Chlamydial Pneumonia

BRNO, Czech Republic, Oct. 3, 2023 /PRNewswire/ -- GeneProof, a leader in molecular diagnostics, today announced the addition of six new IVDR-certified PCR kits to its expansive portfolio. This comes as a testament to the company's dedication to delivering its entire portfolio of approximately 80 products as IVDR compliant by 2027. Currently, 27 products are IVDR cleared, with 16 that are Notified Body certified in class C and B. These include tests for infectious diseases and immuno-compromised/transplant. The newly added IVDR kits focus on the diagnosis of sexually transmitted infections and include: Multiplex CNMX: Designed for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium. Duplex MGH: Designed for the detection of Mycoplasma genitalium/hominis. Multiplex MUPX: Designed for the detection of Mycoplasma hominis, Ureaplasma urealyticum, and Ureaplasma parvum. Singleplex Kits: Designed for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Chlamydia pneumoniae (CP), respectivly. GeneProof was among the first to obtain the EU Certificate for Quality Management System under the new Regulation (EU) 2017/746 IVDR. The company started its IVDR compliance journey early, positioning itself as one of the first European companies to operate in full adherence with the IVDR in January of 2023. The extensive portfolio is built on its innovative "one workflow" technology. One workflow allows combining PCR kits from different diagnostic groups (including panels for respiratory infections and vector-borne diseases) in a single run for ease-of-use and compatibility with a wide range of qPCR instruments. GeneProof also offers a specialized panel for thrombotic mutations. Additional IVDR certified kits will be available before the end of 2023. About ALPCO-GeneProof ALPCO was founded in 1991 as an importer and distributor of immunoassay-based products for the North American life science markets. The company has since evolved into a leading producer of novel immunodiagnostic reagents for specialty testing laboratories. In 2022, ALPCO merged with GeneProof, a Czech Republic-based provider of specialty molecular diagnostic solutions. Founded in 2005, GeneProof offers a portfolio of approximately 80 products, 27 of which are IVDR PCR test kits for infectious diseases and genetic mutations, as well as a suite of proprietary instrumentation for clinical laboratories of all sizes. For additional information, please visit and . SOURCE ALPCO-GeneProof

Rising demand for PCR-based respiratory panels stimulating growth in Europe and Middle East & Africa respiratory panel testing market Europe emerged as most lucrative market in 2020 because of rising prevalence of respiratory diseases and increasing geriatric population in countries such as Germany and the U.K. WILMINGTON, Del., Oct. 24, 2022 /PRNewswire/ -- The last few years have witnessed increase in patient population suffering from respiratory diseases in countries in Europe and Middle East and Africa regions. As a result, demand for respiratory panels to test patients has risen which has helped in market growth. The Europe and Middle East & Africa respiratory panel testing market is projected to advance at CAGR of 5.1% during the forecast period, starting in 2022 and ending in 2031. Prominent market players are looking to generate new revenue streams and gain a competitive edge over other market players by launching new products. Get Exclusive PDF Sample Copy of Europe and Middle East & Africa Respiratory Panel Testing Market – Well-established market players are also looking to expand their presence in global market and increase their revenue, by signing collaborative agreements. Key Findings of Europe and Middle East & Africa Respiratory Panel Testing Market Study Increasing Demand for PCR-based Respiratory Panels Triggering Growth in Europe and Middle East & Africa Respiratory Panel Testing Market: The last few years have witnessed an increase in demand for PCR-based panels to identify pathogens. Furthermore, PCR-based panels are emerging as suitable alternative to viral culture to identify viral nucleic acids and offer results with improved specificity and sensitivity. Leading manufacturers are increasing the production of multiplex PCR-based virus panels to test patients suffering from influenza, rhinovirus, and respiratory syncytial virus. Rising Demand for Syndromic Full Multiplex Panels Boosting Market Growth: Syndromic full multiplex panel type segment held a major share in Europe and Middle East & Africa respiratory panel testing market, in 2020. Rising use in identification of multiple target pathogenic DNA or RNA, as well as increased deployment in clinical care emerged as key