The Aptima® and Panther Fusion® assays help guide . Molecular Testing | Lab Automation | Scalable Growth| Hologic Hologic's financial guidance for the fourth quarter of fiscal 2021 is shown in the table below. Hologic deals stake in Procleix blood-screening biz to ... Analytical and Clinical Performance of the Hologic Aptima ... Evaluate cell pellet. . The first FDA-approved direct test to help diagnose smear-positive and smear-negative specimens, the Amplified . †. Zika Blood Screening Test From Hologic, Grifols Gets FDA ... Ease the strain of pre-analytical sample processing in your lab and re-deploy your staff for more value added tasks by adding the Tomcat instrument to your lab.A fully automated general purpose instrument, Tomcat is designed to eliminate the inefficient and error-prone process of manual aliquoting. Fix, stain, and evaluate for cytology OR perform molecular testing Blood & Plasma Screening Products for Nucleic Acid Testing ... Be-cause results of quality-control testing were consis- Tests are priced individually. To focus more on its core business, Hologic, Inc. HOLX recently inked a deal to divest its stake in the blood screening business. Prepare slide on ThinPrep® 2000 using Sequence 5 or ThinPrep 5000 using Sequence UroCyte® 9. 10 ThinPrep Pap tests account for more than 80% of Pap tests . TMA is the same technology that delivers the high standards of specificity for blood screening products.. TMA utilizes biochemical reactions, rather than mechanical thermocycling, to drive amplification. These preliminary results compare to the Company . Hologic, Grifols close $2B Procleix blood-screening biz ... Hologic reported Q4 diagnostics revenues of $836.8 million, down 11%. Heart Disease Prevention Findings | Hologic | Drush Site ... Hologic Completes Divestiture of Blood Screening Business ... Grifols already owns all the customer-facing parts of the business; it will now take on research, development and manufacture of assays and instruments based on nucleic acid testing for transfusion and transplantation screening. PDF Investor Relations | Hologic Aptima HIV-1 Quant Dx Assay | FDA Interestingly, Hologic's competitor in the blood screening market, Roche, received IND for a Zika assay for blood screening in Mar 2016, indicating the gradual emergence of Zika virus tests in the . 10 stocks we like better than Hologic. Blood banks use Hologic's automated Tigris and Panther systems to run molecular assays and screen donated blood for viruses including HIV, hepatitis C and B, West Nile, and Zika. When o ur award-winning analyst team has a stock tip, . Add recommended # of drops of specimen to PreservCyt® Solution Vial and allow to stand for 15 minutes 8. The business will be going to Hologic's longstanding . In 2016, Hologic, Inc and Grifols, S.A being in a partnership agreement, received the US Food and Drug Administration (FDA) approval for its Procleix Zika virus blood screening assay. The Procleix Zika test is one of a suite of nucleic acid technology products developed under the Hologic-Grifols partnership, used in screening blood for HIV, hepatitis, West Nile virus and other . The acquisition has been structured through Grifols Diagnostic Solutions, a U.S. incorporated, wholly-owned subsidiary of Grifols, S.A. Aptima HIV-1 Quant Dx Assay is an in vitro nucleic acid amplification test (NAAT) for the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected . In addition to HPV, other STIs can be tested from the same Thin Prep vial. For more information on Hologic, visit . Hologic's blood-screening business was expected to contribute $240 million in sales and 34 cents earnings per share ex items in 2017. "As we wrap up Hologic's best financial year in our fourth fiscal quarter, we expect strong growth in our base businesses, offset by declines in COVID testing revenue," said Karleen Oberton, Hologic's chief financial officer. The ThinPrep Pap test: First in liquid-based cytology . The . Serological testing is defined as an analysis of blood serum or plasma and has been operationally expanded to include testing of saliva, sputum, and other biological fluids for the presence of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies. . The screening effort is . Interestingly, Hologic's competitor in the blood screening market, Roche, received IND for a Zika assay for blood screening in Mar 2016, indicating the gradual emergence of Zika virus tests in the . The company's Procleix Zika Virus Assay is designed to detect for up to seven days the presence of ribonucleic acid linked to the mosquito-borne virus in the blood supply, HHS said Tuesday. In September, Hologic announced that its CE-marked Aptima HIV-1 Quant Dx assay has been awarded World Health Organization prequalification for testing of dried blood spot