Quest Introduced First-To-Market Consumer-Initiated Blood Test for Alzheimer’s Disease Risk Assessment on Questhealth Website

On July 31, 2023, Quest Diagnostics, a leader in diagnostic information services, announced the introduction of the AD-Detect™ Test for Alzheimer’s Disease on questhealth.com – the first blood test available for consumer purchase that helps to assess the potential risk of developing Alzheimer’s disease based on a brain protein that contributes to the condition.

Quest introduced the novel innovation in the midst of a rapidly evolving landscape for Alzheimer’s disease treatment, which included new and emerging therapies, growing acceptance among medical professionals of blood tests to help with early Alzheimer’s disease detection, and growing recognition that non-pharmacological interventions can reduce Alzheimer’s disease risk.

In the AD-Detect screening test, levels of amyloid beta proteins are measured in plasma, the liquid portion of blood, from a single blood, draw in order to identify potential early warning signs of Alzheimer’s disease. In the brain, amyloid beta proteins are known to build up and form plaques, which are associated with the development of Alzheimer’s disease. Two amyloid beta peptides, A-42 and A-40, are measured by AD-Detect in plasma.

The consumer-initiated test makes use of the same expertise and technology as Quest’s clinical AD-Detect Amyloid Beta 42/40 Ratio test, a blood test that helps determine the risk of Alzheimer’s disease and is analytically validated. People can purchase AD-Detect through Quest’s consumer-initiated testing platform, giving them more control over the choice of when and how to assess their cognitive health. Along with guaranteeing that people have access to a continuum of care, the test program also provides clinical oversight for test ordering and results delivery through a network of independent doctors. Patients can discuss their results with a doctor to better understand what they might mean and to decide on a plan of action for ongoing care, including whether a follow-up visit with their general practitioner or a specialist might be necessary.

“We are seeing much attention on emerging therapies for Alzheimer’s disease, but with new treatment options will come the need to make screening and diagnosis more widely available. Blood tests like AD-Detect hold incredible potential to make Alzheimer’s disease risk assessment both accessible and convenient,” said Michael K. Racke, M.D., Medical Director of Neurology, at Quest Diagnostics. “We’re also seeing a push from consumers who have a desire to take more control of their health, including within more advanced areas like Alzheimer’s disease risk assessment.”

Even if they are not exhibiting symptoms, are 65 years of age or older, have experienced brain trauma, or have had a head injury, people who believe they are experiencing cognitive decline or whose loved ones may be able to detect mild cognitive impairment, such as memory loss, may benefit from taking the new Quest test. Blood tests like AD-Detect can help shed light on potential Alzheimer’s disease risk and assist people in facilitating necessary medical consultations.

As per DelveInsight’s “Alzheimer’s Disease (AD) Diagnostic Market” report, the global Alzheimer’s disease (AD) diagnostic market will grow at a CAGR of 10.97% during the forecast period from 2023 to 2028. The Alzheimer’s disease (AD) diagnostic market is observing optimistic market growth due to the factors such as a rise in the regulatory approvals for Alzheimer’s disease (AD) diagnostics across the globe. Further, the rising prevalence of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population will increase the prevalence of Alzheimer’s disease, thereby increasing the demand for Alzheimer’s disease diagnostic devices across the globe. Additionally, the increasing research and development of novel biomarkers, presence of key players in the market, increasing product launches and approvals, and others will create a requisite for Alzheimer’s disease diagnostics in the upcoming years. Therefore, the market for Alzheimer’s disease (AD) diagnostics is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

DuPont Completed Acquisition of Spectrum Plastics Group 

On August 1, 2023, DuPont announced that it completed the acquisition of Spectrum Plastics Group, a recognized leader in specialty medical devices and components markets.

Spectrum will join the Industrial Solutions line of business within the Electronics & Industrial segment, with a global workforce of about 2,200 employees and annual revenue of about $500 million. DuPont’s current offerings for biopharma and pharma processing, medical devices, and packaging, including DuPont’s Liveo™ silicone solutions and Tyvek® Medical Packaging, are complemented by Spectrum’s strategic focus on important, rapidly expanding therapeutics areas like structural heart, electrophysiology, surgical robotics, and cardiovascular. Due to the merger with Spectrum, DuPont’s current revenue in the fast-growing healthcare sector represents about 10% of its total revenue.

