Cepheid variable

DiaCarta, Inc. and OncoAssure Ltd. Collaborate to Launch Prostate Cancer Lab Developed Test

Retrieved on: 
Monday, February 26, 2024

The collaboration aims to leverage DiaCarta's expertise in customizable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure Prostate test.

Key Points: 
  • The collaboration aims to leverage DiaCarta's expertise in customizable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure Prostate test.
  • This partnership will expedite the validation process and pave the way for commercialization of the OncoAssure Prostate LDT test, benefiting healthcare providers and patients alike."
  • Dr. Adam (Aiguo) Zhang, CEO and President of DiaCarta, added, "We are very pleased to collaborate with OncoAssure to bring the best-in-class highly accurate OncoAssure Prostate LDT test to commercialization in DiaCarta's CAP/CLIA laboratory.
  • The unique OncoAssure Prostate prognostic test addresses an unmet need in prostate cancer management and is a valued addition to DiaCarta's portfolio of molecular diagnostic tests for cancer that includes tests for bladder and colorectal cancer."

Danaher Reports Fourth Quarter and Full Year 2023 Results

Retrieved on: 
Tuesday, January 30, 2024

WASHINGTON, Jan. 30, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the fourth quarter and full year 2023.

Key Points: 
  • WASHINGTON, Jan. 30, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the fourth quarter and full year 2023.
  • Non-GAAP core revenue decreased 11.5%, including a 4.5% non-GAAP base business core revenue decline.
  • For the first quarter 2024, the Company anticipates that non-GAAP core revenue will be down high-single digits year-over-year.
  • Danaher will discuss its fourth quarter results and financial guidance for the first quarter and full year 2024 during its quarterly investor conference call today starting at 8:00 a.m.

Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

Retrieved on: 
Thursday, January 18, 2024

SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Key Points: 
  • SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP.
  • This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care.
  • The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.
  • For more information about Cepheid's Xpert Xpress MVP test, please visit Cepheid's website.

The Max Foundation Announces Agreement with Lilly to Provide Access to Verzenio® (abemaciclib) for the Treatment of Advanced Breast Cancer in Kenya

Retrieved on: 
Thursday, January 4, 2024

"We are thrilled to have Lilly join as a Humanitarian PACT partner to expand access to treatment for people living with advanced breast cancer," said Pat Garcia-Gonzalez, Co-founder, and CEO of The Max Foundation.

Key Points: 
  • "We are thrilled to have Lilly join as a Humanitarian PACT partner to expand access to treatment for people living with advanced breast cancer," said Pat Garcia-Gonzalez, Co-founder, and CEO of The Max Foundation.
  • "This donation of Verzenio to help advanced breast cancer patients in Kenya reflects our continued effort to improve access to healthcare for people living in limited-resource settings."
  • Partners in the Humanitarian PACT for ABC have agreed to invest resources and/or their unique knowledge and capabilities to support the expansion of Max Access Solutions to provide access to treatment for HR+/HER2- advanced breast cancer.
  • Late last year, through donation of medicine from Novartis AG, Mozambique became the first country to receive treatment access.

Envista Holdings Corporation Appoints Three New Members to Leadership Team

Retrieved on: 
Thursday, December 14, 2023

Robert Befidi joins Envista from 3M, where he most recently was President of the Separation and Purification Sciences Division, a global filtration technology leader.

Key Points: 
  • Robert Befidi joins Envista from 3M, where he most recently was President of the Separation and Purification Sciences Division, a global filtration technology leader.
  • Suraj Satpathy joins Envista Holdings Corporation from Cepheid, a global diagnostics company under the Danaher Corporation, where he most recently served as the Senior Vice President of Human Resources and Internal Communications.
  • Amir Aghdaei, CEO Envista, is working directly with the Nobel Biocare leadership team to expand the business' capabilities and accelerate growth in 2024 until a permanent successor is named.
  • "Envista and our customers will benefit from the leadership and expertise of Robert, Andrew, and Suraj," said Amir.

Targeted Treatment for Advanced Breast Cancer Including CDK4/6 Inhibitor Therapy Reaches Patients in Mozambique for the First Time

Retrieved on: 
Thursday, November 9, 2023

"This is an important day for women living with advanced breast cancer in Mozambique and beyond.

