Categoría: Geovanny Vicente

WEST HILLS, Calif., Aug. 10, 2020 /PRNewswire/ — Thermo Fisher Scientific continues to expand its response to the COVID-19 pandemic, developing a new serological assay targeted towards transplant candidates and recipients that can detect antibodies directed against COVID-19 (SARS-CoV-2). The assay will be provided under the company’s One Lambda brand representing leading in vitro diagnostic products for the transplant community. This novel antibody detection panel is part of Thermo Fisher’s continued efforts to support transplant patients during the pandemic.

In collaboration with histocompatibility, infectious disease and nephrology laboratories at Emory University, Stanford University, University of Cincinnati and the University Health Network in Toronto, Thermo Fisher’s transplant diagnostic business has developed the LABScreen COVID Plus Assay. The assay leverages the Luminex xMAP technology to detect multiple distinct antibodies and fragments, making it more specific than current assays and able to reduce false positives caused by infections with common coronavirus. In combination with HLA antibody detection, the LABScreen COVID Plus reagents can help provide a more complete picture of a patient’s antibody profile.

The LABScreen COVID Plus Assay will be available for research use only by August 2020.  Additionally, the assay will be submitted for Emergency Use Authorization (EUA).

«We approached Thermo Fisher’s transplant diagnostic business because we believe their expertise with antibody assay development and commitment to the transplant community is critical to develop an assay for transplant patients that could both detect neutralizing antibodies and rule out false positives,» said Dr. Howard Gebel, co-director of the Emory University Hospital HLA laboratory.

«A semi-quantitative multiplex assay that can simultaneously detect the response to spike, receptor-binding domain, nucleocapsid and other SARS-CoV-2 proteins will be a huge step forward towards fully characterizing the immune response to COVID-19,» said Dr. Robert Bray, co-director of the Emory University Hospital HLA laboratory.

«We’re proud of the role we play in responding to the pandemic, and this is one of many examples that demonstrate our ability and our commitment to fight COVID-19,» said Nicole Brockway, president of the transplant diagnostic business for Thermo Fisher. «Transplant patients have unique needs compared to other COVID-19 patients, and with the support of Luminex and our research partners, we’re delivering an innovative solution that’s tailored to meet those needs.»

As the global leader in transplant diagnostics for more than thirty-five years, Thermo Fisher’s transplant diagnostics business is committed to improving the lives of patients worldwide by driving innovation and delivering quality products. The company’s comprehensive product portfolio includes a broad range of antibody detection assays, post-transplant monitoring solutions including the novel Molecular Microscope Diagnostic System, HLA typing products, laboratory instrumentation and software, and industry-leading customer support. 

Laboratories interested in the LABScreen COVID Plus Assay may visit www.onelambda.com for more information.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Media Contact Information:
Charlotte McCormack
Phone: 781-622-1202
Email: charlotte.mccormack@thermofisher.com

 

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SOURCE Thermo Fisher Scientific

WALTHAM, Mass., Aug. 10, 2020 /PRNewswire/ — BVI, the fastest-growing diversified company in ophthalmology, has partnered with Haywood Vocational Opportunities (HVO) to provide isolation gowns to US healthcare workers on the front lines of the pandemic effort.  HVO is a US based medical product manufacturer who provides vocational training and employment opportunities for adults with disadvantages and disabilities.  The partnership took form during the late spring in response to the shortage of Personal Protective Equipment (PPE) caused by the COVID-19 pandemic.  Through outstanding teamwork between the organizations, an isolation gown was designed, tested, manufactured, and ultimately released to the market in less than 3 months which is unprecedented for a company in the ophthalmic industry.  The first recipients of the US-made gowns are healthcare workers throughout North Carolina, where HVO is based.

«As a partner to healthcare service providers, we are very excited to continue our support of front line workers and to support local economies with job creation. I am very proud of the speed at which our two organizations took an idea from concept to final product introduction,» said Shervin Korangy, President and CEO of BVI. 

«COVID-19 cases in North Carolina were increasing rapidly back in April when BVI came to us. We quickly jumped to action and helped jointly develop the isolation gown and started retraining our workforce,» said Audrey S. Gaddis, President of HVO. «We were able to grow our capabilities for our workforce, which was truly a blessing during this surge in unemployment across the country. Thank you to BVI for driving this, HVO is honored to partner with BVI to support our front-line workers.»

