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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 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) - San Diego County public health officials have reported 443 new COVID-19 cases and three additional deaths from the illness, raising the county's cumulative tally to 40,342 cases and 704 fatalities.Two women and a man died between July 29 and Sept 3. Their ages ranged from early 70s to early 80s. All three had underlying medical conditions.San Diego County's state-calculated case rate is 5.8 and the testing positivity percentage is 3.8%.Of 7,445 tests reported Friday, 6% returned positive, raising the county's 14-day rolling positive testing rate to 4.2%, well below the state's 8% guideline. The seven-day average number of tests performed in the county is 7,102.Of the total positive cases in the county, 3,199 -- or 7.9% -- have required hospitalization since the pandemic began, and 768 -- or 1.9% -- were admitted to an intensive care unit.County health officials reported four new community outbreaks Friday, bringing the number of outbreaks in the past week to 20. One of the outbreaks was in a government setting, two in restaurants and one in a hotel/resort/spa setting.The number of community outbreaks remains well above the county's goal of fewer than seven in a seven-day span. A community setting outbreak is defined as three or more COVID-19 cases in a setting and in people of different households in the past 14 days.San Diego State University reported another 120 confirmed or probable COVID-19 cases among its student population Friday, raising the university's total caseload to 184 since fall semester began Aug. 24.On Saturday, SDSU issued a stay-at-home order for students living in on-campus residence halls, asking them to stay in their current residences except for essential needs throughout the weekend as the school battles an outbreak of the coronavirus.The order goes into effect at 10 p.m. Saturday through 6 a.m. Tuesday."Students should stay in their current residences, except to take care of essential needs, including medical care, accessing meals, shopping for necessities such as food/meals and medical supplies, exercising outdoors (with facial coverings), and traveling for the purposes of work," a statement from SDSU read.Violations of the order may result in disciplinary consequences, the college said.Additionally, San Diego County public health officials confirmed multiple clusters of COVID-19 cases within the university community among students. This includes the previously announced off-campus outbreak on Wednesday. SDSU officials say none of the cases under investigation are related to on-campus educational activities, including classes or labs.Luke Wood, SDSU's vice president for student affairs and campus diversity, said the university was working with a security company to enforce public health code violations and had issued a total of 457 student violations through Friday afternoon. Wood said the most serious of these violations could result in suspension or expulsion from the university. Some organizations have been cited as well. Wood said the majority of these were fraternities or sororities, but followed up that not all were, and outbreaks impact the community at large regardless of the type of group they occurred in.All of the university's in-person classes -- which SDSU President Adela de la Torre said comprised just 7% of all courses -- were moved online Wednesday. SDSU also paused all on-campus athletics training and workouts for two weeks starting Thursday due to COVID-19."Only a small fraction of students have met in person," de la Torre said. SDSU has a student body of more than 35,000. Nearly 8,000 students live on campus.She cautioned that "testing alone and testing once" would not be enough, and a robust system to enforce health orders would continue to be needed to avoid the "plague of parties" already present near campus.SDSU has more than 130 spaces for students to safely quarantine, according to the university, and all students who have moved into campus housing would be able to move out if they so choose.County health officials warned that Labor Day weekend could be a spreading event for COVID-19."Most people won't be working over the long holiday period, but COVID- 19 will not be taking the day off," said Dr. Wilma Wooten, county public health officer. "The more people go out and the more they interact with people outside their household, the more likely they are to contract the virus." 4432

