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MBio is Seeking FDA Approval for LightDeck® Platform

LightDeck® Platform, MBio Diagnostics announced an expanded scope contract with the US Defense Advanced Research Projects Agency (DARPA), where DARPA will apply additional resources and funds to accelerate progress towards FDA approval for MBio’s LightDeck® platform.

MBio has been working with DARPA on a program, “Point-of-care Monitoring of the Host-Pathogen Interaction During Infection,” since February 2018.

The contract enhancement includes an additional $1.5M in funding to allow MBio to augment its clinical and regulatory capabilities, in anticipation of the company seeking first FDA approvals for the platform. FDA approval would significantly expand the applicability of the MBio platform across military and other medical settings.

Under the DARPA funded effort, MBio has been developing human host-response biomarker assays with the goal of identifying gravely ill or highly contagious individuals early in the disease cycle, which may be useful during an infectious disease outbreak as well as standard care in clinical settings.

Michael Lochhead, Ph.D., MBio’s Chief Operating Officer, said, “The current global coronavirus disease (COVID-19) epidemic has created an increased sense of urgency for accurate, rapid, point-of-care testing.  By measuring specific blood biomarkers associated with the human immune response, it may be possible to identify infected individuals early before symptoms emerge to provide guidance to clinicians both on who may spread disease as well as on which individuals may be at greatest risk of developing severe disease.”

Lochhead added, “COVID-19 is showing just how challenging disease management can be when it is spread by people with mild symptoms.  The blood tests we are developing with DARPA will be run on MBio’s portable system, allowing use in small spaces with mobile testing teams.  The tests have the potential to play an important role in quickly identifying the sickest or most infectious patients.  We are grateful for the continued support provided by DARPA.”

Prisma Health Collaborates with Ethicon, Part of Johnson and Johnson Medical Device Companies

Prisma Health announced today that it is collaborating with Ethicon Inc., part of the Johnson & Johnson Medical Devices Companies, to make and distribute a ventilator expansion device, called the VESper™ Ventilator Expansion Splitter.

Prisma Health notes the VESper Ventilator Expansion Splitter is authorized for emergency use only to allow a single ventilator to be fitted with the Ventilator Splitter to be used for two rescuable patients for ventilatory support during the COVID-19 pandemic until individual ventilators are available.

Due to the predicted dire ventilator shortage, Prisma Health received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the device in response to the urgency for more ventilators as a result of the pandemic.

Using 3D printing manufacturing technology, Ethicon will manufacture and distribute the VESper Ventilator Expansion Splitter at no cost to healthcare providers in the United States under the EUA during the current COVID-19 pandemic. The initial distribution of the device will be limited to the United States as Prisma Health and Ethicon are developing strategies to navigate various regulatory pathways and fulfill orders worldwide.

“Our goal is to provide healthcare providers with an emergency use device for critical patients in rapid time at no cost,” said Mark O’Halla, Prisma Health president and chief executive officer. “We are pleased to announce this collaboration with Ethicon which brings nationwide scale and expertise for the manufacturing and distribution of VESper by a top-tier medical device company.”

Prisma Health experts are working with national COVID-19 teams, healthcare providers and state and local health authorities to identify healthcare providers where emergency use of the device is needed and will be working closely with these teams to monitor clinical outcomes. Ethicon is bringing its 3D printing manufacturing and supply chain expertise to meet the challenging demand of providing the ventilator expansion splitters.

Healthcare providers interested in the device should complete the request form on www.PrismaHealth.org/VESper. Prisma Health will review all requests so that the device can be  prioritized to areas and hospitals with the greatest need. The VESper Ventilator Expansion Splitter will be packaged a dozen to a box, two required for each patient in accordance with the Instructions for Use that includes the clinical protocol as published online on March 31, 2020 by the U.S. Department of Health & Human Services Assistant Secretary and the U.S Surgeon General titled “Optimizing Ventilator Use During the COVID-19 Pandemic.” The protocol was included in Appendix D: Ventilator Sharing Protocol: Dual-Patient Ventilation with a Single Mechanical Ventilator for Use during Critical Ventilator Shortage. It is critical that this device be used by only trained healthcare providers with relevant expertise where it is deemed clinically appropriate and necessary and only to address the COVID-19 health emergency.

