All posts by aclasuperadmin
ACLA Comments ONC NPRM
Commercial Labs Step Up Capacity, Collaborate With Public Health Partners To Respond To National Emergency
Commercial capacity is expected to exceed 20,000 tests per day nationwide by end of next week, 280,000 tests per week by April 1.
WASHINGTON, D.C. – Commercial laboratories have stepped up to bring critical COVID-19 testing capacity to the U.S. health care system. Following the FDA’s guidance on February 29 that provided an accelerated path for commercial laboratories to perform COVID-19 testing, commercial laboratories introduced high-throughput Laboratory Developed Tests (LDTs) to significantly expand testing capabilities across the country, with the current capacity of processing several thousand tests a day.
Once additional FDA-approved high-throughput testing is available on large diagnostic platforms next week, the industry expects its capacity to be increased to more than 20,000 tests per day. Assuming there are no delays or shortages of necessary materials and supplies, commercial capacity is expected to exceed 280,000 tests per week by April 1.
“This national emergency means commercial labs are being asked to step up in unprecedented ways, and we are answering that call,” said Julie Khani, president of ACLA. “We are committed to supporting our public health partners and rapid response efforts and will remain in constant communication with HHS and the Administration about our response, the obstacles we face, and other information as the situation evolves.”
ACLA members, including ARUP, BioReference Laboratories, LabCorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare are currently working on scaling up capacity and are part of a newly-formed consortium working together with the Administration, the CDC and FDA as well as state and local public health labs, hospitals and academic medical centers.
ACLA has worked closely with the CDC and other federal agencies to help anticipate any potential shortages laboratories may face down the line. As a part of this ongoing communication with federal agencies, ACLA has raised concerns about potential shortages of certain supplies that may affect testing capacity, including specimen collection swabs, N95 respirators, viral transport media, masks, gloves, and hand sanitizer.
“The Administration and HHS are supportive of our expanded efforts,” said Khani. “We’ll continue our real time communication to ensure we are being proactive in response to any supply chain issues.”
#
ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.
COVID-19 Response Efforts: Role of Clinical Laboratories
Last Updated March 2023
Recent Updates
- Letter (March 21, 2022): COVID Relief Funding Letter
- Blog (March 1, 2022): An Emerging Crisis of Undiagnosed Diseases and Delayed Treatment
- Blog (February 22, 2022): Clinical Labs’ Role in Identifying and Sequencing Variants During the COVID-19 Pandemic
- Statement (January 12, 2022): ACLA Statement on COVID-19 Testing Capacity and Turnaround Time
- Statement (November 15): ACLA Statement on Changes to LDT Regulation and Review
- Statement (November 4): ACLA Statement on Release of OSHA and CMS Rules
- Statement (September 9): ACLA Statement on President Biden’s New COVID-19 Testing Plan
- Letter (September 1): ACLA, AdvaMedDx Letter to COVID-19 Response Team
- Resource (June 25): Declines in Routine Testing Fact Sheet
- Statement (May 25): ACLA Applauds New Investments in COVID-19 Testing for the Uninsured
- Letter (May 21): ACLA Letter to Secretary Becerra on the Regulation of Laboratory Developed Tests (LDTs)
- LinkedIn Article (May 7): Labs and Public Health: A Critical Partnership During the Pandemic, and Beyond
- Letter (April 28): ACLA 100 Days Letter to President Biden
- White Paper (April 22): ACLA White Paper: Considerations for Appropriate Use of SARS-CoV-2 Testing
- Statement (March 18): ACLA Statement on Recent Steps to Expand Testing
- Statement (February 26): ACLA Statement on President Biden’s Actions to Close Coverage Gaps for COVID-19 Testing
- Letter (February 23): ACLA Letter To Senate Finance Committee On Xavier Becerra’s Nomination
- Letter (February 22): ACLA Letter To Biden Administration On COVID Testing
- Press Release (February 6): ACLA Member Labs Surpass 100 Million COVID-19 Tests Performed
- Statement (January 21): ACLA Statement on President Biden’s Actions to Combat COVID-19
- Letter (January 21): Joint Letter on Cycle-Threshold Value Reporting
- Resource (January 15): Impact of Variant Mutations on COVID-19 Testing
- Statement (January 14): ACLA Statement on President-elect Biden’s American Rescue Plan
- LinkedIn Article (December 23): 2021: What’s Next?
- Statement (December 21): ACLA Statement on Year-End Funding Package
- Blog (December 21): Multiplex Testing: An Important Tool to Counter the Spread of Flu and COVID-19
- Statement (December 15): ACLA Statement on COVID-19 Vaccine Approval
COVID-19 Tests Performed By ACLA Members
Molecular PCR tests performed by ACLA members
The below data set contains a snapshot of daily tests performed by ACLA member laboratories from March 2020 through May 2021. For updated statistics, please visit the CDC’s COVID Data Tracker.