Key Points: 
  • "This is an important day for women living with advanced breast cancer in Mozambique and beyond.
  • For the first time they will be able to access the latest treatment at no cost," said Pat Garcia-Gonzalez, CEO of The Max Foundation.
  • "Access to adequate diagnosis and treatment is paramount to change the survival and the quality of life of patients with advanced breast cancer.
  • Breast cancer is usually diagnosed at late stages, and due to limited resources, patients may receive inadequate treatment, including supportive and palliative care.

Danaher to Provide Cepheid's Tuberculosis Test to the Global Fund at Cost

Retrieved on: 
Tuesday, September 19, 2023

Enables the Global Fund to provide Cepheid's Xpert® MTB/RIF Ultra diagnostic test cartridges for TB at cost, with no profit to Danaher.

Key Points: 
  • Enables the Global Fund to provide Cepheid's Xpert® MTB/RIF Ultra diagnostic test cartridges for TB at cost, with no profit to Danaher.
  • WASHINGTON, Sept. 19, 2023 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) ("Danaher"), a global science and technology innovator, today announced it will provide Cepheid's Xpert® MTB/RIF Ultra diagnostic test cartridges for tuberculosis (TB) at Cepheid's cost of $7.97 each to the Global Fund to Fight AIDS, TB and Malaria ("the Global Fund") and to less-developed countries eligible for Cepheid's Global Access Program1 to support greater access to high-quality TB testing.
  • By reducing the price of Cepheid's Xpert® MTB/RIF Ultra test cartridge to $7.97, Danaher will be selling at its cost and will earn no profit.
  • The agreement significantly expands a longtime partnership between Cepheid - a Danaher operating company - and the Global Fund to improve access to testing where it matters most.

Market Access and Government Affairs Executive Joins NDA Partners as Expert Consultant

Retrieved on: 
Thursday, September 14, 2023

WASHINGTON, Sept. 14, 2023 /PRNewswire-PRWeb/ -- NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Michele Schoonmaker, a Market Access and Government Affairs executive, has joined the firm as an Expert Consultant. Dr. Schoonmaker is a recognized leader in Market Access and Government Affairs strategy and advocacy with over 25 years of experience driving coordinated, innovative solutions to complex reimbursement, regulatory, and other policy issues to accelerate commercialization of and patient access to state-of-the-art molecular diagnostic tests. She joins the firm to provide strategic solutions to complex market access and/or government affairs problems facing companies or laboratories seeking to bring new diagnostic tests to market.

Key Points: 
  • NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Michele Schoonmaker, a Market Access and Government Affairs executive, has joined the firm as an Expert Consultant.
  • Most recently, Dr. Schoonmaker served as Senior Vice President with Cephid where she built and led the Government Affairs and Market Access function.
  • WASHINGTON, Sept. 14, 2023 /PRNewswire-PRWeb/ -- NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Michele Schoonmaker , a Market Access and Government Affairs executive, has joined the firm as an Expert Consultant.
  • She joins the firm to provide strategic solutions to complex market access and/or government affairs problems facing companies or laboratories seeking to bring new diagnostic tests to market.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Danaher Corporation of Class Action Lawsuit and Upcoming Deadline – DHR

Retrieved on: 
Saturday, September 9, 2023

NEW YORK, Sept. 09, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Danaher Corporation (“Danaher” or the “Company”) (NYSE: DHR), and certain officers.

Key Points: 
  • NEW YORK, Sept. 09, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Danaher Corporation (“Danaher” or the “Company”) (NYSE: DHR), and certain officers.
  • To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

DANAHER DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Danaher Corporation and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, September 14, 2023

Investors have until September 15, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until September 15, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Danaher designs, manufactures, and markets professional, medical, industrial, and commercial products and services worldwide.
  • The Company is comprised of more than 20 operating companies organized under four segments: Biotechnology; Life Sciences; Diagnostics; and Environmental & Applied Solutions.
  • On April 25, 2023, Danaher issued a press release announcing its financial results for the first quarter of 2023.