“This collaboration will allow us to have the highest VESper device consistency for healthcare providers in need of treating COVID-19 patients in the United States and beyond,” said Peter Tilkemeier, M.D., chair, Department of Medicine, Prisma Health–Upstate. “We are providing an option to the medical community, reviewed and authorized by the FDA. Each hospital and community needs to decide the best option for them as they begin experiencing ventilator shortages due to COVID-19.”

“Bringing this device to fruition took a village,” said Marjorie Jenkins, M.D., chief academic officer for Prisma Health–Upstate and dean of the University of South Carolina School of Medicine Greenville. “In addition to our founding team of inventors, collaborators and university partners – Clemson University and the University of South Carolina – our sincere compliments to the many, many industry partners who stepped forward during this public health crisis to support us, including Ethicon; Hewlett-Packard Inc. and its Digital Manufacturing Network; Salesforce; AzimuthDS; the Sargent Foundation; and, the FDA Center for Devices and Radiological Health.”

Halo Labs Closed a $12M Series B1 Financing Round led by Research Corporation Technologies

Halo Labs: The financing round led by Research Corporation Technologies (RCT). In addition, Halo Labs is actively looking at acquiring complementary technologies and companies to expand into the analytical particle space.

Halo Labs reports the Horizon® instrument performs high throughput subvisible particle (SVP) analysis using volumes as low as 25 µL, ensuring samples can be saved for other analyses or for replicates.  It has a 96-well membrane plate that allows several parameters to be tested in a short amount of time without dilution or sample preparation.

“Horizon is crucial at every stage of biologic drug formulation,” said Chad Souvignier, Vice President of RCT. “In early stages, it can reveal SVP formation missed by other techniques such as light obscuration and flow imaging.  In later stages, it can differentiate proteins from extrinsic particles such as glass and plastic. And given the experience of the Halo Labs management team in product development and Sales, we are eager to find other technologies that we can help bring to market.” Additional backers included BroadOak Capital Partners, BioAdvance, top-level industry executive Paul McEwan, and other current employees.

Halo Labs, Robert Wicke, CEO notes, “The success of Horizon, especially in the Gene Therapy field, provides confirmation that next-generation product development is critical. There is so much more this technology can provide in a variety of markets.” Wicke added, “One of our latest customers, the US FDA, will be using the product to help understand the risks for patients on drug product manufacturing. This is a further indication that Horizon is the product of choice for particle analysis in the subvisible range.

Halo Labs serves customers from the drug discovery phase through formulations and bioprocessing, empowering researchers to learn more about the stability and quality of their biological drugs faster and with more accuracy.  Over the years, Halo Labs has been the recipient of many prestigious awards and has received many research grants from agencies including DARPA, FDA, NSF, NIST, and NIH.

iTind Device Receives FDA de Novo Classification Order for Benign Prostatic Hyperplasia: A Non-Surgical Treatment Device

Olympus announced today the FDA de Novo classification of the iTind device, a non-surgical device for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH).

The iTind device was developed by the Israeli-based medical device manufacturer Medi-Tate. Through an investment in Medi-Tate, Olympus holds the exclusive right to distribute Medi-Tate products, including the iTind device, in the U.S. This strategic investment, and the introduction to the U.S. market of this novel device strengthens the already robust Olympus urology portfolio by offering expanded options in enhanced patient care.

BPH is one of the most common diseases in aging men and the most common cause of lower urinary tract symptoms (LUTS).i According to the American Urological Association, BPH is a condition that 8 out of 10 men will face in their lifetimes.ii  Treatment with the iTind device is straight forward and avoids complications associated with prescription medications, surgery, or permanent implants. The flexible three-strut nitinol device, which can be placed during an in-office procedure, gently expands over five days to create channels that allow urine to flow and reshape the prostate.

“Based on my initial experience in clinical trials, I’m excited to be able to offer this new office-based procedure to treat men who are suffering from common symptoms of an enlarged prostate and want a solution that has been shown to not compromise sexual function,” said Dr. Jed Kaminetsky, Clinical Assistant Professor at NYU Medical Center and a Board Certified Urologist at University Urology in New York City.