SAN DIEGO (CNS) - Poll watchers will be permitted to observe election activities at polling stations countywide on Nov. 3, though COVID-19 related restrictions will limit the number of people allowed inside polling places.Social distancing requirements mean only about one to two observers might be rotated in and out of the polling places at any given time this year, Assistant Registrar of Voters Cynthia Paes said Thursday.The number of polling places in San Diego County has been reduced from 1,548 in March to 235 larger polling places that will be open for four days and are each expected to be staffed by about 15 county employees, Paes said.The role of poll watchers has garnered increased attention as part of the national discussion on voter fraud and voter intimidation sparked most recently by President Donald Trump's call at Tuesday's presidential debate for his supporters to monitor polling places on Election Day.Trump, who has frequently raised the specter of voter fraud and publicly expressed doubts over the security of mail-in voting, urged supporters Tuesday to "go into the polls and watch very carefully because that's what has to happen."Tony Krvaric, chair of the San Diego County Republican Party, said recruiting poll watchers is a typical practice, intended to ensure votes are cast and note any irregularities in the voting process."We always recruit for poll watchers and have done so for as long as I can remember," Krvaric told City News Service."Poll watchers help make sure Republicans who haven't voted are contacted and reminded to do so and keep an eye out for any irregularities. This is nothing new. Democrats presumably do the same."Krvaric said any such instances of irregularities are reported to local officials or the Registrar of Voters."Any voter irregularities could dilute legitimate votes cast," he said.Will Rodriguez-Kennedy, chair of the San Diego County Democratic Party, said he was confident in the San Diego County Registrar of Voters' ability to ensure a fair election process, saying there are "a number of processes (conducted) to verify a vote."Regarding Trump's allegations of voter fraud related to mail-in voting, Rodriguez-Kennedy called Trump's assertions "a falsehood," based largely in myth.Rodriguez-Kennedy told City News Service "mail ballot voting is safe and secure" and said its presence this election will increase overall voter turnout, something he said represented "a problem for this president."Of Trump's statements at the debate, he said his "intent is to sow discontent because he fears he is losing." 2592

SAN DIEGO (CNS) - San Diego County health officials have reported 558 new COVID-19 cases and no new deaths, raising the region's totals to 19,929 cases and the death count remaining at 422.Of the 8,505 tests reported Saturday, 7% were positive new cases. The 14-day rolling average for positive tests is 6.1%. The target is less than 8%. The 7-day daily average of tests is 7,853.Of the total positive cases, 2,036 or 10.2% have been hospitalized and 535 or 2.7% of cases have been admitted to an intensive care unit.Two new community outbreaks, one in a healthcare setting and the other in a restaurant-bar, were reported Saturday, bringing the total over the past week to 18, more than double the trigger of seven or more in seven days. A community setting outbreak is defined as three or more COVID-19 cases in a setting and people from different households.More than 75% of the community outbreaks have been traced to restaurants and bars, and 45 community outbreaks remain active, tied to 137 cases of COVID-19 as of Wednesday's data.An additional 23 outbreaks have been traced to skilled nursing facilities and 27 to other nursing facilities.A record-high 578 cases, a 10% positive test rate and 12 deaths were reported Tuesday.A new daily high of 38 COVID-19 positive patients were hospitalized in Wednesday's data, and about 136 of every 100,000 San Diegans are testing positive for the illness, well above the state's criterion of 100 per 100,000. Total COVID-19 hospitalizations have inched up over the last several weeks, said Dr. Wilma Wooten, the county's public health officer."The pandemic is not over," Wooten reminded county residents last week. "The disease is still widespread in our community, as evidenced by the rising cases."Despite the numbers, some local leaders believe San Diego County should have the authority to open its businesses. County supervisors Kristin Gaspar and Jim Desmond and San Diego City Councilman Chris Cate sent a letter to Gov. Gavin Newsom Wednesday evening, asking the governor to rescind orders to shutter indoor business in multiple industries -- including bars, restaurants, museums, cardrooms, zoos and theaters."This statewide one-size-fits-all approach to closing entire business sectors is misguided as evidenced by the many sectors in San Diego forced to close their doors again despite not having contributed at all to the rise in our local cases. As such, we are requesting the review of our county's data to take place as soon as possible, thereby allowing San Diego businesses to reopen if appropriate," they wrote in the joint letter."It is time to give local control of this public health emergency to the elected leaders and clinical team closest to the people so that we can begin community specific healing based on local data. We are confident that San Diego County is well-positioned to serve as a model in this effort," the letter said. 2914