Skywater Technology: Sequencing Technology is Critical to Identify Mutations of the Virus

March 16, 2020

Skywater Technology announced its partnership with MGI (a member of BGI Group) to supply critical components used by MGI’s DNA sequencing system DNBSEQ-T7, one of the first officially approved products by the National Medical Products Administration (NMPA – essentially China’s version of the FDA), under the emergency approval process for the coronavirus (COVID-19).

MGI, a global genomics platform company, along with its affiliates, was very quick to respond to the novel coronavirus virus and is bringing its full genomics expertise and resources to the front lines in the fight against it.

MGI has a manufacturing plant in Wuhan, China, the epicenter of the COVID-19 outbreak, where MGI delivered and deployed its NMPA-approved DNBSEQ-T7 sequencing systems for sequencing-based COVID-19 detection solutions.

SkyWater has been working with MGI for several years and supplies a component of BGI’s Flowcells (microfluidic MEMS devices). This component forms the basis for one of the consumables used in the sequencing kit in the DNBSEQ-T7 system, an ultra-high-throughput sequencing system manufactured by MGI.

At the time of this announcement, MGI is also providing automated sample preparation systems to help labs to increase the capacity to aid in more widespread and rapid screening in the U.S.

“As concerns rise about the coronavirus global pandemic, the pressure is on to enable even faster, more accessible testing. We are pleased to be working with genomics leader MGI and playing a role as a U.S. manufacturer in cutting-edge technology solutions that are making an important contribution to the detection of COVID-19,” said Thomas Sonderman, SkyWater President.

“Products from MGI and its affiliates are ready for international delivery to assist the global efforts in fighting the coronavirus pandemic, a number of which have already been sent to other countries,” said Dr. Yongwei Zhang, BGI Group VP & CEO, Americas Region. “SkyWater has been an excellent partner. We very much appreciate their support over the years, and we look forward to our ongoing partnership as we continue providing the highest quality genomic data at rapid turnaround times.”

SkyWater is certified to the ISO 13485 Quality Standard for Medical Devices to support the design, development and fabrication of DNA sequencing and other biochip applications in a wide range of emerging biomedical market segments.

Coronavirus and Telehealth Support Groups

March 16, 2020

XRHealth clinics note they are now certified in Boston, Connecticut, Florida, Michigan, Washington D.C., Delaware, California, New York, Texas, North Carolina, and many others and are covered by Medicare and most major insurance providers.

Due to the immediate need of this technology because of social distancing in response to the spread of coronavirus, XRHealth will make the technology available sooner than originally expected and it will officially be available to the public on April 1^st.

XRHealth support groups are tailored for patients with the following conditions: Multiple Sclerosis, Parkinsons, breast cancer, menopause, an injury that effected motor function, anxiety, chronic pain, fibromyalgia, substance abuse, post-stroke rehabilitation, brain injury and there will also be general support group for the elderly population that is most impacted by the coronavirus.

The ability for patients to connect with each other in VR and with a group moderator is powered by Foretell Reality, a subsidiary company of The Glimpse Group, Inc. and a platform provider of VR environments and toolsets that facilitate authentic human interactions between remote individuals and groups in life-like, secure and virtual spaces.

“Virtual Reality is providing healing opportunities to patients that once could not leave their homes and were suffering in silence,” says Eran Orr, CEO of XRHealth. “Virtual Reality capabilities offer support and assistance to patients around the world, in the comfort of their home. This is especially rewarding to patients that are immobile or unable to engage with a group in-person. It also provides high-quality care from leading doctors that patients might otherwise not have had access to.
One of the most troubling issues during the coronavirus crisis is that people are forced to be isolated and we believe that virtual support groups in VR will be able to ease the loneliness and isolation.”

Dror Goldberg, General Manager of Foretell Realty added: “VR brings people together into the same immersive environment, fostering intimate interaction in powerful ways that are not possible via other mediums of remote communication. Specifically for group therapy, studies have shown that self-representation in VR through avatars helps patients overcome initial hesitation and facilitates the sharing of personal information and emotions.”

New FDA Guidance and Labeling Changes Affecting PneumoLiner, the Only 510(k)-Cleared Containment Device Reports Olympus

March 16, 2020

In a recent press release, the FDA states about the PneumoLiner: “While the device itself remains unchanged since its prior marketing authorization, today’s clearance updates the labeling for this device to better define the appropriate patient population for the safe and effective use of this device, including stating that the device should only be used in women who have fibroids if they are pre-menopausal and under 50 years old.”

