Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients
- Immunocompromised transplant patients are at risk of major complications when infected with BK virus
- cobas BKV test addresses critical need for hospitals and laboratories to have standardised and comparable results across institutions
- New Breakthrough Device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK virus with Cytomegalovirus and Epstein-Barr virus
Basel, 8 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) 510k clearance for the cobas® BKV Test on the cobas® 6800 and 8800 Systems. The test was previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients. The test provides standardised, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options.
BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications. Infection can occur without symptoms and happen early in life. After primary infection, the virus can remain inactive, only to possibly reactivate in immunocompromised individuals such as transplant recipients.
“Our diagnostic tests can help clinicians greatly improve patient treatment plans and make quick adjustments for personalised healthcare,” said Thomas Schinecker, CEO Roche Diagnostics. “This FDA clearance allows Roche to offer healthcare professionals a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus and BK virus so they can simultaneously monitor and improve care for transplant patients who are at risk for these common infections or viral reactivations which can cause further illness or death.”
The cobas BKV Test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas® 6800 and cobas® 8800 Systems. Along with the previously approved cobas® EBV and CMV Tests, the cobas BKV Test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international units, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of BKV DNA.
About the cobas BKV Test
The cobas BKV Test was previously granted Breakthrough Device Designation by the FDA, together with the cobas EBV Test.
The cobas BKV Test is a real-time polymerase chain reaction (PCR) test with dual-target technology that provides quantitative accuracy and guards against the risk of sequence variations that may be present in the BK virus. The cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma.
The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making.
The fully automated cobas BKV Test and the cobas CMV and cobas EBV Tests can run on the cobas 6800/8800 Systems simultaneously, providing absolute automation with proven performance and flexibility, leading to time savings and increased efficiency.
About BK polyomavirus
BK polyomavirus (BKV) is a member of the polyomavirus family that can cause transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic stem cell transplantation. Infection can occur early in life, often with no symptoms. After primary infection, the virus can remain inactive throughout life, only to possibly reactivate in immunocompromised individuals, such as patients who receive solid-organ transplants. For kidney transplant patients, BKV infection is considered the most common viral complication, causing polyomavirus nephropathy (PVN) in up to 10 percent of kidney transplant recipients, and about 50 percent of PVN-affected patients will experience transplant graft failure.1 BKV is also associated with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.2
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about three hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift.*
Both systems make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.*
These real-time PCR systems serve the areas of infectious disease, donor screening, sexual health, transplant, respiratory and antimicrobial stewardship.
Through an ever-increasing worldwide install base of cobas 6800/8800 Systems, labs are quickly and easily processing millions of tests per month to meet the changing demands of their communities, their customers, and the patients relying on the results of each assay. Globally, labs know and trust that a Roche assay guarantees high precision, accuracy, and traceability to World Health Organization standards.
Today, rapid advancements in healthcare technology, a shortage of skilled workers, industry-wide consolidation, and the proven need to be ready for the next outbreak have health systems looking to lay a reliable foundation for the future. With proven performance, absolute automation, and unmatched flexibility delivering unparalleled throughput 24/7—cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
Learn more now: www.cobas68008800.com or http://diagnostics.roche.com.
*May vary based on workflow demands
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
 Jamboti, J. S. (2016) BK virus nephropathy in renal transplant recipients. Nephrology, 21: 647– 654. doi: 10.1111/nep.12728.
 Hirsch HH, Randhawa PS; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13528. doi:10.1111/ctr.13528
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: firstname.lastname@example.org
| Dr. Nicolas Dunant|
Phone: +41 61 687 05 17
| Patrick Barth|
Phone: +41 61 688 44 86
| Dr. Daniel Grotzky |
Phone: +41 61 688 31 10
| Karsten Kleine|
Phone: +41 61 682 28 31
| Nina Mählitz|
Phone: +41 79 327 54 74
| Nathalie Meetz|
Phone: +41 61 687 43 05
| Dr. Barbara von Schnurbein|
Phone: +41 61 687 89 67
|Roche Investor Relations|
| Dr. Karl Mahler|
Phone: +41 61 68-78503
| Jon Kaspar Bayard|
Phone: +41 61 68-83894
| Dr. Sabine Borngräber|
Phone: +41 61 68-88027
| Dr. Bruno Eschli|
Phone: +41 61 68-75284
| Dr. Birgit Masjost|
Phone: +41 61 68-84814
| Dr. Gerard Tobin|
Phone: +41 61 68-72942
|Investor Relations North America|
| Loren Kalm|
Phone: +1 650 225 3217
| Dr. Lisa Tuomi|
Phone: +1 650 467 8737
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
ZetaDisplay launches next generation global software platform25.11.2020 08:30:00 CET | Press release