samples. ty-control testing by singleplex NAAT (13,14) on all ZIKV-positive specimens. Published: Jan 09, 2022. December 14, 2016 (NEW YORK) - International law firm Proskauer represented longtime Barcelona-based client Grifols (NASDAQ: GRFS) in its $1.85 billion definitive agreement to acquire the blood screening business of its commercial partner Hologic. Innovation That Empowers. - Strengthens Efforts to Build a Sustainable Growth Company - Accelerates Top- and Bottom-Line Growth Rates, Increases Financial Flexibility - MARLBOROUGH, Mass. , Jan. 31, 2017 / PRNewswire / - Hologic, Inc. (Nasdaq: HOLX) has completed the divestiture of its blood screening business to long-time commercial partner, Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS) for a purchase price of $1.85 . Procleix, the zika screening test from Hologic and a partner company, has been used by the American Red Cross to screen blood for HIV and hepatitis B and C. Search World Hologic has been responsible for R&D of Procleix blood screening products, and Grifols has been responsible for global commercialization. The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response has announced a $4.1 million agreement with Hologic, Inc. of Marlborough, Massachusetts, to advance the development of a blood screening test that will help detect the presence of Zika in the blood supply. Hologic's Selenia Dimensions breast tomosythesis cancer screening system—featuring the company's Genius 3D Mammography exam—was approved by the U.S. Food and Drug Administration (FDA) in 2011. The IND study will use the . 2002 FDA approves the first nucleic acid test for screening donated blood prior to transfusion. --Blood banks will use the new test, co-developed by Hologic and Grifols, to screen donated blood in potential endemic areas of the US-- . Amplification of both targets results in a presumptive positive (detectable) test result, while amplification of one of two targets results in an inconclusive result, and amplification of neither . cervical cancer screening1 Aptima HPV Assay The Aptima® HPV assay is the first FDA-approved test for HPV mRNA, and the test detects mRNA from 14 high-risk HPV types associated with cervical cancer.1 The Aptima HPV assay can be used together with the Pap for women age 30 and older, as well as for reflex on ASC-US Pap results.1 Hologic, Inc. (Nasdaq: HOLX) announced today preliminary revenue results for its first fiscal quarter ended December 25, 2021. Hologic has received a one-year, $4.1 million contract from the Department of Health and Human Services to further develop a test that works to detect Zika virus in donated blood.. To focus more on its core business, Hologic, Inc. (HOLX Quick Quote HOLX - Free Report) recently inked a deal to divest its stake in the blood screening business.Per the terms of the agreement . Hologic's Molecular Test for the Novel Coronavirus, SARS-CoV-2, Receives FDA . Grifols, Barcelona, Spain, has entered into an agreement to acquire the blood donor nucleic acid screening unit of Hologic, Bedford, Mass, for $1.85 million. The deal is slated to close . Please request tests individually. Adding Tomcat to your lab can help to: • Conflict of interest: the presenter is an employee and stockholder of Hologic Inc., which develops and manufactures NAT blood screening assays in partnership with Grifols Grifols is buying Hologic's interest in their existing joint blood screening unit for $1.85 billion. We expect blood screening revenue of $5 million to $6 million in Q1, and $20 million to $25 million . One of the state's biggest health care companies, Hologic, expects to use the proceeds from the $1.85 billion sale of its blood screening business based in San Diego for small acquisitions, to . Hologic, Inc., entered into an agreement on Tuesday worth $4.1 million with the U.S. Department of Health and Human Services' (HHS) Office of the Assistance Secretary for Preparedness and Response (ASPR) to advance the development of a blood screening test that will detect Zika virus. Revenue of $1,471.1 Million Significantly Exceeds Guidance. To assist with "apples to apples" analyses of Hologic's ongoing, base business, the historical contributions of blood screening to Hologic's quarterly revenues and EPS are shown below: GAAP 2017 2018 Q1 Q2 Q3 Q4 Total Q1 Q2 Revenue $65.2 $38.3 $19.0 $18.0 $140.5 $12.6 $11.3 The U.S. Food and Drug Administration has given the go-ahead for a trial to use an assay from Hologic and Grifols to test the U.S. blood supply for the Zika virus. Spain's Grifols SA, which develops plasma protein therapies, said it would buy U.S. medical device maker Hologic Inc's interest in their blood screening joint venture for $1.85 billion in cash. This fully automated platform provides test consolidation, random-access