How Genesis Laboratory Management, LLC is Helping in the Fight Against COVID-19


Genesis Laboratory Management, LLC is proud to offer testing for SARS-CoV-2 (COVID - 19) as well as for the IgG and IgM antibodies to assess immunity to COVID-19 infection. We began offering to test patient COVID-19 samples from local providers and Urgent Care Centers on March 18, 2020. Since then we have tested thousands of patient samples nationwide. As of May 15, 2020 we are now offering antibody testing for clinical use.

We, at Genesis Labs, understand the importance of obtaining these results in a timely manner and pride ourselves on our quick turn-around-time (48-96 hours in the majority of cases) and excellent customer service.

As always, we are available 24 hours a day, seven days a week to provide clinical support to our clinicians ultimately ensuring that you receive incomparable customer service especially in a time like this.

The Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1 Test and/or TaqPath COVID-19 Combo Kit - This assay is for in-vitro diagnostic use under FDA emergency use authorization (EUA). This test is only authorized for the duration of time the declaration should circumstances exist, justifying the EUA under the FDA emergency tests for detection of SARS-CoV-2 RNA virus and/ or diagnosis of COVID-19 infection under section 564(b)(1) of the act, 21U.S.C.360bbb-3(b)(1), unless the authorization is terminated or revoked. The genetic Sites being tested are OFR1, S Protein, and N Protein.

PLEASE NOTE: The Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1 Test and/or TaqPath COVID-19 Combo Kit is indicated as an aid in the diagnosis of specific agents of respiratory illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1 and/or TaqPath COVID-19 Combo Kit. The agent detected may not be the definite cause of this disease.

 
The Panther Fusion® SARS-CoV-2 Assay - This testing method is a real-time RT-PCR in vitro diagnostic test for the qualitative detection of RNA from SARS-CoV-2. SARS-CoV-2 Assay testing is intended for nasal and oropharyngeal (OP) swab specimens obtained for Individuals that meet the clinical and epidemiological criteria for COVID-19 testing. The Panther Fusion® SARS-CoV-2 Assay is for use only under the Emergency Use Authorization (EUA) in the US laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swab 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.

 
FDA Issued EUA to ThermoFisher
Hologic EUA Fact Sheet


SARS-CoV-2 (also known as COVID-19 testing) is available to providers who desire to have their patients tested for the virus and/or antibodies, and COVID-19 related diseases.

During the declared state of emergency, patients with insurance will be billed either (a) if in-network at the network negotiated price, or (b) if out-of-network at the cash price on the labs fee schedule. In either event, so long as required by law, no patient will be balance billed for any co-payment or deductible during the declared state of emergency. If a patient does not have insurance benefits, patient will be entered into the “COVID-19 Uninsured Program”, which is sponsored HRSA and administered through United Health Group. Here again no patient will be billed for any co-payment or deductible. The cash price (charges) for the COVID-19 test is $513.00 for CPT Code 87635/U0004 (after 4-14-20). The cash price (charges) for IgG antibodies is $179.00 for CPT Code 86769 and for IgM antibodies is $119.00 for CPT Code 86769/CS. These cash prices (charges (do not include clinical laboratory tests for other pathogens (such as bacteria and viruses) which may also be ordered as they are COVID-19 related to in to rule out other contributory pathogens. Please click this link for the cash price (charges) of other clinical laboratory tests offered by Genesis.


Our Services

Comprehensive Gastro-Intestinal Solutions


Genesis Laboratory Management, LLC (Genesis Lab) is a state-of-the-art CAP-accredited laboratory providing molecular diagnostic and anatomic pathology solutions for gastrointestinal diseases. From the beginning, our goal has been to advance the current knowledge, fill in the gaps that exist in the diagnosis and treatment of GI diseases, and improve clinical management outcomes.

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Molecular Diagnostics

Solutions for rapid results with high level of sensitivity and specificity.


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Toxicology

Comprehensive drug testing, diagnostic, and therapeutic drug monitoring.


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Pathology

Tests to confirm diagnoses, develop a new medication, and collect tissue samples.


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Cytology and FISH

Advanced cytopathology services for diagnostic and screening testing.


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