BioMedomics receives Health Canada authorization for its CoV-SCAN Rapid Antigen Test

Morrisville, NC, USA – BioMedomics, a renowned player in the medical diagnostics field, has recently received authorization from Health Canada’s Medical Device Directorate to import and distribute its CoV-SCAN Rapid Antigen Test and the COVID-19 Antigen External Control Kit. This significant achievement underscores the accuracy and reliability of BioMedomics’ test kit in detecting the presence of COVID-19.

The CoV-SCAN Rapid Antigen Test is a result of collaboration between BioMedomics and a major academic medical institution in the United States. The kit employs a panel of antibodies that allows it to detect various variant viruses, including Omicron and its many subtypes, from human specimens. BioMedomics’ test kit stands out from existing approved rapid antigen tests due to its incorporation of novel antibody technologies licensed from a world-leading group on COVID-19 at a major US academic institution. Specifically, the kit uses multidomain antibodies, which originally derived from human COVID-19 patients’ antibody selections, and is uniquely designed to detect all existing COVID variants and any future emerging variants.

In a clinical trial, the CoV-SCAN demonstrated a sensitivity of 95% in specimens with CT values less than or equal to 30 and a specificity of 100%. Furthermore, the test detected most specimens with CT values greater than 30, with an average value of 35.3. The CoV-SCAN is designed for professional use and can be used with anterior nasal swab specimens collected from individuals who are symptomatic within five days of symptoms, ages 2 years and older. The kit provides results in just 15 minutes. The COVID-19 Antigen External Control Kit, designed specifically for the CoV-SCAN, is available for purchase separately from BioMedomics.

“We are thrilled to have received Health Canada’s authorization for the CoV-SCAN Rapid Antigen Test and the COVID-19 Antigen External Control Kit,” said Dr. Frank Wang, CEO of BioMedomics. “This approval is a testament to the hard work and dedication of our team working with our great partner in developing a reliable and accurate test kit that can be used by healthcare professionals in the fight against COVID-19.”

The CoV-SCAN Rapid Antigen Test is now available for use in Canada through authorized channels. To purchase the kit or obtain more information about it, visit the BioMedomics website and contact the company’s sales team.

Saudi FDA Approval Announcement

BioMedomics is an ISO 13485 certified company committed to meeting unmet market needs by developing innovative point-of-care diagnostic tests which provide immediate answers to individuals and their healthcare providers.

Saudi FDA approval

SARS-CoV-2 Antigen Test Kit (LFIA) 

CE approved SARS-CoV-2 Antigen Test is a lateral flow immunoassay (LFIA) that detects the most abundant protein (NP) antigen of SARS-CoV-2 and its various mutations of concern in 15-20 minutes using a double-antibody sandwich assay.

COVID-19 IgM-IgG Antibody Rapid Test

CE approved, rapid, point-of-care COVID-19 IgM-IgG Antibody Rapid Test is one of the world’s most sensitive tests for COVID-19 delivers results in 10 minutes. It detects both early (IgM) and late (IgG) marker antibodies in human finger-prick capillary blood, venous whole blood, serum, and plasma.

BioMedomics CoV-SCAN Rapid Antigen Test demonstrated high sensitivity and specificity for numerous SARS-CoV-2 variants, including Omicron and Delta, in a peer-reviewed point-of-care clinical evaluation

BioMedomics CoV-SCAN Rapid Antigen Test demonstrated high sensitivity and specificity for numerous SARS-CoV-2 variants, including Omicron and Delta, in a peer-reviewed point-of-care clinical evaluation

Recently published in the highly regarded, peer-reviewed Journal of Clinical Virology Plus, a clinical point-of-care and laboratory trial, performed in conjunction with the Columbia University Irving Medical School, demonstrated the ability of the BioMedomics CoV-SCAN Rapid Antigen Test to detect SARS-CoV-2 variants with high sensitivity and specificity. These results are due to CoV-SCAN’s unique design, using 4 unique antibodies to detect SARS-CoV-2.

In laboratory testing, CoV-SCAN detected 14 variants, including Omicron and Delta, with similar sensitivity to the wild-type virus; CoV-SCAN did not cross-react with any other human coronaviruses.

In clinical point-of-care (POC) testing on 148 individuals over age 2 with symptom onset of less than or equal to 5 days, CoV-SCAN detected SARS-CoV-2 in 87.2% of COVID-19 infected individuals and did not misdiagnose any non-infected individuals. In another 884 asymptomatic individuals, CoV-SCAN detected 85.7% of COVID-19 infected individuals and correctly diagnosed 99.7% of non-infected individuals.

Importantly, CoV-SCAN detected SARS-CoV-2 in greater than 97.2% of patient specimens with CT values < 30, a well-established clinically meaningful cutoff for infectivity.

These results demonstrate that CoV-SCAN should detect SARS-CoV-2 variants, known and unknown, in almost all individuals harboring infectious quantities of COVID-19. Additionally, CoV-SCAN’s high specificity makes it incredibly useful for the early identification of new infectious clusters before they become hotspots.

To read the full article please click here

BioMedomics COVID-19 IgG/IgM Rapid Test highly effective in point of care (POC) use

The BioMedomics COVID-19 IgG/IgM Rapid Test is a rapid, point-of-care (POC) lateral flow immunoassay (LFA) that detects antibodies to the SARS-CoV-2 spike protein receptor-binding domain (RBD). It detects both early (IgM) and late (IgG) marker antibodies in human finger-prick capillary blood, venous whole blood, serum, and plasma. Since its launch in March 2020, it has gone through several independent validations and is being used globally in hospitals, clinics, and government agencies.

Widespread deployment of POC testing for SARS-CoV-2 could transform the global COVID-19 response, helping individuals quickly understand whether they were previously infected or have developed a robust response to vaccination, and informing health officials on the level of community protection that may be present.