The FDA safety communication update on power morcellation includes additional recommendations including:

That health care providers use tissue containment systems when using laparoscopic power morcellators, and that they ensure the laparoscopic power morcellator and tissue containment system are compatible, legally marketed laparoscopic power morcellation containment systems intended to isolate and contain tissue that is considered benign.
As demonstrated in testing, use of a containment system confines morcellated tissue within the containment system, which may prevent the peritoneal spread of cancerous tissue.
Laparoscopic power morcellation (with a compatible containment system) should only be used in the appropriate patient population:
- women without uterine fibroids undergoing hysterectomy
- and women with fibroids, provided they are pre-menopausal and under age 50 with fibroids (with no suspicion of malignancy).

The leading gynecological laparoscopy association, AAGL, immediately endorsed the FDA’s guidance, with the following statement from its President, Jubilee Brown, MD: “The specification of age-related risk is consistent with scientific data and reflects clinical experience allowing power morcellation in low- risk patients when performed with a containment system compatible with the laparoscopic power morcellator. Utility of a contained tissue extraction system in a low- risk population appears to mitigate the risk of poor outcomes that may be associated with uncontained power morcellation.” The AAGL encouraged its members to submit electronic comments to the FDA’s Federal Register.

These modifications clarify power morcellation usage guidelines along with containment in appropriately selected patients. Further, the FDA clarifies the appropriate patient population by eliminating the ambiguous term “peri-menopausal” from the contraindications, and adds an easier-to-follow age restriction.

Novacyt: Coronavirus Test Update

March 16, 2020

Novacyt announced an update regarding the novel coronavirus (COVID-19) test developed by Primerdesign, its molecular diagnostics division.

Following the completion of Public Health England’s (PHE) formal evaluation of Primerdesign’s COVID-19 test, as announced on March 12, 2020, the government agency has commenced ordering the test. Orders are initially for eight hospitals to provide stocks in those locations for four weeks of planned testing. The total value of the initial purchase is approximately £1.0 million (€1.1 million), which is the single largest order the Company has received to date for its COVID-19 test.

As of 13 March 2020, Primerdesign has sold and received orders for over £3.7 million (€4.3 million) of its CE-Mark and research use only (RUO) COVID-19 tests, which includes the order received from PHE. This represents approximately eight months of sales for the division under normal circumstances. This is additional revenue to the core Novacyt business.

Graham Mullis, Chief Executive Officer of Novacyt, commented: “We welcome Public Health England’s decision to use our COVID-19 test in the UK and I am delighted to see that Novacyt will now be supporting one of its home markets during these challenging times. The number of countries Novacyt is now supplying with its COVID-19 test has reached over 60 and we expect this will continue to increase. “The team at Novacyt and its key suppliers are working extremely hard to support clinicians around the world in the fight against this pandemic and, as a Chief Executive Officer, I am immensely proud of everyone’s commitment.”

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

Smoking Cessation Multicenter Study Evaluating Use of Deep TMS at Society for Research on Nicotine & Tobacco 2020

March 16, 2020

Dr. Aron Tendler, Chief Medical Officer at BrainsWay, presented the data in an oral presentation entitled, “Smoking Cessation Induced by Deep Magnetic Stimulation: A Double-Blind Sham Controlled Multi-Center Study,” which took place today, Saturday, March 14, 2020, from 10:45-11:00 AM CT.

“Tobacco smoking is one of the primary causes of preventable death and also leads to other serious conditions, such as cancer and heart disease,” said Dr. Tendler. “While there are several treatment options currently available, the development of other therapies is critical to increasing the continuous quit rate among smokers. Findings from our multicenter study indicate that Deep TMS could potentially serve as a treatment option for inducing smoking cessation. BrainsWay is proud to be at the forefront of non-invasive brain stimulation for addiction and we are focused on working to make Deep TMS available to patients attempting to successfully quit smoking as expeditiously as possible.”

The results presented are from a randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of Deep TMS treatment as an aid in reducing cigarette smoking in individuals suffering from chronic smoking addiction. The trial was conducted at 14 sites, primarily in the U.S., and enrolled 262 eligible subjects randomized into two groups: an active treatment group treated with BrainsWay’s proprietary H4-coil targeting addiction-related brain circuits, and a sham (placebo) control group. The primary endpoint of the study was a comparison between the two groups of the four-week continuous quit rate (CQR), representing abstinence during a consecutive four-week period.

