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SAN DIEGO (CNS) - San Diego-based Agena Bioscience announced today that its diagnostic system for detection of SARS-CoV-2, the virus that causes COVID-19, received Emergency Use Authorization from the U.S. Food and Drug Administration.The company was granted approval Monday on an emergency basis for its MassARRAY SARS-CoV-2 panel for use in clinical laboratories.The FDA's Emergency Use Authorization allows for the use of unapproved medical products during an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions. Emergency Use Authorization has been granted to a large number of companies since the COVID-19 pandemic began for rapid approval of diagnostic tests, personal protective equipment, ventilators and other devices.``Agena is proud to offer a truly scalable platform to support the increasing demand for high-throughput SARS-CoV-2 testing,'' said Agenda CEO Peter Dansky. ``To address the crisis presented by COVID-19, labs need to cost- effectively process large numbers of samples. The MassARRAY System is the perfect tool for that.''The company says its panel targets five regions of the viral genome, and that with its authorization, the company hopes to help laboratories increase testing without the concerns of instrument or reagent availability.``The unique characteristics of the Agena detection technology provide significant supply chain advantages,'' said Jason Halsey, Agena's senior vice president of technology and operations. ``Agena proactively sourced and secured materials to provide uninterrupted product availability to our customers. Agena's MassARRAY SARS-CoV-2 panel kits and instruments are ready for immediate deployment, and we are equipped to supply mill 1741

SAN DIEGO (CNS) - San Diego-based medical equipment manufacturer ResMed Corp. has agreed to pay more than .5 million to resolve allegations that it paid kickbacks to suppliers, sleeps labs and other health care providers in exchange for referrals and prescriptions for its products, the Department of Justice announced Wednesday.The government accused ResMed of violating the Anti-Kickback Statute of the False Claims Act by providing free or below-cost medical equipment to companies in several states. Court documents state that ResMed's products -- which treat sleep apnea and other sleep disorders -- were provided to companies that in some cases began writing prescriptions to their patients entirely for ResMed equipment.Prosecutors say some examples of ResMed kickbacks included free home sleep testing devices, free or below-cost positive airway pressure masks and diagnostic machines, and free telephone call center and patient outreach services that allowed the companies to order resupplies for sleep apnea patients.RELATED: San Diego suing SDG&E for allegedly delaying pure water projectThe settlement agreement resolves five lawsuits filed by whistleblowers, who will collectively receive around .2 million out of the total settlement."Paying any type of illegal remuneration to induce patient referrals undermines the integrity of our nation's health care system," said Assistant Attorney General Jody Hunt. "When a patient receives a prescription for a device to treat a health care condition, the patient deserves to know that the device was selected based on quality of care considerations and not on unlawful payments from equipment manufacturers." 1679

SAN DIEGO (CNS) - Protesters are planning to assemble Saturday outside the California Democratic Party Convention in San Diego as part of a ``Working People's Day of Action,'' according to a local labor organization.The rally will start outside Convention Center Park at 3:30 p.m., according to the San Diego and Imperial Counties Labor Council. Workers will advocate for their rights two days before the U.S. Supreme Court is expected to hear a case that could have a dramatic impact on the ability of workers' unions to raise money.The case, Janus v. AFSCME Council 31, will determine whether public sector labor unions are allowed to charge mandatory fees to all workers in their organizations. The case could overturn the Supreme Court's 1977 ruling in Abood v. Detroit Board of Education, which held that because federal law requires them to represent all employees regardless of union membership, public sector unions can charge fees to non-members to offset non-political costs.Related: California Democratic Convention beginsLabor icon Dolores Huerta, NextGen America founder Tom Steyer, American Federation of Teachers President Randi Weingarten and AFL-CIO Executive Vice President Tefere Gebre are all expected to speak at the rally.Similar rallies are planned in 27 other cities nationwide, including New York, Washington, D.C., Chicago, Philadelphia, Memphis and Miami, according to the labor council.Related: "Poor Peopl's Campaign" calls for protest Monday``Standing together on Feb. 24 is just as important today as it would've been 50 years ago,'' said Michael Avant, a UC San Diego patient transporter and AFSCME Local 3299 member. ``Together we can win dignity, a decent living, and make our voices heard.'' 1739