For years Olympus has been an innovator in developing and marketing surgical treatment options for BPH, with electrodes for resection, vaporization and enucleation. With the recent FDA Classification Order of the iTind device, Olympus will continue to be a global market leader in men’s health.

“We are very excited to take the next step in making this new minimally invasive BPH treatment available to patients in the U.S. and to offer physicians the ability to treat patients in office settings,” said Nacho Abia, COO of Olympus Corporation and CEO of Olympus Corporation of the Americas. “Our investment in Medi-Tate expands our patient care offerings in BPH, adding to our market-leading plasma resection portfolio for TURP. The agreement supports one of the company’s key strategic initiatives to drive growth in our urology business and expand our minimally invasive surgical solutions. This will further enable Olympus to improve clinical outcomes, reduce overall costs and enhance quality of life for patients.”

“After over a decade in development and clinical trials, we are proud to bring this innovative and truly minimally invasive technology to the U.S. market,” said Ido Kilemnik, Founder and CEO of Medi-Tate. “We would like to thank the investors, clinical investigators, FDA de Novo team and all those who have contributed to making this platform such a success.”

References

i Lim KB. Epidemiology of clinical benign prostatic hyperplasia. Asian J Urol. 2017;4(3), 148–151. doi:10.1016/j.ajur.2017.06.004
ii Medical Student Curriculum: Benign Prostatic Hyperplasia (BPH). Auanet.org. https://www.auanet.org/education/auauniversity/medical-student-education/medical-student-curriculum/bph. Published May 2013, Updated July 2016. Accessed March 3, 2020.

US based NEXVOO Announces the Availability of Additional FDA and CE PPE

NEXVOO announces that it is assisting with the US and global pandemic by expanding its resources to offer additional PPE products into the US.

John Gayman, President of NEXVOO®, stated “The current pandemic is causing massive global shortages.  It is humbling to be in a position to help supply these products that are helping to control the spread and transmission of the COVID19 virus and potentially save lives.”

Steven Schmidt, Vice President says, “I’m very proud of the work our team is doing, to assist frontline workers that are in the line of fire. It is inspiring, to see the commitment of Healthcare Leadership and Government Organizations who are working so efficiently in this time of great need.”

To get direct sourcing, please visit https://www.nexvoostore.com. For questions please email the company at  support@nexvooinc.com.

 

Trial for Potential Coronavirus Treatment is Underway at Montefiore and Einstein

Montefiore Health System and Albert Einstein College of Medicine has joined a clinical trial to evaluate the experimental drug remdesivir to treat people who are hospitalized with severe COVID-19 infection.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial. This treatment has the potential to help people who have serious lung complications as a result of COVID-19. Recruitment for the trial began in March and is still underway.

Montefiore-Einstein is one of 46 testing sites nationwide and is the first site in New York Stateto open. NIAID launched the multi-center international effort to determine if remdesivir, a broad-spectrum antiviral drug, acts against COVID-19 viral infection. Remdesivir has shown promise in animal models of severe acute respiratory syndrome (SARS) and Middle Eastrespiratory syndrome (MERS), both caused by human coronaviruses.

The randomized, double-blind, placebo-controlled trial is being led by principal investigator Barry Zingman, M.D., professor of medicine at Einstein and clinical director, infectious diseases, in the Moses division of Montefiore Health System.

The trial is “adaptive,” meaning it can be modified to include other investigational treatments. “This flexibility allows us to add additional therapies to the trial step-by-step to improve treatment as the pandemic continues,” said Dr. Zingman.

Trial participants are hospitalized patients with a laboratory-confirmed coronavirus infection and lung complications, including rattling sounds when breathing, a need for supplemental oxygen, abnormal chest X-rays showing pneumonia, or the need for a mechanical ventilator.

People in the treatment group will receive 200 mg of remdesivir intravenously on the first day of their enrollment in the study and will receive another 100 mg each day for the duration of hospitalization, for up to 10 days total. The placebo group will receive an equal volume of a solution that resembles remdesivir but contains inactive ingredients.

Montefiore and Einstein’s robust clinical trial infrastructure contributed to its selection and rapid approval for participation.