About BVI

BVI^® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our organization supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.  Our trusted brands include: Beaver^® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

Learn more at bvimedical.com.

About HVO
Haywood Vocational Opportunities (HVO) is a social enterprise business located in the beautiful blue ridge mountains of Western North Carolina. HVO is the largest manufacturer of custom medical drapes in the US and produces drapes, plus other medical devices for both domestic and international surgical needs.

HVO has more than 35 years of experience in manufacturing disposable healthcare products and has created partnerships with some of the key players in the medical industry. HVO is currently the largest manufacturer of custom medical drapes in the United States.

Learn more at https://www.hvoinc.com/

Media Contact
Lars Bonefeld, VP, Global Marketing, lbonefeld@bvimedical.com

 

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SOURCE BVI

RIDGEFIELD, Conn., Aug. 10, 2020 /PRNewswire/ — Boehringer Ingelheim today announced a new analysis from the GioTag study, which showed that sequential Gilotrif® (afatinib) and osimertinib contributed to a median overall survival (OS) of nearly four years (47.6 months) among U.S. patients (129) with epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) and the common resistance mutation, T790M. These findings are consistent with the global primary analysis of the GioTag study, as well as a separate, interim U.S. analysis.

GioTag is a real-world retrospective, observational study which assessed the impact of first-line treatment with afatinib followed by osimertinib in Del19/L858R EGFR M+ non-small cell lung cancer patients with acquired T790M mutations, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs). This analysis looked at outcomes in the subgroup of patients (129) from the United States. Final analysis for the full GioTag patient population is expected to be published later this quarter.

«Developing resistance to EGFR TKIs is, unfortunately, an expected outcome for many people with this specific lung cancer, and strategies for sequencing treatments continue to evolve with the use of TKIs in clinical practice,» said Balazs Halmos, M.D., Chief of Thoracic/Head and Neck Oncology at Montefiore Medical Center. «These real-world data provide further insight into the overall survival associated with afatinib and subsequent osimertinib treatment and reinforce that previous findings may have application in the U.S. treatment setting for patients with T790M acquired resistance.» 

The afatinib-osimertinib sequence was associated with a combined median time on treatment (time to treatment failure; TTF) of 28.4 months overall. Similar TTF was also observed across several subgroups, including patients with EGFR Del19-positive disease (30.3 months), patients with ECOG PS 0/1 (32.7 months), and in patients ≥65 years of age (34.1 months).

In the most recent analysis, median time on afatinib was 11.3 months (90% CI: 10.3–12.0) and 15.0 months (90% CI: 13.4–16.4) for osimertinib.

Bjoern Rueter, M.D., Therapeutic Area Head Oncology, USA, at Boehringer Ingelheim, said, «These real-world data offer additional evidence that afatinib prior to osimertinib may be an important consideration for patients with EGFR mutation-positive non-small cell lung cancer. Cancer can take away so much, and understanding strategies such as treatment sequencing is one way Boehringer Ingelheim is taking cancer on.»

The U.S. data were sourced from chart review and electronic records of consecutive patients treated at U.S. treatment centers between December 28, 2017, to May 31, 2018. Previous interim analyses published in Future Oncology indicated that sequential afatinib and osimertinib was associated with encouraging time on treatment and overall survival in patients with EGFR T790M-positive NSCLC, particularly in patients with Del19 mutation.

More on the GioTag study can be found here.

What Is Gilotrif?

Gilotrif is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that:

• has certain (non-resistant) abnormal epidermal growth factor receptor (EGFR) gene(s). Your healthcare provider will perform a test to make sure that Gilotrif is right for you.
• has spread to other parts of the body (metastatic), and
• has not been previously treated for metastatic lung cancer

It is not known if Gilotrif is safe and effective in treating people with lung cancer that has resistant abnormal EGFR genes.

or

is used to treat people with squamous cell lung cancer that:

• has spread to other parts of the body, and
• has been previously treated with chemotherapy that contains platinum.

It is not known if Gilotrif is safe and effective in children.

Please see Prescribing Information and Patient Information.