Malmö - ZetaDisplay AB (publ) (Nasdaq Stockholm: ZETA) announces the launch of its next-generation software platform for proprietary, cloud-based content scheduling and distribution. The upgraded ZetaDisplay Engage will be implemented with immediate effect with the Group’s international customer base. “Despite the uncertainty in the market, we have continued to invest in our software and services offer during 2020 to accelerate growth”, says CEO Per Mandorf. “After 5,000 manhours of development we are now ready to launch the latest version of our content management system steering our customers’ Digital Signage networks”, Mandorf continues. The upgrade will happen in two phases where the initial focus will be on a state-of-the-art user interface together with a future-proof cloud-based solution. The platform offers a broad range of functionality, is easily connectable to customers’ digital ecosystem and can also handle live data. In parallel, a new standard service catalogue has been l
ZetaDisplay lanserar nästa generations globala mjukvaruplattform25.11.2020 08:30:00 CET | Pressemelding
Malmö - ZetaDisplay AB (publ) (Nasdaq Stockholm: ZETA) lanserar sin egenutvecklade nästa generations mjukvaruplattform för schemaläggning och distribution av molnbaserat innehåll. Den uppgraderade mjukvaran ZetaDisplay Engage kommer att implementeras med omedelbar verkan hos koncernens internationella kundbas. "Trots osäkerheten på marknaden har vi fortsatt att investera i vårt mjukvaru- och tjänsteerbjudande under 2020 för att accelerera tillväxten", säger VD Per Mandorf. " Efter 5 000 mantimmar av utveckling är vi nu redo att lansera den senaste versionen av vårt content management system som styr våra kunders Digital Signage-installationer", fortsätter Mandorf. Uppgraderingen kommer att ske i två faser där det inledande fokuset kommer att ligga på ett toppmodernt användargränssnitt tillsammans med en framtidssäker molnbaserad lösning. Plattformen erbjuder ett brett utbud av funktionalitet, är lätt att ansluta till kundernas digitala ekosystem och kan även hantera livedata. Parallell
ArcAroma AB: 201125 Samarbetsavtal med OptiFreeze ökar möjligheten till accelerad tillväxt25.11.2020 08:30:00 CET | Pressemelding
Pressmeddelande 2020-11-25 ArcAroma och OptiFreeze har idag tecknat ett utvärderingsavtal gällande samarbete. Syftet med avtalet är att utvärdera möjligheten till framtida gemensamma projekt för livsmedelsapplikationer. ArcAromas organisation kommer dessutom stödja OptiFreeze i deras marknadsexpansion för snittblommor. ArcAroma har under de senaste åren mer och mer fokuserat på livsmedelssektorn. Bolaget ser en stor potential i denna globala marknad och har olika applikationer under marknadsutveckling och nya i utvecklingsfas. ArcAromas ledning och styrelse ser att ett fördjupat samarbete med OptiFreeze erbjuder en stor potential att skapa ett starkare och konkurrenskraftigare ArcAroma inom livsmedelsteknik. Det tekniska och vetenskapliga kunnandet i respektive bolag är komplementära. ArcAroma har redan ett starkt fokus på olika livsmedel och här skulle OptiFreeze gedigna grundforskning och höga kompetens inom metodutveckling kunna bidra till att bredda applikationsportföljen. ArcAroma
Avance Gas Holding Ltd Reports Unaudited Results for the Third Quarter of 202025.11.2020 08:00:00 CET | Press release
BERMUDA, 25 November 2020 – Avance Gas Holding Ltd (OSE: AVANCE) today reported unaudited results for the third quarter 2020. HIGHLIGHTS An achieved time charter equivalent (TCE) rate of $23,283 on a discharge to discharge basis and $21,524/day on the basis of IFRS 15 accounting standard, compared to $28,453/day and $28,932/day in Q2 2020 respectively.The TCE rates in Q3 reflects ballast cost of approx. $4,000/day, corresponding to an adjusted TCE rate of $27,283 in Q3. The ballast cost will recover into the following quarter.Daily operating expenses (OPEX) were $9,256/day, compared to $8,576/day in Q2 2020. OPEX was impacted by change of technical manager and Covid-19 related crew change expense representing approx. $900/day in Q3.A&G expenses were $727/day, up from $608/day in Q2.Secured funding for predelivery CAPEX of newbuilding program through two transactions In September, the sale of the 2003-built VLGC Avance was successfully completed. Following repayment of debt, the transac
Incap Corporation: Incap Group’s Business Review for January–September 2020: Back on track with good growth and profitability25.11.2020 07:30:00 CET | Press release
Incap Corporation Stock Exchange Release Business Review Q3 2020 25 November 2020 at 8.30 a.m. (EET) Incap Group’s Business Review for January–September 2020: Back on track with good growth and profitability July–September 2020 highlights The revenue of the third quarter amounted to EUR 28.1 million, showing an increase of 59.9% (7– 9/2019: EUR 17.6 million).Excluding revenue from AWS Electronics Group acquired in January 2020, the revenue increased organically by 10.7%.Adjusted EBIT was EUR 3.6 million (EUR 2.4 million), corresponding to 12.9% of revenue (13.7%).AWS Electronics Group acquisition related purchase price allocation (PPA) amortisation amounted to EUR 0.4 million (EUR 0.0 million) and non-recurring costs were EUR 0.0 million (EUR 0.2 million). Operating profit (EBIT) was EUR 3.3 million (EUR 2.2 million), an increase of 46.0%, corresponding to 11.6% of revenue (12.7%).Net profit for the period was EUR 2.4 million (EUR 1.8 million), an increase of 33.7%.In November 2020, In
FRO - Third Quarter and Nine Months 2020 Results25.11.2020 07:29:39 CET | Press release
Frontline Ltd. (the “Company” or “Frontline”), today reported unaudited results for the three and nine months ended September 30, 2020: Highlights Net income of $57.1 million, or $0.29 per diluted share for the third quarter of 2020 Adjusted net income of $56.4 million, or $0.29 per diluted share for the third quarter of 2020Reported total operating revenues of $247.4 million for the third quarter of 2020Reported spot TCEs for VLCCs, Suezmax tankers and LR2 tankers in the third quarter of 2020 were $49,200, $25,100 and $12,800 per day, respectivelyFor the fourth quarter of 2020, we estimate spot TCE on a load-to discharge basis of $22,600 contracted for 74% of vessel days for VLCCs, $12,600 contracted for 61% of vessel days for Suezmax tankers and $13,800 contracted for 65% of vessel days for LR2 tankers. We expect the spot TCEs for the full fourth quarter of 2020 to be lower than the TCEs currently contracted, due to the impact of ballast days at the end of the fourth quarter as well