“I am pleased to welcome our talented Spectrum colleagues to DuPont,” said Ed Breen, DuPont Executive Chairman and Chief Executive Officer. “We are excited to add Spectrum’s best-in-class advanced manufacturing capabilities and decades-long customer relationships with the largest medical device OEMs to our existing healthcare portfolio. This acquisition fully aligns with our strategic objectives and is expected to increase overall top-line growth rates for DuPont through a broader and more integrated set of offerings for critical healthcare applications led by customer-driven innovation.”

According to DelveInsight’s “Medical Device Contract Manufacturing Market” report, the global medical device contract manufacturing market is projected to grow at a 10.82% CAGR during the forecast period (2023-2028). The medical device contract manufacturing market is witnessing an explosion in product demand owing to numerous reasons such as the increasing demand for complex and affordable medical devices. Another contributing factor is the rising prevalence of chronic disorders and the increasing geriatric population in the coming years. Additionally, the rising numbers of hospitals in developing countries and the rising IVD test volume will also play a key role in establishing an upward growth trend in the medical device contract manufacturing market during the forecast period from 2023 to 2028.

BD Received 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test

On August 1, 2023, BD (Becton, Dickinson and Company), a leading global medical technology company, announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.

The test uses a single nasal swab or a single nasopharyngeal swab sample to determine whether a patient has COVID-19, the flu, or RSV. It has been available in the United States since February thanks to an Emergency Use Authorization (EUA) from the FDA. The BD RVP test can help clinicians quickly implement the best treatment plan by reducing the need for numerous individual tests or doctor visits. The co-testing strategy also contributes to a faster diagnosis and an increase in testing capacity during the busy flu season.

Each unit of the BD MAX™ System, which is already in use at hospitals and medium-throughput labs, has the capacity to analyze hundreds of samples over the course of a 24-hour period. The RT-PCR BD MAX™ RVP test uses the straightforward, automated “walkaway workflow” of the BD MAX™ System to detect and distinguish the RNA of SARS-CoV-2, influenza A, influenza B, and RSV in about two hours.

The vast array of assays offered on the BD MAX™ System for respiratory infections, sexually transmitted infections, gastrointestinal infections, women’s health, and other conditions requires the respiratory viral panel. Customers can utilize user-defined protocols (UDP) and research-use-only assays with the BD MAX™ open system to quickly address emerging needs.

“Last year, we experienced a threat of a ‘tripledemic’ with COVID, flu, and RSV circulating simultaneously, and that threat remains for the coming respiratory season,” said Nikos Pavlidis, vice president, and general manager for Diagnostics at BD. “As patient symptoms and clinical presentation can be nearly identical, a combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients, and help manage the spread of the infections. The advanced robotic architecture of the BD MAX™ System automates manual, time-intensive processes, which has never been more important than in today’s environment of staffing shortages and laboratory scientist burnout.”

According to DelveInsight’s “Molecular Diagnostics Market” report, the global molecular diagnostic market was valued at USD 16.94 billion in 2022, growing at a CAGR of 9.16% during the forecast period from 2023 to 2028, to reach USD 28.44 billion by 2028. The increase in demand for molecular diagnostics is primarily attributed to the growing incidence of infectious diseases such as the sudden outbreak of COVID-19 and the rising burden of cancers across the globe. Moreover, rapid technological advancement in the molecular diagnostic product arena and increasing demand for point-of-care diagnostics along with rising consumer awareness regarding quick diagnostics, among others are some of the key factors responsible for the molecular diagnostic market growth during the forecasted period.

Natera Announced Completion of Enrollment to the Randomized, Phase III ALTAIR Trial of Signatera™ in Colorectal Cancer

On July 28, 2023, Natera, Inc., a global leader in cell-free DNA testing, announced the completion of enrollment to the randomized, double-blind phase III ALTAIR clinical trial (JapicCTI-205363/NCT04457297).

In the CIRCULATE-Japan adaptive trial platform, ALTAIR is the circulating tumor DNA (ctDNA)-guided treatment escalation arm testing the Signatera molecular residual disease test’s usefulness in patients with stage II–IV resectable colorectal cancer. The observational GALAXY study and the randomized phase III VEGA trial for ctDNA-guided treatment de-escalation are also included in CIRCULATE-Japan. Midway through 2024, the company anticipates releasing the first ALTAIR results.