sample loading and proven assay chemistry to deliver high performance and results you can trust. If pellet is not free of blood, do a CytoLyt wash 7. The Tigris DTS (direct tube sampling) system automates all phases of molecular diagnostics testing — from sample preparation, amplification and detection to reporting results — giving laboratories better, faster and more efficient ways to work. Hologic Inc. is slated to sell its profitable blood screening business, which accounted for almost 20 percent of the Marlborough, Mass. * Hologic to divest blood screening business to partner Grifols for $1.85 billion Source text for Eikon: Further company coverage: Our Standards: The Thomson Reuters Trust Principles. Hologic is a global champion of women's health, we integrate The Science of Sure into everything we do to help improve and save lives through early detection and proactive treatment. Hologic said its share of the blood-screening business was forecast to put up adjusted earnings of 34¢ per share on sales of roughly $240 million in fiscal 2017. 2 Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. Hologic, has completed the divestiture of its blood screening business to long-time commercial partner, Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS) for a purchase price of $1.85 billion in cash, the Company announced. Requests for additional tests from the vial already received in the laboratory can be made by contacting the Cytology Department. Powerful and versatile blood and plasma screening solutions to meet your testing needs, with a portfolio of high-quality products, state-of-the-art technology, and expert support. Hologic (NSDQ:HOLX) said today that it closed the sale of its stake in the Procleix blood-screening business it runs with Grifols (NSDQ:GRFS) for nearly $1.9 billion. This transaction is part of the consolidat. 1 Today, more than 20 years after the release of the ThinPrep Pap test, it remains the preferred choice in Pap testing in the United States. 1 The first Hologic Global Women's Health Index reveals a significant gap between the need for blood pressure screening to catch early signs of heart disease and the availability of screening around the world. Hologic subsequently acquired Gen-Probe in 2012 for $3.7 billion, and the blood screening partnership with Novartis remained intact. MARLBOROUGH, Mass., Dec. 14, 2016 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) has entered into a definitive agreement to sell its share of its blood screening business to long-time commercial partner, Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), for gross proceeds of $1.85 billion in cash, the Company announced today. Hologic and Grifols are the global leader in molecular blood screening, and have collaborated since 1998 through their respective predecessor companies. Featuring ART. In the collaboration, Hologic is primarily responsible for research and development and manufacturing of the Procleix blood screening products, while Grifols is responsible for commercialization It is the first system to offer absolute automation for molecular diagnostics with unmatched versatility and ultimate flexibility. This is second blood -screening test which Health and Human Services is helping advance to test donated blood for Zika. Hologic is also witnessing a decline in its COVID-19 testing revenues following the vaccine rollout.Estimate TrendOver the past 60 days, the Zacks Consensus Estimate for Hologic's fiscal 2022 . The Aptima HIV-1 Quant Dx assay uses proprietary technology from Hologic —real-time transcription mediated amplification (TMA)—to offer excellent sensitivity and specificity. Hologic Inc. HOLX, +2.32% rallied in Wednesday's extended session after the company said it plans to sell its stake in a blood screening business to Grifols for $1.85 billion in cash. Since then, the technology has begun to draw attention with celebrity spokeswomen to sing its praises, as well as generate awareness for the . Hologic ,Blood Screening,Grifols ,Zika Virus,blood screening business Hologic, Inc. has entered into a definitive agreement to sell its share of its blood screening business to long-time commercial partner, Grifols, for gross proceeds of $1.85 billion in cash Moody's: Hologic's blood screening divestiture is credit positive 14 Dec 2016 New York, December 14, 2016 -- Moody's Investors Service today commented that the proposed divestiture of Hologic's blood screening business to Grifols SA for $1.85 billion is credit positive. Hologic's partner in the blood-screening business, Grifols SA, will buy-out Hologic's share for $1.85bn. company's diagnostic revenues in fiscal 2016. The agreement encompasses research, development, and manufacture of assays and instruments using nucleic acid technology for the detection