No therapies have yet been approved by the U.S. Food and Drug Administration for treating COVID-19.

Remdesivir, an investigational antiviral therapy, was developed by Gilead Sciences, Inc.

Other clinical trial news of interest can be found here.

 

 

FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19

The FDA continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19. As part of the response to this pandemic, the agency is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood.

These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus. The products can be administered to individuals diagnosed with COVID-19. There are some limited data to suggest that convalescent plasma and hyperimmune globulin may have benefit in the COVID-19 illness. This is why evaluation of these therapies in the context of a clinical trial and expanded access program is so important.

“Under President Trump’s leadership, the FDA is launching a new national effort to bring blood-related therapies for COVID-19 to market as fast as possible,” said HHS Secretary Alex Azar. “The President’s all-of-America approach has driven unprecedented cooperation between the public and private sector, with the FDA finding new ways for the private sector to bring their products to patients while gathering the data we need on efficacy. Thanks to the hard work of FDA staff, scientists and physicians elsewhere, and support from NIH and BARDA, patients will be able to benefit from these promising new options in the coming weeks.”

“This is an important area of research — the use of products made from a recovered patient’s blood to  potentially treat COVID-19 in those affected by this illness. The FDA remains actively engaged with partners across the U.S. government, academia and industry to expedite the development and availability of critical medical products to prevent and treat this novel virus – both evaluating the safety and efficacy of potential therapies and facilitating emergency access for patients, as appropriate,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA had played a key role in organizing a partnership between industry, academic institutions, and government agencies to facilitate expanded access to convalescent plasma. This is certainly a great example of how we can all come together to take swift action to help the American people during a crisis.”

Based on prior experience with respiratory viruses and on data that have emerged from China, these products have the potential to lessen the severity or shorten the length of illness caused by COVID-19. The FDA is facilitating access to convalescent plasma for treating COVID-19 using multiple pathways. The agency’s initial effort was focused on facilitating access to convalescent plasma for the treatment of COVID-19 disease through an emergency investigational new drug application (eIND) process. The FDA has provided information to help health care providers submit these applications to treat individual patients. The agency also is facilitating the conduct of well-controlled clinical trials at academic institutions to rigorously evaluate the safety and efficacy of convalescent plasma.

Notably, the FDA has led an effort, working collaboratively with our industry, academic, and government partners to develop and implement a protocol that will provide convalescent plasma to patients in need across the country who may not have access to institutions with clinical trials in place. This will allow for a simplified process for providers that will help to ensure patient safety, while also allowing for the collection of needed information about product efficacy. In this partnership, the Mayo Clinic will serve as the lead institution for the program and the American Red Cross will help collect plasma and distribute it for use in patients across the country. The program was developed with funding from the Biomedical Advanced Research and Development Authority (BARDA), a component of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary of Preparedness and Response. The FDA anticipates that this collaborative effort will be able to move thousands of units of plasma to the patients who need them in the coming weeks.

The agency is also working with industry and its government partners to accelerate the development and availability of hyperimmune globulin for investigation for the potential treatment COVID-19. Hyperimmune globulin is a biological product manufactured from convalescent plasma. The FDA is helping to coordinate a study of hyperimmune globulin that will be conducted by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, as well as coordinating other efforts in this area.  The FDA continues to provide advice, guidance, and technical assistance to help expedite the development of these products and intends to use regulatory flexibility in making these products and other critical medical countermeasures available to prevent and treat COVID-19.

People who have fully recovered from COVID-19 for at least two weeks are encouraged to consider donating plasma, which could potentially help save the lives of up to four patients. Those willing to donate are urged to visit the American Red Cross website at www.redcrossblood.org/plasma4covid or contact their local blood donor or plasma collection center.

3M Issues Statement in Response to the Announcements Issued by the White House Last Evening

3M, over the last several weeks and months, and its employees have gone above and beyond to manufacture as many N95 respirators as possible for the U.S. market. Yesterday, the Administration formally invoked the Defense Production Act (DPA) to require 3M to prioritize orders from the Federal Emergency Management Agency (FEMA) for our N95 respirators.