Of the 168 participants in the study who actually completed three weeks of active Deep TMS or sham treatment, plus the mandatory additional three weeks of follow-up (reaching the six-week endpoint), the CQR was 28.4% in the treatment group compared to 11.7% in the sham group (p=0.0063). The primary endpoint was defined based on the CQR among those subjects who received at least one Deep TMS (or sham) treatment session and had at least one post-baseline assessment, even if not completing the treatment period. Within this cohort (which consisted of 234 participants and included dropouts) the CQR was 19.4% in the treatment group and 8.7% in the sham group (p= 0.0174).

Jupiter Medical Center Adjusts Visitor Policy, Elective Procedures

March 13, 2020

Jupiter Medical Center today announced an update to its visitor policy to allow only one healthy visitor at a time, per patient.

Jupiter Medical Center advises visitors will be screened for potential exposure, travel history and upper respiratory tract symptoms. This new policy went into effect on Wednesday, March 18, and will remain in place until further notice.

Jupiter Medical Center is also in the process of rescheduling non-urgent, elective surgeries. This measure will minimize any potential spread among patients, as well as reduce the risk of exposure to team members and frontline providers. Jupiter Medical Center will continue to perform non-elective, urgent and emergency surgeries.

“In accordance with the Centers for Disease Control (CDC) and the American College of Surgeons recommendations, we are rescheduling elective surgeries to protect the health of our patients and caregivers at this time,” said Dr. Amit Rastogi, president and CEO of Jupiter Medical Center. “We recognize the impact on those patients whose procedures are being delayed and certainly look forward to amending our policy as events warrant.”

Jupiter Medical Center continues to conduct multidisciplinary training drills in preparation for screening, diagnosing, isolating and treating any potential cases of COVID-19, as well as ensuring the proper use of personal protective equipment in accordance with the Centers for Disease Control and Prevention recommended guidelines.

Agilex Biolabs Announces 30% Labs Expansion and Offers Virtual Lab Tours During COVID-19 Outbreak

March 13, 2020

Agilex Biolabs also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:

Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine / biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)

Agilex Biolabs CEO Jason Valentine said they will now be offering virtual tours of the lab for customers who have travel restrictions during the current Covid-19 outbreak.

CEO Jason Valentine said:

“Our FDA-inspected facilities have more than 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year we will analyse more than 60,000 samples for pharma / biotechs from US, Europe and APAC.

“By combining specialised expertise, technological innovation and a 20-year track record, we have supported hundreds of preclinical and clinical trials around the world.

“Our world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.”

Learn more:
– Watch the Agilex Biolabs video: https://youtu.be/3lyodiqqM_k
– Download the New Services data sheet: https://tinyurl.com/AgilexBiolabs

COVID-19 Update: FDA Gives Flexibility to NYS Department of Health, FDA issues Emergency Use Authorization Diagnostic Testing

March 13, 2020

First, the agency issued enforcement discretion and is not objecting to the New York State Department of Health (NYSDOH) authorizing certain laboratories in New York to begin patient testing after validating their tests and notifying the NYSDOH. Under NYSDOH’s approach, laboratories will provide validation data to NYSDOH within 15 days in lieu of pursuing an Emergency Use Authorization (EUA) with FDA.

Second, the FDA authorized the Roche cobas SARS-CoV-2 Test, the third Emergency Use Authorization (EUA) granted for a diagnostic test during the COVID-19 outbreak.

“These actions today show our commitment to working around the clock to help expedite the availability of tests. This NYSDOH action shows the FDA’s extreme flexibility and adaptability during times of public health emergencies,” said FDA Commissioner Stephen M. Hahn, M.D. “As a practical matter, what this action means is that labs, authorized by NYSDOH, will not engage with FDA to begin patient testing. Nor will they get an Emergency Use Authorization from the FDA. These labs will interact solely with NYSDOH, which should expedite the availability of patient testing in New York State. This action demonstrates FDA’s responsiveness to the needs of our country during this time.”

The FDA is granting this flexibility to NYSDOH based on the urgent public health need for additional testing capacity. The FDA weighed several factors in this decision, including that the NYSDOH has a long-established framework in place for oversight of laboratory developed tests in New York State. The FDA had also previously accredited Wadsworth be a third-party reviewer for certain molecular tests.