Important Safety Information

Before you take Gilotrif, tell your doctor if you:

• have kidney or liver problems
• have lung or breathing problems other than lung cancer
• have a history of an ulcer, a tear (perforation) in your stomach or intestine, or diverticular disease (inflammation) in parts of your large intestine
• have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
• have heart problems
• have any other medical conditions
• are pregnant or plan to become pregnant. Gilotrif can harm your unborn baby.
• Females who are able to become pregnant should use effective birth control during treatment with Gilotrif and for at least 2 weeks after your last dose of GILOTRIF. Talk to your doctor about birth control methods that may be right for you.
• Tell your doctor right away if you become pregnant or think you are pregnant during treatment with Gilotrif.
• are breastfeeding or plan to breastfeed. It is not known if Gilotrif passes into your breast milk. Do not breastfeed while taking Gilotrif and for 2 weeks after your last dose of Gilotrif. Talk to your doctor about the best way to feed your baby if you take Gilotrif.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Gilotrif may affect the way other medicines work, and other medicines may affect the way Gilotrif works. Taking certain medicines with Gilotrif may increase your risk of developing a tear (perforation) in your stomach or intestine.

What to avoid while taking Gilotrif
Limit your time in the sun. Gilotrif can make your skin sensitive to sunlight. You could get or have worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight during treatment with Gilotrif.

Gilotrif may cause serious side effects, including:

• Diarrhea. Diarrhea is common with Gilotrif and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with Gilotrif, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.
• Skin reactions. Gilotrif can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin, or blisters in your mouth.
• Lung or breathing problems. Gilotrif may cause inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever.
• Liver problems. Gilotrif can cause liver problems that can sometimes lead to death. Tell your doctor right away if you have any symptoms of a liver problem which may include:
• yellowing of your skin or the white part of your eyes (jaundice)
• dark or brown (tea-colored) urine
• pain on the upper right side of your stomach area (abdomen)
• bleeding or bruising more easily than normal
• feeling very tired

Your doctor will do blood tests to check your liver function during your treatment with Gilotrif.

• Tear (perforation) in your stomach or intestine. Tears in your stomach or intestine can happen with Gilotrif and can sometimes lead to death. Your risk of developing a tear in your stomach or intestine may be increased if you:
• take certain medicines with Gilotrif including: corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDS), and certain other medicines.
• have a history of stomach or intestinal ulcers, or if you have had diverticular disease (inflammation in parts of the large intestine)

Get medical help right away if you develop severe stomach-area (abdomen) pain during treatment with Gilotrif.

• Eye problems. Tell your doctor right away if you have symptoms of eye problems. Symptoms may include:
• eye pain, swelling, redness, or tearing
• blurred vision
• sensitivity to light
• other changes in your vision

• Heart problems. Tell your doctor right away if you have any symptoms of a heart problem which may include:
• new or worsening shortness of breath while at rest or with activity
• cough
• tiredness
• swelling of your ankles, feet, or legs
• feeling that your heart is pounding or racing (palpitations)
• sudden weight gain

Your doctor may change your dose, temporarily stop or permanently stop treatment with Gilotrif if you have certain side effects.

The most common side effects of Gilotrif include diarrhea, rash, acne, mouth sores, nail inflammation, dry skin, decreased appetite, nausea, vomiting, and itching.

Gilotrif may cause decreased fertility in females and males. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Gilotrif. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

GF CONS ISI 10.21.19

About Boehringer Ingelheim in Oncology
Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life. In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

Boehringer Ingelheim Pharmaceuticals, Inc.
Communications 
Susan Holz
Phone: 203-798-4265 
Email: susan.holz@boehringer-ingelheim.com

Further Media Channels
www.facebook.com/BoehringerUS
www.twitter.com/boehringerus
www.youtube.com/user/BoehringerUS

 

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

NEW YORK, Aug. 10, 2020 /PRNewswire/ — Knowre Math, which was named the 2020 EdTech Digest EdTech Award Winner for Math Solution and a 2020 SIIA CODiE Finalist for Best Mathematics Instructional Solution for Grades 9-12 & Higher Education, today announced the launch of «Ready? Check. Go!» Ready? Check. Go! aids educators grappling with the difficulties and uncertainties related to COVID-19 learning loss and further Knowre’s mission of enhancing and supporting learning through education technologies to personalize learning for all students.

