). Reverse Transcriptase is an enzyme that ‘reads’ the RNA strand and synthesizes a complementary DNA strand (cDNA). The cDNA can then be detected using a standard qPCR assay.

Testing is limited to the Orig3n, Inc. laboratory located in Boston, MA, which is a Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, certified high-complexity laboratory.

The Orig3n 2019 Novel Coronavirus (COVID-19) Test is intended for use by qualified and trained laboratory personnel specifically instructed and trained in the techniques of real-time PCR assays. The Orig3n 2019 Novel Coronavirus (COVID-19) Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. Please refer to 
FDA’s FAQs on Diagnostic Testing for SARS-CoV-2 for additional information.

Note: Results are for the detection of nucleic acid from SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

How long does it take to get the results?

Results should be available in 24-36 hours after receipt of specimens at Orig3n's CLIA-certified laboratory. Turnaround time is measured as the average number of hours from the date that the specimen is received in Orig3n's laboratory, to when the result is released to the ordering healthcare provider. In some cases, additional time may be necessary.

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This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the  Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 

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Orig3n's laboratory, located in our Boston headquarters, is CLIA-certified by the Centers for Medicare and Medicaid Services. We leverage software and automation to test at volumes that other labs can’t match. Our laboratory processes hundreds of thousands of tests each year, and many thousands each day.

Orig3n office where the CLIA Certified Laboratory used  for  COVID-19  testing  is

ABOUT ORIG3N'S TESTING LABORATORY

Automation machine in Orig3n's CLIA Certified Laboratory helps for scale ofCOVID-19  testing and DNA tests

SCALE WITH AUTOMATION

Interested In Obtaining Tests?

The Orig3n 2019 Novel Coronavirus (COVID-19) Test has earned the FDA’s Emergency Use Authorization (EUA). For more information, please visit: https://orig3n.com/covid19

With the launch of the COVID-19 test, Orig3n embarks on a next phase of growth by entering the clinical diagnostics field. On the foundation  of automation, software, and logistics technologies, we believe that we will be able to evaluate many thousands of patient samples each day in our CLIA-certified high complexity laboratory.  We will continue to stay closely involved in the ongoing response to this pandemic and will endeavor to expand our testing capacity and testing platforms to help address the urgent needs of our country.

CLIA Certified Laboratory used  for  COVID-19  testing and DNA tests
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©2020 Orig3n. All Rights Reserved.

This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the  Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Orig3n DNA Tests are not diagnostic tests and cannot predict your future health. This product including the data, text, images, and graphics, are for informational purposes only. Use of this product is not intended to be a substitute for professional medical judgment and if you have a question about a medical issue please see your doctor.

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FAQs

STEP 1
Sign up. You have the option to use our online checkout method or simply complete the form below on this page.

STEP 2
An Orig3n staff member will call to arrange a date for collection. A member will also reach out to confirm the collection and discuss any last minute details.

STEP 3
The collection team collects the samples, which are then delivered to Orig3n for processing.

Turnkey - How It Works

STEP 4 
The results will be delivered electronically. You'll receive an email once the results are ready.

RESOURCES

If you are interested in obtaining COVID-19 tests, please click the button below for our invoice checkout. To begin the checkout process, we require you to fill out the form found on the following page. Once you submit your form, an Orig3n representative will reach out within 24 hours regarding processing payment and next steps.

Invoice Checkout
  1. Testing service and sample logistics. Should your facility already have the staff and expertise to collect the test specimen, Orig3n will provide the testing service and courier/shipping support to ensure secure transport of samples back to our lab.
  2. Turnkey testing that includes: Orig3n’s COVID-19 testing service, sample logistics as well as on-site collection provided by Orig3n partners. 

$100/person

$130/person

$100/  person

$130/  person