Additionally, the FDA issued an EUA to Roche Molecular Systems for its cobas SARS-CoV-2 test within 24 hours of receiving the application. This is the first commercially distributed diagnostic test to receive an EUA during the COVID-19 outbreak. To expedite access to this test, FDA did not object to Roche pre-positioning its test so that labs could be ready to initiate testing immediately upon authorization of the EUA. Because of that pre-positioning, laboratories can immediately run tests on Roche’s high-volume platform, which will greatly increase national testing capacity.

“We have been encouraging test developers to come to the FDA and work with us,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Since the beginning of this outbreak, more than 60 developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process. Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory developed tests for this emergency.”

Additional Resources:

PreCheck Health to Exclusively Distribute Coronavirus COVID-19 Test in Ecuador

March 13, 2020

Justin Anderson, CEO of PreCheck Health Services Inc., commented, “It’s been a productive month for PreCheck Health. In early March we entered into the $33 billion global infectious disease diagnostic testing sector with an exclusive agreement with Co-Diagnostics to distribute their COVID-19 tests as well as other infectious disease kits in Russia. We are pleased to announce today that we have expanded our relationship with a distribution agreement for Ecuador.

The decision for PreCheck to distribute for Co-Diagnostics and specifically their Logix Smart™ Coronavirus COVID-19 Test is due to the test’s excellent characteristics in terms of sensitivity and specificity, the two benchmarks for accuracy in PCR tests. In today’s global crisis where governments, professional sports, college sports and public schools are being closed or suspended on the basis of a single test, we felt that high accuracy was critical for our comfort level, resulting in our decision to choose Co-Diagnostics.”

Co-Diagnostics CEO Dwight Egan commented, “We are pleased to enter into these agreements with PreCheck. They are part of a strong demand we are experiencing for our Covid-19 tests. The agreements also highlight Co-Diagnostics’ commitment to supporting the global response to coronavirus. As such, we are delighted to have PreCheck as a customer, focused on distributing these products in Russia and Ecuador.”

TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery

March 13, 2020

“We are pleased to have received this important clearance earlier than expected. Machine vision is the next major advance in digital surgery,” said Anthony Fernando, TransEnterix president and CEO.

He noted, “Our system is designed to significantly advance the sensing capabilities of computer-assisted surgery. With this hardware and software system, the Senhance System will gather and interpret visual information from the surgical field. The capabilities now cleared will be focused on optimizing visualization and camera control in ways never before offered in robotic or digital surgery. These initial capabilities represent the first step in our journey to bring the benefits of augmented intelligence and machine vision to surgery.”

The ISU enables machine vision-driven control of the camera for a surgeon by responding to commands and recognizing certain objects and locations in the surgical field. The ISU hardware is also designed to be compatible with planned future augmented intelligence features such as scene cognition and surgical image analytics that are expected to continue to drive meaningful innovations in digital laparoscopy with Senhance.

“This is the beginning of a new era in digital surgery,” said Dr. Amit Trivedi, chair of surgery at Hackensack Meridian Health Pascack Valley Medical Center and a participant in the design and usability studies conducted in support of the 510(k) submission of the ISU. “Surgery is the skilled real-time application of vision, experience, precise motion and decision making. The opportunity to use a computer to see aspects of the field and guide surgery is enormous. I am eager to utilize machine vision to better control the camera seamlessly during my surgeries.”

This Intelligent Surgical Unit is compatible with both the global installed base of Senhance Surgical Systems and with third-party vision systems that are currently supported by Senhance.

XRHealth clinics note they are now certified in Boston, Connecticut, Florida, Michigan, Washington D.C., Delaware, California, New York, Texas, North Carolina, and many others and are covered by Medicare and most major insurance providers.

Novacyt announced an update regarding the novel coronavirus (COVID-19) test developed by Primerdesign, its molecular diagnostics division.

Dr. Aron Tendler, Chief Medical Officer at BrainsWay, presented the data in an oral presentation entitled, “Smoking Cessation Induced by Deep Magnetic Stimulation: A Double-Blind Sham Controlled Multi-Center Study,” which took place today, Saturday, March 14, 2020, from 10:45-11:00 AM CT.

Jupiter Medical Center today announced an update to its visitor policy to allow only one healthy visitor at a time, per patient.

Agilex Biolabs also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:

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