Fluidigm, an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, announced that it has partnered with Healthvana, the nation’s leading patient platform for delivering COVID-19 test results, to provide clinical laboratory customers utilizing the Fluidigm saliva-based Advanta Dx SARS-CoV-2 RT-PCR Assay with the option to deliver test results faster via Healthvana’s mobile platform.

“We are witnessing record-breaking infection rates, and shortening the time for the result to get to the patient is paramount,” said Ramin Bastani, CEO of Healthvana. “On average, after clinical laboratories return COVID-19 test results, we have found that patients view their result within 30 minutes when Healthvana acts as the ‘last mile.’”

Healthvana’s patient-friendly mobile platform delivers test results directly to patients and is tailored to reduce anxiety through easy-to-understand test result information, education and next steps. Patients can access their health information in less than a minute, in multiple languages, and print or download it to show a negative COVID-19 test result before going to school or work or getting on a plane.

Healthvana has partnered with states, local governments, labs, employers and schools to deliver more than 3 million COVID-19 test results since April.

“Since the onset of the global health crisis, companies, universities, governmental entities and others have demonstrated an ability to pivot rapidly and innovate in ways that move us another step closer to effectively managing through this pandemic,” said Chris Linthwaite, President and CEO of Fluidigm.

“This spirit of collaborative problem solving is evident in the patient-focused delivery platform developed by Healthvana, and Fluidigm is pleased to have the opportunity to offer this game-changing tool to our clinical laboratory customers. We believe that Healthvana’s delivery platform and our testing technology will be an extraordinarily effective combination.”

Fluidigm in late August received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus.

The assay does not require collection via invasive nasopharyngeal swab. The company’s clinical study submitted to the FDA demonstrated 100 percent agreement between saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and results from paired nasopharyngeal samples tested with authorized assays.

The Advanta Dx SARS-CoV-2 RT-PCR Assay on the high-throughput Fluidigm Biomark™ HD system features an integrated testing platform and a reliable supply chain that CLIA laboratories can combine with commonly available automation platforms.

Intended Use

Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time Reverse Transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their health care provider. Testing is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and that meet requirements to perform high-complexity tests. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva 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 management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.

Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated. The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Advanta Dx SARS-CoV-2 RT-PCR Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The Advanta Dx SARS-CoV-2 RT-PCR Assay is for In Vitro Diagnostic Use. It is for Use Under Emergency Use Authorization Only. Rx Only. It has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. It has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Other Fluidigm products are For Research Use Only. Not for use in diagnostic procedures.

Source: Company Press Release