factors, driving the growth in the segment and contributed to respiratory panel testing market growth in Europe and Middle East & Africa Increasing Hospital Admissions Could Augment Growth in Europe and Middle East & Africa Respiratory Panel Testing Market: Hospital end-use segment is expected to hold a major share in the Europe and Middle East & Africa respiratory panel testing market, during the forecast period. Rising prevalence of respiratory diseases is expected to lead to increase in hospital admissions, which could fuel the demand for respiratory panel testing and boost the market growth Ask for References – Europe and Middle East & Africa Respiratory Panel Testing Market: Key Drivers Increasing prevalence of respiratory tract infections is one of the key growth drivers of Europe and Middle East & Africa respiratory panel testing market Rising prevalence of hospital-acquired infections is expected to fuel the demand for respiratory panel testing and trigger the market growth in europe and middle east and africa Europe and Middle East & Africa Respiratory Panel Testing Market: Regional Market Insights Europe emerged as the dominant region in global market in 2020. Increase in prevalence of respiratory disorders and rising geriatric population in countries such as the U.K. and Germany played key roles in the region emerging as the leader in overall market Germany is anticipated to emerge as the leading country in the market in Europe during the forecast period because of presence of well-established medical diagnostics industry, as well as outbreak of COVID-19 pandemic in the country, leading to increase in demand for respiratory testing panels Make an Enquiry Before Buying – Europe and Middle East & Africa Respiratory Panel Testing Market: Key Players Competition landscape in Europe and Middle East & Africa respiratory panel testing market is fragmented, owing to the presence of numerous well-established market players. Few leading players include Dickinson and Co., Becton, Medline Industries, QIAGEN, and Anatolia Geneworks. Europe and Middle East & Africa respiratory panel testing market is segmented as follows: By Specimen Type Viruses Adenovirus Severe Acute Respiratory Syndrome Coronavirus 2 RSV Human Metapneumovirus Rhinovirus/Enterovirus Parainfluenza Virus Flu A Coronavirus Flu B H1N12009 Others Bacteria Mycoplasma Pneumoniae Chlamydophila Pneumonia Bordetella Pertussis Bordetella Parapertussis By Panel Type Syndromic Full Multiplex Panel Low Flex Panel By End-use Hospital Point-of-Care Testing Ref Laboratories Hospitals Others Regions Covered Europe Middle East & Africa Modernization of healthcare in terms of both infrastructure and services have pushed the healthcare industry to new heights, Stay Updated with Latest Healthcare Research Reports by Transparency Market Research: Cancer Diagnostics Market: The global cancer diagnostics market is anticipated to reach more than US$ 335.7 Bn by the end of 2031 at a CAGR of 7.4% from 2022 to 2031. Non-invasive Prenatal Testing Market: The global non-invasive prenatal testing market is anticipated to reach more than US$ 8.4 Bn by the end of 2031 at a CAGR of 14.8% from 2022 to 2031. Diagnostic Imaging Services Market: The global diagnostic imaging services market is anticipated to be valued more than US$ 544.7 Bn by the end of 2031 at a CAGR of 4.1% from 2022 to 2031. Diagnostic Reagents Market: The global diagnostic reagents market is anticipated to reach more than US$ 85.8 Bn by the end of 2031 at a CAGR of 6.5% from 2022 to 2031. Cervical Cancer Diagnostic Tests Market: The global cervical cancer diagnostic tests market is expected to exceed value of US$ 13.6 Bn by the end of 2031 at a CAGR of 4.6% from 2022 to 2031. Central Lab Market: The global central lab market is expected to reach the value of US$ 4 Bn by the end of 2031 at a CAGR of 5.4% from 2021 to 2031. In Vitro Diagnostics Market: The global in vitro diagnostics market is expected to reach the value of US$ 115.43 Bn by the end of 2028 at a CAGR of 6.3% from 2021 to 2028. Companion Diagnostics Market: The global companion diagnostics market is expected to reach the value of US$ 9.30 Bn by the end of 2028 at a CAGR of 9% from 2021 to 2028. About Transparency Market Research Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyse information. Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. For More Research Insights on Leading Industries, Visit Our YouTube Channel and hit subscribe for Future Update - Contact Rohit Bhisey Transparency Market Research Inc. CORPORATE HEADQUARTER DOWNTOWN, 1000 N. West Street, Suite 1200, Wilmington, Delaware 19801 USA Tel: +1-518-618-1030 USA – Canada Toll Free: 866-552-3453 Website: Blog: Email: [email protected] Logo: SOURCE Transparency Market Research