The ALTAIR researchers have enrolled more than 240 patients who tested ctDNA-positive within two years of surgery but had no signs of disease on clinical or radiographic examinations. The treatment TAS-102, which is frequently prescribed to patients with metastatic CRC, or a placebo is randomly assigned to ctDNA-positive patients. Disease-free survival is the study’s main endpoint. A secondary endpoint is the removal of ctDNA. 

Following the publication of numerous new datasets highlighting the clinical utility of Signatera in CRC in 2023, enrollment to ALTAIR will be completed. Signatera has the ability to identify patients with stage II–IV resectable CRC who are at an increased risk of recurrence and to predict who is most likely to benefit from adjuvant chemotherapy, as shown by the results of >1,000 patients (>7,200 plasma time points) from GALAXY published in January. Similar findings from the same study’s expanded cohort of >2,000 patients (>3,800 plasma time points) were presented at the American Society of Clinical Oncology (ASCO) annual meeting in June 2023.

“In this study, we aim to establish the utility of Signatera in the adjuvant and surveillance settings by showing we can improve outcomes for patients with detectable ctDNA before it becomes evident on imaging,” said Dr. Takayuki Yoshino of the National Cancer Center Hospital East, Kashiwa, Chiba, Japan and primary investigator of the CIRCULATE-Japan trial. “Randomized studies such as ALTAIR can help provide compelling evidence to support the use of ctDNA testing as a tool to guide treatment decisions in CRC.” 

“The completion of enrollment to ALTAIR marks a significant milestone that will build on recent data from the GALAXY study and bring us one step closer to a future of ctDNA-guided cancer care,” said Dr. Minetta Liu, chief medical officer of oncology at Natera. “We are proud to partner with our collaborators from CIRCULATE-Japan to accelerate precision medicine and transform care for patients with resectable CRC.”

According to DelveInsight’s “Cancer Diagnostics Market” report, the global cancer diagnostics market was valued at USD 125.13 billion in 2022, growing at a CAGR of 9.43% during the forecast period from 2023 to 2028, to reach USD 214.88 billion by 2028. The increase in demand for cancer diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, growing manufacturers’ focus to develop advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, and others are anticipated to drive the global cancer diagnostics market during the forthcoming years.

Anteris’ Initiated US trial for DurAVR transcatheter heart valve

On August 9, 2023, in addition to building on successful studies in Europe, Anteris Technologies is conducting an early feasibility study in the US to further investigate the effectiveness of its DurAVR transcatheter heart valve (THV) in patients with aortic stenosis.

According to a ClinicalTrials.gov entry, 15 patients with severe native aortic stenosis are expected to enrol in the early feasibility study (NCT05712161) at locations in six different US states. The rate of mortality or disabling stroke at 30 days will be the study’s main endpoint. The device’s technical performance will also be evaluated right after the procedure.

In a statement by Dr Latib, the study’s national principal investigator, said: “Having previously travelled to Europe with Anteris to implant patients with DurAVR THV, I am delighted to note that the post-procedure patient outcomes seen in US patients at my center corroborate with data reported from previous cohorts. The ability to use this device with such excellent hemodynamic results, as well as ease of use, is incredible progress in the treatment of patients with severe aortic stenosis. We look forward to many more cases in the near future.”

The ComASUR delivery system from Anteris is used to implant the device, which is constructed from a single piece of bioengineered tissue with anti-calcification properties.

Wayne Paterson, the CEO of Anteris, said in a statement that the study brings the device’s US commercialization one step closer as the company works to obtain FDA approval.

According to DelveInsight’s “Transcatheter Aortic Valve Replacement Market” report, the global Transcatheter Aortic Valve Replacement Market was valued at USD 3.23 billion in 2022, growing at a CAGR of 15.41% during the forecast period from 2023 to 2028 to reach USD 7.64 billion by 2028. The demand for transcatheter aortic valve replacement devices is primarily being boosted by the increasing prevalence of aortic stenosis disorder, rise in cardiovascular disorders, increasing demand for TAVR procedures, increasing prevalence of aortic regurgitation and the technological advancements pertaining to the transcatheter aortic valve replacement arena which are expected to increase in the product demand thereby contributing in the growth of the transcatheter aortic valve replacement devices market during the forecast period from 2023-2028.