We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

Download Mobile App





Molecular Diagnostic System Aims to Provide PCR Lab in the Palm of Your Hand for Diagnosing COVID-19 in 30 Minutes

By LabMedica International staff writers
Posted on 11 Nov 2021

A new molecular diagnostic system offers a significant advancement in rapid, precise and affordable diagnostic testing for the SARS-CoV-2 virus and is expected to provide results equivalent to lab-based PCR testing in less than 30 minutes. More...

Anavasi Diagnostics (Seattle, WA, USA) has been awarded USD 14.9 million from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative to accelerate the launch and broad market availability of its AscencioDx molecular diagnostic platform for the detection of RNA indicative of the SARS-CoV-2/COVID-19 virus. Previous NIH funding in August 2020 had allowed the Anavasi team to pivot from HIV to COVID-19 detection. The AscencioDx uses sophisticated LAMP (loop-mediated isothermal amplification) molecular diagnostic chemistry and hardware technology to detect HIV viral variants. Now, the same approach is poised to make COVID-19 testing easier and more accurate for everyone.

The AscencioDx offers rapid test results equivalent to lab-based PCR tests, easy and comfortable lower nasal swab sampling procedure, and positive test results in approximately 30 minutes. Its detector is reusable for at least 3,000 single-use COVID-19 tests and its price is comparable to less accurate antigen tests and much lower than lab-based PCR tests. While the initial application of the AscencioDx platform is for the detection of COVID-19, the technology is a perfect platform for the future of bacterial and viral testing.

Currently in clinical trials in the US, Anavasi expects to file its submission to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) in the near future. The initial EUA submission will claim effectiveness for administration by a licensed medical professional in a point-of-care setting, including physician offices, hospital emergency rooms, urgent care clinics, mobile testing sites, colleges and universities, as well as workspaces and other sites deemed appropriate by the healthcare professionals involved.

"At a time when Americans are seeking accurate testing options, our simple system promises to be the new gold standard," said Nelson Patterson, CEO of Anavasi Diagnostics. "It can provide results in approximately 30 minutes comparable to lab-based polymerase chain reaction (PCR) tests. In addition, the AscencioDx platform almost completely eliminates false positives and negatives so frontline health workers no longer need to order multiple tests to ensure an absolute diagnosis. It's a one and done process that's like having a PCR lab in the palm of your hand. We believe that fast, accurate and affordable testing will lead to faster treatment and better healthcare outcomes for patients. We want to save lives."

"The AscencioDx will set a new precedent in rapid affordable, simple-to-complete COVID-19 testing," said Patterson. "When our clinical testing is complete and our submission presented to the FDA, we expect results to demonstrate that no point-of-care test is more accurate. The novel combination of features will make this product unique in the marketplace."

"Future products are expected to include an all-in-one multiplex capability for testing various respiratory diseases at one time, which may ultimately provide impressive accuracy and flexibility, while also saving time and money," Patterson added.

Related Links:
Anavasi Diagnostics 


Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
POC Helicobacter Pylori Test Kit
Hepy Urease Test
New
Gold Member
Immunochromatographic Assay
CRYPTO Cassette
New
Clinical Chemistry System
P780
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Hematology

view channel
Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments

Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read more

Immunology

view channel
Image: The test could streamline clinical decision-making by identifying ideal candidates for immunotherapy upfront (Xiao, Y. et al. Cancer Biology & Medicine July 2025, 20250038)

Blood Test Predicts Immunotherapy Efficacy in Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is an aggressive subtype lacking targeted therapies, making immunotherapy a promising yet unpredictable option. Current biomarkers such as PD-L1 expression or tumor... Read more

Microbiology

view channel
Image: New diagnostics could predict a woman’s risk of a common sexually transmitted infection (Photo courtesy of 123RF)

New Markers Could Predict Risk of Severe Chlamydia Infection

Chlamydia trachomatis is a common sexually transmitted infection that can cause pelvic inflammatory disease, infertility, and other reproductive complications when it spreads to the upper genital tract.... Read more

Technology

view channel
Image: The sensor can help diagnose diabetes and prediabetes on-site in a few minutes using just a breath sample (Photo courtesy of Larry Cheng/Penn State)

Graphene-Based Sensor Uses Breath Sample to Identify Diabetes and Prediabetes in Minutes

About 37 million U.S. adults live with diabetes, and one in five is unaware of their condition. Diagnosing diabetes often requires blood draws or lab visits, which are costly and inconvenient.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.