of infectious agents in blood and plasma . The transaction has been approved by the boards of directors of both . In 2016, F. Hoffmann-La Roche Ltd, received US Food and Drug Administration (FDA) approval for its cobas MPX test applicable with analyzers like cobas 6800 and . Objectives: To compare the analytical performance of the Aptima HCV Quant Dx Assay (Aptima) and the COBAS Ampliprep/COBAS TaqMan HCV Test v2.0 (CAPCTMv2 . Hologic released the first FDA-approved, liquid-based cytology option in cervical disease screening in 1996: the ThinPrep Pap test. Hologic and Grifols' alliance on molecular blood screening was formed in 1998. Earlier in April this year HHS extended support for a clinical study of Zika blood-screening test developed by Roche Molecular Systems of Branchburg, New Jersey . Experience freedom and control over your molecular testing workflow like never before with the Panther system from Hologic. Our laboratory is taking steps to identify all specimens screened using the recalled Hologic kits since July, 2015. Panther Scalable Solutions provides an economical and scalable path to your lab's growth today and into the future. Hologic expects to update its financial guidance for fiscal 2017 after the transaction closes. The Amplified MTD test is part of Hologic's robust suite of molecular testing options designed to help diagnose microbial infectious diseases.. Amplified MTD specifically detects Mycobacterium tuberculosis (TB) rRNA directly and rapidly, while delivering the sensitivity of culture. More than 8% Global Organic Growth in All Businesses: Breast, Surgical, Skeletal and Diagnostics ex-COVID. Sun, August 14, 2016 (Released 9 August 2016) Today, the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response announced a $4.1 million agreement with Hologic, Inc. of Marlborough, Massachusetts, to advance the development of a blood screening test that will help detect the presence of Zika in the blood supply. High blood pressure is the single largest risk factor for this killer. The blood screening business manufactures blood screening products at a Hologic plant in Rancho Bernardo, Calf., which will be transferred to Grifols, along with about 175 employees, Hologic said. the CF newborn screening test. Hologic: Breakthrough Diagnostic & Medical Imaging Solutions Hologic History of Innovation: solutions and featured facts. The deal, first announced in December 2016, transferred ownership of Hologic's patents and development rights for nucleic acid testing, used to detect infectious agents in blood and plasma donations. The American Red Cross has been conducting blood tests for Zika as part of a clinical trial of aZika blood screening test made by Hologic and Grifols <grls.mc> the FDA approved in June. Measurement of HCV RNA is used to evaluate patient compliance and virological response during and after treatment. SARS-CoV-2 is detected by using one of the following assays: The UW SARS-CoV-2 Real-time RT-PCR assay targets two distinct regions within the N gene of SARS-CoV-2 (the causative agent for COVID-19). Per the terms of the agreement, the company will sell off its . Hologic, Inc and Grifols- market-leading partners committed to blood safety - announced that the US Food and Drug Administration (FDA) has approved use of the Procleix Zika virus blood screening assay on the Procleix Panther system under the agency's Investigational New Drug (IND) study protocol. Hologic Announces Preliminary Revenue Results for First Quarter of Fiscal 2022. MARLBOROUGH, Mass., Jan. 31, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) has completed the divestiture of its blood screening business to long-time commercial partner, Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS) for a purchase price of $1.85 billion in cash, the Company announced today. Hologic's share of NAT donor screening unit is a high margin, highly generative business with an EBITDA 1 above USD 160 million. 6. The Panther® system serves as the foundation of our automation with the option to add on: the Panther Fusion® module, Panther® Plus, Panther® Link and Panther® Trax. Thin Prep Vials are kept for 21 days after receipt of sample. 2004: Hologic received the National Medal of Technology and Innovation for blood-testing technologies and systems for the detection of West Nile Virus and identification of HIV-1 and HCV in human blood plasma and organ donors. Excluding its divested blood screening business, diagnostics revenues were $820.5 million, down 12%. The deal is expected to close in Q1, but Hologic said it doesn . The American Red Cross has been conducting blood tests for Zika as part of a clinical trial of aZika blood screening test made by Hologic and Grifols the FDA approved in June. 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