Knowre Math’s fundamental premise is to discover unique learning gaps in students and to personalize learning to fill those gaps. Ready? Check. Go! supports that endeavor by providing teachers with an accurate picture of a student’s readiness coming into a new school year. Educators are able to immediately deliver Ready? Check. Go! to an entire classroom, and subsequently provide personalized remediation to each individual student. Teachers are also able to see an algorithmically generated readiness scale with actionable insights into student performance.

«As a former teacher, I understand how difficult the beginning of the school year can be for educators,» said Michele Heim, Director of US Content and Curriculum Design at Knowre Math. «COVID-19 and the uncertainties that the pandemic brings to education only amplifies that struggle. Ready? Check. Go! is an easy and helpful way for teachers to start the new year off strong.»

Paul Ward, Director of School District Partnerships, added, «Ready? Check. Go! rounds out Knowre Math’s existing value-add to schools and districts, joining our unique Walk Me Through and algorithmically personalized Targeted 10 assignments to support all students, teachers and administrators.»

Schools and districts can use Knowre Math and Ready? Check. Go! for free for 30-days to effectively personalize learning and cultivate student readiness during the critical back-to-school time period.

About Knowre:
Knowre is an education technology company focused on delivering personalized learning to students around the globe. Knowre’s proprietary artificial intelligence technologies use deep-learning to identify individual student learning gaps, algorithmically generate curricula and deliver interactive, scaffolded support to fill those gaps. The beautifully designed, engaging, and fun digital environment enhances student learning, while educators receive comprehensive and actionable data via the Teacher Dashboard. Knowre partners with schools, private education companies, and other corporations around the world with the goal of helping students reach their full potential.

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SOURCE Knowre

SAN MATEO, Calif., Aug. 10, 2020 /PRNewswire/ — Helix, the leading population genomics company, announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Helix^Ⓡ COVID-19 NGS Test. The test is an amplicon-based next-generation sequencing (NGS) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (nasopharyngeal swabs, oropharyngeal (throat) swab, mid-turbinate nasal swabs, and anterior nasal swabs) from individuals suspected of COVID-19 by their healthcare provider.

This test is highly multiplexed to enable a large number of samples to be sequenced on each instrument and is a critical part of Helix’s plan to scale its COVID-19 capacity to 100,000 tests per day and potentially further. It was developed based on Octant’s «SwabSeq» protocol, which continues to be iterated through a broad community effort involving academic and industry collaborators. As one of the first next-generation sequencing tests authorized by the FDA, the Helix^Ⓡ COVID-19 NGS Test will enable Helix to diversify and add redundancy to its existing supply chain for its PCR-based test, the Helix^Ⓡ COVID-19 Test, also authorized for emergency use by the FDA.

The test will be part of Helix’s end-to-end test system, which includes a non-invasive collection kit, processing of samples in Helix’s CLIA-certified, CAP-accredited high-complexity laboratory in San Diego, next-day turnaround time, and return of results to the ordering healthcare professional, the tested individual, and public health agencies, as necessary.

Helix also announced on July 31, 2020, that it was selected by the NIH’s Rapid Acceleration of Diagnostics (RADx) program to become one of the country’s COVID-19 «mega-labs».

«The authorization of our next-generation sequencing-based test is an important step forward in dramatically scaling our COVID-19 testing capacity while maintaining high sensitivity,» said Marc Stapley, Helix President and CEO. «Combined with the recent funding we announced from the NIH RADx program, we will quickly become one of the highest throughput COVID-19 testing labs in the country and help millions of Americans access much-needed tests with next-day turnaround time.»

«The ability to utilize next-generation sequencing technology to conduct 100,000 tests per day in the same laboratory is a logistical and scientific breakthrough,» said Rick Bright, Ph.D., Senior Advisor to the NIH Director. «This sets the country on an important path in the testing of COVID-19. The NIH’s RADx program is firmly committed to putting its resources and expertise to support the countries’ top innovators to ensure more rapid testing is available to address the COVID-19 pandemic.»

The Helix^Ⓡ COVID-19 NGS Test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This 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.

Additional information, including important test information and limitations, is available at helix.com/COVID.

About Helix

Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world’s largest CLIA / CAP next-generation sequencing labs and its proprietary Exome+® assay, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employers, governments, and other organizations across the country. Learn more at www.helix.com.

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SOURCE Helix