BillionToOne’s unique testing protocol removes costly, time-consuming step of RNA extraction and significantly expands testing capacity

Date of Release: Sept 7, 2020

MENLO PARK, Calif/PRNewswire/ — Today, BillionToOne, Inc., the precision diagnostics company, received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for their groundbreaking SARS-CoV-2 diagnostic test which eliminates the costly and time-consuming step of RNA extraction. As opposed to most other molecular assays that rely on RNA extraction and qRT-PCR, BillionToOne’s qSanger-COVID-19 assay uses a different set of instruments and chemicals from existing tests, therefore enabling labs to unlock a new, unused capacity for the detection of SARS-CoV-2, the virus that causes COVID-19. The test is easily adaptable with minimum training at any laboratories with Sanger Sequencers, which most major clinical laboratories have readily available. 

By utilizing Swift Biosciences’ unique custom manufacturing and distribution expertise, BillionToOne completed the development of its COVID-19 assay kits and began international distribution in May. DASA, the biggest medical diagnostics laboratory in Brazil, has already adopted BillionToOne’s qSanger-COVID-19 assay.

“Since March 2020, we have experienced a severe shortage of RT-PCR consumables, which is seriously restricting our capacity to provide molecular testing in Brazil. The qSanger-COVID-19 allowed us to increase the throughput while using reagents and equipment that do not compete with the RT-PCR needs. The BillionToOne team gave us support during all steps of the implementation and validation,” said Dr. Jose Levi, Head of Innovation in Clinical Analysis at DASA.

“A critical element of combating COVID-19 and enabling communities and economies to reopen is our ability to deliver widespread, cost-effective diagnostic testing across the United States and globally,” said Dr. Oguzhan Atay, CEO of BillionToOne. “With the emergency use authorization of our RNA extraction-free tests, we can now roll out the test in US laboratories in addition to international labs. We’re proud to be on the front lines of the effort to confront the coronavirus pandemic and have now unlocked a cost-effective, scalable way to expand testing in all major laboratories.”

BillionToOne developed the test based on their patent-pending qSanger™ technology. This test adopts the technology behind the Human Genome Project – Sanger sequencing – to the reliable detection of viral RNA. This approach vastly increases testing capacity because a single sequencer can process an average of 4,000 tests per day – 20 times more than qRT-PCR instruments. BillionToOne’s testing method also removes the costly, time-consuming process of RNA extraction, making BillionToOne’s tests more cost-effective, highly scalable, and requiring less manpower to conduct. The removal of the RNA extraction process also removes a critical bottleneck in expanding testing capacity across the United States.

BillionToOne and Swift Biosciences are currently working together with multiple clinical laboratories in the US and around the world to help them adopt the testing protocol. 

About BillionToOne

BillionToOne, headquartered in Menlo Park, California, is a precision diagnostics company with a mission to make molecular diagnostics more accurate, efficient, and accessible for all. The company’s patent-pending QCT molecular counter platform is the only technology platform that can accurately count DNA molecules to the single-count level. BillionToOne’s flagship product, UNITY, is the first and only noninvasive prenatal screening that tests fetal cell-free DNA for cystic fibrosis (CF) and spinal muscular atrophy (SMA) through a single sample of the mother’s blood. BillionToOne was co-founded by Oguzhan Atay, Ph.D., and David Tsao, Ph.D. For more information, visit www.billiontoone.com.

Inquiries:

For any questions regarding partnership and test adoption, please contact covid19@billiontoone.com. 

For any media inquiries, contact media@billiontoone.com

The post FDA grants yet another EUA for RNA Extraction-Free Covid-19 Assay appeared first on Medika Life.

DATE OF RELEASE: Jul 24, 2020, 07:30 ET

GLEN ALLEN, Va. /PRNewswire/ — TCA/ GENETWORx Laboratories announced today that it has added substantial testing capacity and is now providing COVID-19 diagnostic test results in 72 hours or less to help battle the surging coronavirus epidemic. TCA/GENETWORx has performed thousands of COVID-19 tests since March and recently experienced some delays, like most other United States laboratories. In order to supply results in 72 hours or less, TCA/GENETWORx invested millions of dollars in real estate and equipment and has recruited hundreds of employees. TCA/GENETWORx is now one of the only companies in America that can confidently deliver COVID-19 test results within 72 hours from receipt of sample.

In partnership with Nucleus, TCA/GENETWORx has also created a test and sample management program called Aura. By having all patients download Aura, TCA/GENETWORx provides patients and customers including healthcare providers, universities, government, assisted living facilities, nursing homes, and other large population organizations a total end to end digital management and medical data system which provides test locations, test scheduling, sample tracking, symptom tracking, contact tracing assistance, dashboard compliance reporting, and government reporting.

Aura expedites turnaround times, reduces laboratory process time, and allows large population customers, including municipalities, state and federal governments, universities, large corporations, and others to manage the COVID-19 compliance and health of their entire workforce, student, and/or patient population.

TCA/GENETWORx has also developed an end to end program to test large inner-city populations in order to greatly reduce testing inequality. According to Brian O’Neill, Chairman of TCI/GENETWORx, this specialized testing for the inner city is desperately needed, “The age-adjusted COVID-19 death rate for African American people is 3.6 times that for whites, and the age-adjusted death rate for Hispanic/Latino people is 2.5 times that for whites. This is unconscionable and we are offering U.S. cities a managed testing solution to address this problem on a large scale.” 

The company is building capability to perform 870,000 tests per day or 26 million per month. In order to meet demand, the company launched a massive recruiting campaign called Re Employ America and is currently extending offers to 50-100 people per day. Moreover, in the company’s Glen Allen, Virginia laboratory, the TCA/GENETWORx “Families Work Here” program employs multiple generations of families. This has instilled an “all hands on deck” culture at the company which has helped it to grow to meet the demand required by the pandemic.

CEO and Co-Founder of GENETWORx William Miller is a member of one of the multi-generational families working together at Genetworx.

“I’m happy to support the U.S. and Virginia economies through our Re Employ America campaign and I’m proud to have members of my family working side by side with me at TCA/GENETWORx to help battle this pandemic,” said Miller.

Another multi-generational family employed by the company includes twenty-year laboratory testing veteran and Chief Laboratory Officer Sarah Jacobs-Helber. “My daughter and my son work here in the medical technology and operations departments. We all feel a tremendous sense of pride that we are contributing in a very real way in our different job roles at Genetworx as we all work together to perform the vital service of testing hundreds of thousands of Americans during this crisis,” she said.

Miller, who cofounded Genetworx in 2013 with two other scientists added “The heart of our lab is full of national pride and that comes from starting out as a smaller lab whose employees really want to make a difference during the country’s infectious disease crisis.”   

Please visit Genetworx.com for further information on hiring or to order testing. To keep up with the latest news about Genetworx, please follow us on Linked In. For media interviews contact: Terri C.Malenfant at tmalenfant@recoverycoa.com.

The post COVID-19 Testing with 72 Hour or Less Turnaround Time appeared first on Medika Life.