3M notes they have been working closely with the Administration to do exactly that, and we appreciate the authorities in the DPA that provide a framework for us to expand even further the work we are doing in response to the global pandemic crisis. We look forward to working with FEMA to implement yesterday’s order.

In the course of our collaboration with the Administration this past weekend, the Administration requested that 3M increase the amount of respirators we currently import from our overseas operations into the U.S. We appreciate the assistance of the Administration to do exactly that. For example, earlier this week, we secured approval from China to export to the U.S. 10 million N95 respirators manufactured by 3M in China.

The Administration also requested that 3M cease exporting respirators that we currently manufacture in the United States to the Canadian and Latin American markets. There are, however, significant humanitarian implications of ceasing respirator supplies to healthcare workers in Canada and Latin America, where we are a critical supplier of respirators. In addition, ceasing all export of respirators produced in the United States would likely cause other countries to retaliate and do the same, as some have already done. If that were to occur, the net number of respirators being made available to the United States would actually decrease. That is the opposite of what we and the Administration, on behalf of the American people, both seek.

We also continue to act on reports of price gouging and unauthorized reselling related to 3M respirators. This activity is unethical and illegal. We are working with the U.S. Attorney General and attorneys general of every state, making it clear that 3M has not and will not raise prices for respirators and offering our assistance in the fight.

We look forward to working closely with the Administration to implement yesterday’s DPA order. We will continue to maximize the amount of respirators we can produce on behalf of U.S. healthcare workers, as we have every single day since this crisis began.

Strict Protocols in Place to Protect the Health of the GM Team Building Ventec’s Critical Care Ventilators in Kokomo

General Motors Co. is actively training employees at the company’s Kokomo plant in the extensive screening, cleaning and other CDC-recommended procedures that will be in place when volume production of Ventec Life Systems’ critical care ventilator begins in less than two weeks. Among the employees is UAW Local 292 member Debbie Hollis of Kokomo. The news was announced today.

Hollis states, “I have family all across the country, so (COVID-19) has impacted everybody that I know and love.” Hollis added, “I’m grateful that I get a chance to do my part and be a part of something…we are modern-day Rosie the Riveters.”

Hollis and the production team, which will grow to more than 1,000 men and women, including people who already work for GM and new hires from the Kokomo area, are also gaining hands-on exposure to Ventec’s ventilator.

“Every ventilator we build can help save lives, and GM’s global supply base and manufacturing teams, the UAW, and the Kokomo community are working with passion and unwavering commitment to getting the job done,” said Gerald Johnson, GM executive vice president, Global Manufacturing. “People have moved mountains to help increase the production of Ventec’s critical care ventilator and we are just weeks away from delivering these lifesaving devices. I have never seen anything like it in my career.”

Kokomo Mayor Tyler Moore said his community is more than ready to do its part, “At this critical moment in our country’s battle against the COVID-19 pandemic, the Kokomo community applauds GM and Ventec leadership for joining the fight by producing much-needed medical ventilators here in their Kokomo facilities. At the same time, they have placed their trust in our community and the incredible Kokomo-area workforce. Kokomo is deeply honored to be a part of this extraordinary endeavor in these extraordinary times.”

Saving Lives and Keeping People Safe
To help protect people working at the Kokomo plant, extensive screening, cleaning, and other CDC-recommended procedures will be in place.

Arrival for Work:

  • Everyone arriving for work will be required to sanitize their hands immediately upon arrival and have their temperature checked with a non-contact thermometer before entering the job site.
  • Everyone will work their shift wearing medical-grade protective masks, including masks produced at GM’s Warren, Michigan facility.

At Work:

  • There will be a 30-minute interval between shifts to allow employees to clean their workstations when they arrive and again before they leave.
  • There will be signage throughout the facility reminding team members to practice social distancing.
  • Each workstation will be manned by one person, and each workstation will be spaced at least six feet apart.
  • Cleaning crews will clean and sanitize common touch surfaces such as door handles, as well as common areas, at least three times per shift.

Between Shifts:

  • Initial production will begin with one shift, with second and third shifts added soon thereafter.
  • Each shift will enter and exit through a different door to minimize social contact.