SAN DIEGO (CNS) - The San Diego Animal Welfare Coalition today will join a nationwide effort to ``Clear the Shelters'' today for the duration of August.The campaign to get as many pets adopted as possible is a little different this year. The Clear the Shelters event, instead of being a single- day effort, will be a month-long adoption drive to allow for virtual adoption consultations by appointment. In addition to promoting adoptions, the campaign encourages donations to participating shelters.``San Diego Humane Society is excited to be working to ``Clear the Shelters,'''' says Gary Weitzman, president and CEO of San Diego Humane Society. ``This important nationwide campaign will give tens of thousands of animals throughout San Diego County a second chance.''Since 2015, the Clear the Shelters campaign has helped more than 410,000 pets find new homes nationwide.``The County of San Diego's Department of Animal Services shelters in Bonita and Carlsbad have many wonderful animals waiting to be adopted into loving homes,'' said Kelly Campbell, director of animal services for the county. ``While the pandemic has certainly created challenges for us all, now may be the perfect time to add a new pet to the family, especially if you find yourself spending more time at home.''The San Diego Humane Society said benefits of adopting a pet include being more affordable, knowing the animal has been assessed for behavior and medical conditions and allowing prospective owners to receive pet-specific resources. The society offers training advice, pet supplies and educational information to support pet families for the lifespan of a pet. ``During the pandemic, we have learned how to embrace change, and that change could include an adoptable pet,'' said Judi Sanzo, president of Rancho Coastal Humane Society. ``Shelters around the country want to remind you that your new best friend could be waiting, tail wagging and ready to join you while you work from home. While Rancho Coastal continues to match pets with their new families, it's important to remember that the virus may be temporary, but pets are a lifetime commitment.'' 2148

SAN DIEGO (CNS) - The San Diego City Council declined to report details of its closed-door discussion Tuesday on a draft appraisal of price and payment terms for the city's potential sale of the SDCCU Stadium site to San Diego State University.The council met in closed session to discuss the undisclosed terms of the appraisal with its negotiating team, composed of officials in various city departments and the city attorney's office. Both the city and SDSU have expressed an intent to exchange the property for "fair market value," but what that entails remains opaque.D.F. Davis Real Estate estimated the fair market value of the site sits at .2 million, according to documents.The city is currently in the process of selling a 132-acre parcel of land to SDSU as the university intends to redevelop the parcel, which includes SDCCU Stadium, into a 35,000-seat stadium to be primarily used by the university's football team, a satellite campus, a park along the San Diego River and commercial and residential space.After the closed session, City Councilwoman Barbara Bry called for the draft appraisal to be released to the public and for all future discussions of the sale to take place in an open session."It is now time for SDSU to make an offer which honors the terms of Measure G and the promises that were made during the campaign," Bry said in a statement. "This offer should include a commitment to building the river park and designing a transit-dependent development."City officials have also noted their concern over certain elements of the project's draft environmental impact report, such as the university's analysis of how the project will affect traffic patterns in Mission Valley. The council must approve a final version of the report prior to completing the sale.On Monday, the Friends of SDSU, a group of university alumni and community members, called on the city to accept the appraisal without changes, arguing that the project would be transformative for the city and SDSU will be a good steward in overseeing the land."Introduction of extraneous considerations that are inconsistent with the provisions of voter-approved Measure G or are outside the mutually agreed-to guidelines for the appraisal could substantially delay or threaten altogether the successful transfer of this property," Friends of SDSU wrote in a letter to Mayor Kevin Faulconer and the council.San Diego voters approved the plan, then known as SDSU West and now dubbed SDSU Mission Valley, last November. Since then, the university has selected two firms to oversee the planning and construction of the future stadium and campus while negotiating the sale with the city.On the project's current timeline, university officials expect the California State University Board of Trustees to consider approving a draft environmental impact report on the SDSU West plan early next year. The university expects to break ground on the project in early 2020 and complete the redevelopment in its entirety by the mid-2030s. 3022