BOSTON, Oct. 18, 2021 (GLOBE NEWSWIRE) --Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced that the first patient has been enrolled in the company’s Phase 2b study evaluating the safety and efficacy of NUZYRA® (omadacycline) for the treatment for nontuberculous mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc), a rare disease for which there is no FDA-approved therapy. “We are excited to have initiated patient enrollment in this important study. We look forward to the trial producing important data that will further inform the potential of NUZYRA for the treatment of Mycobacterium abscessus complex with pulmonary disease. The study builds on the growing body of real-world evidence for NUZYRA,” said Randy Brenner, chief development and regulatory officer of Paratek. “We believe NUZYRA, a once-daily, oral, broad-spectrum antibiotic, has the potential to address important unmet medical needs for patients with this rare disease.” Pulmonary infections caused by MABc affect approximately 11,500 patients in the United States. Patients have a myriad of symptoms including severe fatigue, fever, cough and shortness of breath. The standard of care typically involves a combination of multiple antibiotics not approved for this disease, which can often be life-long in duration and complicated by long-term tolerability challenges and multiple adverse events. “NTM lung disease due to Mycobacterium abscessus can be a debilitating condition which can potentially lead to fatal respiratory failure. People with existing lung conditions are particularly susceptible,” said Kevin Winthrop, M.D., M.P.H., professor of infectious diseases, Oregon Health & Science University, and principal investigator. “This disease is notoriously resistant to most antibiotics and is very challenging to treat. There are currently no FDA-approved therapies for Mycobacterium abscessus, and I am encouraged that there is the potential for a new oral treatment on the horizon for these patients.” About the Study The Phase 2b study is a placebo-controlled, randomized monotherapy study of Mycobacterium abscessus pulmonary disease in patients who are not receiving other treatments. The U.S.-based study will enroll approximately 75 subjects, randomized in a 1.5 to 1 ratio. The primary study endpoints are improvement in symptoms and safety and tolerability following 12 weeks of treatment. Due to the small numbers of patients with this rare disease, Paratek expects the study will take about two years to complete enrollment. More information can be found at clinicaltrials.gov under the study ID number NCT04922554. About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use. The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek is also conducting a Phase 2b Study in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex with NUZYRA. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States. Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. In 2019, Paratek was awarded a contract from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), now valued at up to approximately $304 million, to support the development and U.S.-based manufacturing of NUZYRA for pulmonary anthrax. For more information, visit or follow us on LinkedIn and Twitter. About NUZYRA NUZYRA® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and other drug-resistant strains. Indications and Usage NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms: Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae and Chlamydophila pneumoniae. Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae and Klebsiella pneumoniae. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Important Safety Information Contraindications NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients. Warnings and Precautions Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions The most common adverse reactions (incidence =2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia and constipation. Drug Interactions Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. Use in Specific Populations Lactation: Breastfeeding is not recommended during treatment with NUZYRA. To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information for NUZYRA at . Forward Looking Statements This press release contains forward-looking statements including statements related to our clinical studies for NTM and the potential for NUZYRA to fill an unmet medical need for NTM patients. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein. CONTACT: For Investors: Hans Vitzthum LifeSci Advisors ir@ParatekPharma.com Phone: 617 430 7578 For Media: Christine Fanelle Scient PR Christine@scientpr.com Phone: 215 595 5211