“The men and women building these ventilators raised their hands to help save the lives of people suffering from COVID-19,” said Dr. Jeffery E. Hess, GM corporate medical director. “We will create a safe workplace using CDC guidelines and scientific data.”

Strong Support from UAW Leadership: The health and safety of every person who enters a GM facility is the top priority for GM and the UAW, especially as people come together to meet the country’s need for ventilators.

“As our nation struggles with the COVID-19 pandemic, volunteer UAW-GM members are doing a tremendous service for our country by volunteering to come to work to make ventilators in Kokomo,” said Terry Dittes, vice president, UAW-GM Department. “For that reason, the UAW has worked with GM to put in place stringent CDC health and safety protocols. Our goal is to make sure that each and every day, people return home to their families and communities safe and healthy. We applaud their courage in volunteering in our nation’s time of need, and we commend GM for working with the UAW to save lives across this country.”

Added Greg Wohlford, UAW Local 292 shop chairperson, “Our members responded to the call for help with courage and a desire to help America save its citizens’ lives. We have pledged, along with GM, to do everything we can to make sure that we keep these everyday heroes safe from illness and injury. The UAW is excited about working with Ventec and GM to produce ventilators in Kokomo, Indiana.”

A Phone Call Sets an Unprecedented Effort into Motion  : The unprecedented teamwork that has allowed ventilator production in Kokomo to move forward so quickly began with a March 17 phone call between General Motors Chairman and CEO Mary Barra and representatives of StopTheSpread.Org, who suggested GM work with Ventec.

StopTheSpread.org was founded by Kenneth Chenault, chairman and managing director at General Catalyst and the former chief executive and chairman of American Express, and Rachel Romer Carlson, the chief executive and co-founder of Guild Education.

  • GM and Ventec executives had their first conference call on Wednesday, March 18 to explore how GM may be able to help Ventec increase ventilator production.
  • The next day, a GM team flew to Seattle to meet with the Ventec team and roll up their sleeves to help.
  • On Friday, March 20, GM engaged its global supply base and within 72 hours, they had developed plans to source 100 percent of the necessary parts.
  • The UAW’s national and local leadership embraced the project and on Wednesday, March 25, crews began preparing the Kokomo site for production.
  • Mass production begins in mid-April. Production will quickly scale up to 10,000 critical care ventilators or more per month.

BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S.A.

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen for COVID-19 (coronavirus) on site and get results in under three hours.

The test helps fill an urgent need across the U.S. for hospitals to access an easy-to-use, rapid diagnostic test to screen patients and health care workers for COVID-19. The test will be run on the BD MAX™ System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. Each unit is capable of analyzing hundreds of samples per day.

“The BioGx molecular test for the BD MAX™ System and our recently announced serology test that can help detect current and past exposure to COVID-19 are part of BD’s approach to give health care workers choice and access to the right test for the right situation,” said Dave Hickey, president of Integrated Diagnostic Solutions for BD. “We continue to work diligently on an antigen test for our point-of-care BD Veritor™ System that would complete a full portfolio of COVID-19 tests.”

The majority of BD MAX™ Systems are installed in hospital laboratories, reducing the added time and complexity of needing to send samples to a reference lab. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. The BD MAX™ System can process 24 samples simultaneously. The tests are expected to add capacity for 50,000 tests per week nationwide.

“The collaboration with BD, combined with the new emergency use authorization process from FDA, enabled our companies to bring a new test to the BD MAX™ System quickly and efficiently,” said Shazi Iqbal, Ph.D., chief executive officer of BioGX. “The development and launch speed was critical to ensure hospitals and laboratories can have additional options and capacity for an automated, highly reliable SARS-CoV-2 test for their patients.”

BioGX developed the assay for the BD MAX™ System in their Sample-Ready™ ready-to-use format to detect the presence of the SARS-CoV-2 virus, the cause of COVID-19. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the U.S. Centers for Disease Control and Prevention (CDC).

Hospitals and laboratories that use a BD MAX™ System can order tests through their BD sales representative.

The BioGX SARS-CoV-2 Reagents for the BD MAX™ System has not been cleared or approved by FDA. However, it has been authorized by the FDA under an EUA. The test has been authorized only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens. The 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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