As their use extends beyond traditional clinical settings to help determine serostatus after infection or vaccination, evaluating test performance against laboratory assays at the POC, not just in controlled laboratory settings, is essential.

A recent study provides insight into how SARS-CoV-2 lateral flow assays are likely to perform in POC settings when used by individuals other than laboratory professionals.

When used 1 month after the onset of symptoms, the demonstrated robust sensitivity (90%) and complete specificity (100%) in a heavily exposed household cohort.

To read the full article please click here

BioMedomics Celebrates Sickle Cell Awareness Month

September is National Sickle Cell Awareness Month. Sickle cell disease is an inherited disease that distorts soft and round red blood cells and turns them into hard, crescent shaped cells. These distorted red blood cells can cause those affected to experience extreme pain and often requires numerous blood transfusions to increase the number of normal red blood cells in the body and unblock blood vessels. According to the American Red Cross, a patient with sickle cell disease may need up to 100 units of blood each year to treat complications from the disease.

BioMedomics would like to reaffirm our commitment to improving the quality of life and health outcomes of those affected by sickle cell disease. We encourage everyone to be part of this international effort to increase awareness about sickle cell disease and sickle cell trait. Individuals and organizations can join our efforts by donating blood, engaging elected officials for proclamations, and distributing educational information to dispel the myths about sickle cell disease.

BioMedomics™ Sickle SCAN® is a multiplexed, qualitative, point-of-care immunoassay to aid in the rapid diagnosis of sickle cell disorders. The test is made up of three indicators which detect the presence of hemoglobin A, S, and C, allowing the user to rapidly distinguish between normal, carrier, and sickle cell disease samples.

  • No electricity or instrumentation required
  • Combined sensitivity and specificity of >99%
  • Results in 5 minutes
  • Suitable for newborn screening
  • Ships worldwide

For more information, please email info@biomedomics.com. To place an order, please email sales@biomedomics.com.

BioMedomics, Inc. Recertified for ISO 13485

BioMedomics, Inc. is proud to announce that the BSI Group of America has accredited and recertified our ISO 13485:2016 certification.

The certification of compliance with ISO 13485:2016 recognizes that the policies, practices and procedures of our company ensure consistent quality in the product and services we provide our clients. With this certification, our clients can be confident that BioMedomics, Inc. is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – guaranteed client satisfaction.

BioMedomics, Inc. is certified as meeting the requirements of ISO 13485:2016 for the following activities:

The design, development and manufacture of in-vitro diagnostic medical devices used in the detection of hemoglobin disorders and/or adaptive immune responses including laboratory and point-of-care in-vitro diagnostic medical devices.

To maintain our certification, we will perform audits to ensure compliance and to assess initiatives for continued improvement. Our clients can be confident that BioMedomics, Inc. will continue to provide the high-quality products and services they have come to expect well into the future.

Article about BioMedomics’s COVID-19 IgM/IgG Rapid Antibody Test Awarded as Top Cited Paper in Journal of Medical Virology!

An article about BioMedomics’s COVID-19 IgM/IgG Rapid Antibody Test that several employees of BioMedomics, Inc., worked on has been awarded as one of the top cited papers 2019-2020 by the Journal of Medical Virology!

The Journal of Medical Virology is a peer-reviewed medical journal covering fundamental and applied research in regard to viruses that effect humans.

Congratulations to our team members for their contribution towards educating the public on the importance and effectiveness of COVID-19 antibody tests! To read the article, click here.

 

 

BioMedomics, Inc.’s ISO 13485 Certification Granted Expansion

BioMedomics, Inc. is proud to announce its ISO 13485:2016 certificate has expanded in scope to include the design, development and manufacturing of COVID-19 rapid tests.  The certification is accredited by BSI Group America.

The certification of compliance with ISO 13485:2016 recognizes that the policies, practices and procedures of our company ensure consistent quality in the product and services we provide our clients. With this certification, our clients can be confident that BioMedomics, Inc. is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – guaranteed client satisfaction.

BioMedomics, Inc. is certified as meeting the requirements of ISO 13485:2016 for the following activities:

The design, development and manufacture of in-vitro diagnostic medical devices used in the detection of hemoglobin disorders and/or adaptive immune responses including laboratory and point-of-care in-vitro diagnostic medical devices.

To maintain our certification, we will perform audits to ensure compliance and to assess initiatives for continued improvement. Our clients can be confident that BioMedomics, Inc. will continue to provide the high-quality products and services they have come to expect well into the future.

We believe that our decision to expand our ISO certification to include our COVID-19 product line is a proactive one that not only anticipates the demands of our clients, but also demonstrates our commitment to providing quality services to all our clients.

COVID-19 IgM/IgG Rapid Test Approved by INVIMA in Colombia!

We are excited to announce that the National Institute for Food and Drug Surveillance (INVIMA) has given BioMedomics, Inc. authorization to sell and distribute our COVID-19 IgM/IgG Rapid Test in Colombia!

We have partnered with Piso Pélvico-GILMEDICA S.A. to assist with distributing our product to customers. For sales requests in Colombia, please contact Mr. Julián Potes by email (julian.potes@gilmedica.com) or phone (+57 318 827 49 94).

BioMedomics’s COVID-19 IgM/IgG Rapid Test is one of the first and most accurate COVID-19 antibody rapid tests on the market, winning over competitor testing methods with:

  • Fastest test result of 10-15 minutes
  • Highest combined sensitivity/specificity (100%/~99%)
  • Intuitive visual interpretation
  • No special equipment needed

For information or questions about our COVID-19 IgM/IgG Rapid Test, please email info@biomedomics.com

To receive a quote and place an order, please email sales@biomedomics.com

*Not available for sale within the USA.