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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) - The aircraft carrier USS Nimitz and elements of the Nimitz Carrier Strike Group deployed from San Diego Monday in support of global maritime security operations, Navy officials announced.Prior to departing, the strike group completed a composite training unit exercise called COMPTUEX, which is designed to fully integrate units of a carrier strike group while testing its ability as a whole to carry out sustained combat operations from the sea.Ships, squadrons and staffs have been tested across every core warfare area within their mission sets through a variety of simulated and live events, including air warfare, strait transits, and responses to surface and subsurface contacts and electronic attacks, according to U.S. Third Fleet public affairs."The carrier strike group team is trained and ready," said Rear Adm. Jim Kirk, commander of the strike group. "The men and women of Carrier Strike Group 11 have demonstrated exceptional tactical and technical expertise, teamwork and toughness. We are honored to answer the call and operate forward."In addition to conducting maritime security operations whenever and wherever called upon, strike-group units will participate in cooperative engagements, multilateral exercises and unit-level training designed to improve capability and capacity among Navy units and partner nations in the regions they may operate in.All personnel assigned to the group completed a minimum 14-day quarantine ashore and were tested for COVID-19 prior to getting underway with their respective units. Sailors assigned to Nimitz completed a 27-day fast cruise aboard the ship which also included their testing period for the virus.In addition to the Nimitz, deploying units include Carrier Air Wing 17, Ticonderoga-class guided-missile cruiser USS Princeton and Destroyer Squadron 9, which includes Arleigh Burke-class guided-missile destroyers USS Sterett and USS Ralph Johnson.Sterett departed Naval Base San Diego on Thursday, Princeton steamed out on Saturday and Ralph Johnson is scheduled to leave Tuesday, according to the Navy. 2094

SAN DIEGO (CNS) - San Diego County health officials have reported a record 736 new COVID-19 cases Saturday and five more deaths as nonessential businesses moved to outdoor-only when the county went from the red to the purple tier of the state's four-tiered coronavirus reopening plan.The data increases the total caseload since the start of the pandemic to 63,681, with the death toll rising to 926. This is the fourth consecutive day that more than 600 new coronavirus cases were reported by the county.On Wednesday, a record 661 COVID-19 cases were reported in the county - - surpassing the 652 cases reported Aug. 7. Another 620 cases were reported Thursday."We have not seen cases this high in months, and it's a clear indication that COVID-19 is widespread," said Dr. Wilma Wooten, the county's public health officer."These totals also show people are not following the public health recommendations that we know work to prevent getting and passing COVID-19."Wooten added that in the weeks following Halloween, this record case jump is a warning sign people "need to follow public health guidance throughout the upcoming holiday season."This comes as state data has landed the county in the most restrictive tier of the state's COVID-19 reopening plan. The restrictions associated with the purple tier went into effect just after midnight Saturday.Many nonessential businesses are now required to move to outdoor-only operations. These include restaurants, family entertainment centers, wineries, places of worship, movie theaters, museums, gyms, zoos, aquariums and cardrooms.The restrictions include closing amusement parks. Bars, breweries and distilleries will be able to remain open as long as they are able to operate outside and with food on the same ticket as alcohol.Retail businesses and shopping centers can remain open with 25% of the building's capacity. No food courts will be permitted.Schools will be able to remain open for in-person learning if they are already in session. If a district has not reopened for in-person learning, it must remain remote only. Offices are restricted to remote work.Remaining open are essential services, personal care services, barbershops, hair salons, outdoor playgrounds and recreational facilities.The county's demotion from the less-restrictive red tier is the result of two weeks of case rates that exceeded the threshold of 7 per 100,000 residents.In recent weeks, the region had an unadjusted rate well above the purple tier guidelines, but a significant effort to increase the volume of tests had allowed for an adjustment to bring it back to the red, or substantial, tier.State officials reported Tuesday that San Diego County had an unadjusted new daily coronavirus case rate of 10.0 per 100,000. The adjusted case rate dropped to 8.9 per 100,000. Last week's unadjusted case rate was 8.7 per 100,000.According to the reopening plan, a county has to report data exceeding a more restrictive tier's guidelines for two consecutive weeks before being moved to that tier. A county then has to be in that tier for a minimum of three weeks before it may move to a less restrictive tier.Even as the number of cases continues to climb, the testing positivity rate for the region continues to decline. From last week's data, it dropped to 2.6%, a 0.8% decline. It still remains high enough for this metric to remain in the orange tier.The state's health equity metric, which looks at the testing positivity for areas with the least healthy conditions, increased from 5.3% to 6.5% and remained in the red tier. This metric does not move counties backward to more restrictive tiers, but is required to advance.Of the 14,663 tests reported Friday, 4% returned positive, increasing the 14-day rolling average of positive tests to 3.8%.Of the total number of cases in the county, 4,154 -- or 6.6% -- have required hospitalization and 947 patients -- or 1.5% of all cases -- had to be admitted to an intensive care unit.Four community outbreaks were reported Friday. The number of community outbreaks in the past week increased to 48.The county launched a COVID-19 case rate map Thursday showing how cities and communities are being impacted by the novel coronavirus. The interactive map allows users to identify the case rate per 100,000 residents in cities and communities or by ZIP codes.The map also shows where each area falls under the different state tiers and whether their case rate and testing positivity are going up or down. The map can be found at: sdcounty.maps.arcgis.com/apps/opsdashboard/index.html#/e09887e8e65d4fda847aa04c 480dc73f. 4608

SAN DIEGO (CNS) - The mercury could climb into the triple digits Thursday in the San Diego County mountains and foothills as a stretch of scorching heat begins in Southern California.A ridge of high pressure will continue building over the southwestern United States through Monday, ushering in the scorching heat, according to the National Weather Service.The NWS issued an excessive heat warning that will be in effect from noon Friday to 9 p.m. Monday in the county valleys, mountains and deserts.LATEST 10NEWS PINPOINT WEATHER FORECASTThe NWS urged residents to drink plenty of fluids, stay out of the sun and check up on relatives and neighbors. Also, young children and pets should be never be left unattended in a vehicle, with car interiors able to "reach lethal temperatures in a matter of minutes," according to the NWS.Highs in the county deserts could climb to 118 on Friday, then 119 from Sunday through Wednesday, according to the NWS. The mercury in the western valleys is forecast to top out at 95 on Friday, while highs near the foothills could hit 102 on Friday and 101 on Saturday.High temperatures Thursday are forecast to reach 82 degrees near the coast, 90 inland, 93 in the western valleys, 99 near the foothills, 100 in the mountains and 117 in the deserts. 1289

SAN DIEGO (CNS) -- San Diego lifeguards and firefighters Sunday rescued a surfer who suffered a medical emergency while in the water in the Bird Rock area, authorities said.At 12:36 p.m., lifeguards and firefighters from the San Diego Fire- Rescue Department responded to the cliffs near Calumet Park about a surfer experiencing an unknown medical emergency, Lt. Andy Lerum of Lifeguard Services said.The man in his 60s experienced a possible heart-related ailment or seizure, but rescuers were not sure of the exact nature of his medical emergency, Lerum said.The man swam to the beach, where he collapsed and lifeguards began tending to him, the lieutenant said. He was taken by stretcher about 30 yards to the bottom of the cliff.Firefighters used the department's Rescue 44 truck, equipped with a crane, to lift the surfer from the beach to the top of the cliff, Lerum said. An ambulance then took the man to a La Jolla hospital for evaluation. He was reportedly in stable condition. 995

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