| Date | Approximate Tests Performed | Approximate Total Tests to Date |
|---|---|---|
| May 27, 2021 | 170,000 | 125,397,000 |
| May 26, 2021 | 183,000 | 125,227,000 |
| May 25, 2021 | 188,000 | 125,044,000 |
| May 24, 2021 | 85,000 | 124,856,000 |
| May 23, 2021 | 85,000 | 124,772,000 |
| May 22, 2021 | 159,000 | 124,686,000 |
| May 21, 2021 | 179,000 | 124,532,000 |
| May 20, 2021 | 197,000 | 124,354,000 |
| May 19, 2021 | 218,000 | 124,168,000 |
| May 18, 2021 | 215,000 | 123,945,000 |
| May 17, 2021 | 93,000 | 123,736,000 |
| May 16, 2021 | 99,000 | 123,652,000 |
| May 15, 2021 | 185,000 | 123,552,000 |
| May 14, 2021 | 195,000 | 123,366,000 |
| May 13, 2021 | 218,000 | 123,171,000 |
| May 12, 2021 | 240,000 | 123,179,000 |
| May 11, 2021 | 231,000 | 122,939,000 |
| May 10, 2021 | 100,000 | 122,709,000 |
| May 9, 2021 | 111,000 | 122,610,000 |
| May 8, 2021 | 188,000 | 122,496,000 |
| May 7, 2021 | 216,000 | 122,309,000 |
| May 6, 2021 | 236,000 | 122,095,000 |
| May 5, 2021 | 264,000 | 121,859,000 |
| May 4, 2021 | 249,000 | 121,595,000 |
| May 3, 2021 | 106,000 | 121,345,000 |
| May 2, 2021 | 114,000 | 121,243,000 |
| May 1, 2021 | 216,000 | 121,129,000 |
| April 30, 2021 | 228,000 | 120,913,000 |
| April 29, 2021 | 260,000 | 120,685,000 |
| April 28, 2021 | 276,000 | 120,416,000 |
| April 27, 2021 | 260,000 | 120,140,000 |
| April 26, 2021 | 113,000 | 119,880,000 |
| April 25, 2021 | 131,000 | 119,771,000 |
| April 24, 2021 | 233,000 | 119,639,000 |
| April 23, 2021 | 249,000 | 119,408,000 |
| April 22, 2021 | 258,000 | 119,158,000 |
| April 21, 2021 | 298,000 | 118,900,000 |
| April 20, 2021 | 274,000 | 118,601,000 |
| April 19, 2021 | 121,000 | 118,326,000 |
| April 18, 2021 | 144,000 | 118,205,000 |
| April 17, 2021 | 241,000 | 118,061,000 |
| April 16, 2021 | 257,000 | 117,819,000 |
| April 15, 2021 | 282,000 | 117,546,000 |
| April 14, 2021 | 310,000 | 117,264,000 |
| April 13, 2021 | 260,000 | 116,954,000 |
| April 12, 2021 | 125,000 | 116,694,000 |
| April 11, 2021 | 150,000 | 116,565,000 |
| April 10, 2021 | 243,000 | 116,415,000 |
| April 9, 2021 | 260,000 | 116,172,000 |
| April 8, 2021 | 292,000 | 115,921,000 |
| April 7, 2021 | 311,000 | 115,629,000 |
| April 6, 2021 | 265,000 | 115,318,000 |
| April 5, 2021 | 119,000 | 115,052,000 |
| April 4, 2021 | 150,000 | 114,938,000 |
| April 3, 2021 | 237,000 | 114,787,000 |
| April 2, 2021 | 263,000 | 114,551,000 |
| April 1, 2021 | 286,000 | 114,288,000 |
| March 31, 2021 | 303,000 | 114,005,000 |
| March 30, 2021 | 274,000 | 113,702,000 |
| March 29, 2021 | 134,000 | 113,429,000 |
| March 28, 2021 | 152,000 | 113,297,000 |
| March 27, 2021 | 251,000 | 113,146,000 |
| March 26, 2021 | 271,000 | 112,895,000 |
| March 25, 2021 | 285,000 | 112,622,000 |
| March 24, 2021 | 305,000 | 112,321,000 |
| March 23, 2021 | 273,000 | 112,016,000 |
| March 22, 2021 | 130,000 | 111,743,000 |
| March 21, 2021 | 145,000 | 111,613,000 |
| March 20, 2021 | 240,000 | 111,467,000 |
| March 19, 2021 | 262,000 | 111,226,000 |
| March 18, 2021 | 292,000 | 110,964,000 |
| March 17, 2021 | 311,000 | 110,675,000 |
| March 16, 2021 | 267,000 | 110,365,000 |
| March 15, 2021 | 130,000 | 110,098,000 |
| March 14, 2021 | 165,000 | 109,970,000 |
| March 13, 2021 | 237,000 | 109,805,000 |
| March 12, 2021 | 267,000 | 109,570,000 |
| March 11, 2021 | 285,000 | 109,302,000 |
| March 10, 2021 | 332,000 | 109,032,000 |
| March 9, 2021 | 294,000 | 108,701,000 |
| March 8, 2021 | 131,000 | 108,411,000 |
| March 7, 2021 | 147,000 | 108,280,000 |
| March 6, 2021 | 260,000 | 108,133,000 |
| March 5, 2021 | 283,000 | 107,874,000 |
| March 4, 2021 | 312,000 | 107,591,000 |
| March 3, 2021 | 291,000 | 107,279,000 |
| March 2, 2021 | 296,000 | 106,989,000 |
| March 1, 2021 | 143,000 | 106,692,000 |
| February 28, 2021 | 160,000 | 106,529,000 |
| February 27, 2021 | 278,000 | 106,367,000 |
| February 26, 2021 | 302,000 | 106,089,000 |
| February 25, 2021 | 337,000 | 105,787,000 |
| February 24, 2021 | 385,000 | 105,446,000 |
| February 23, 2021 | 321,000 | 105,061,000 |
| February 22, 2021 | 162,000 | 104,739,000 |
| February 21, 2021 | 182,000 | 104,591,000 |
| February 20, 2021 | 267,000 | 104,405,000 |
| February 19, 2021 | 266,000 | 104,138,000 |
| February 18, 2021 | 283,000 | 103,872,000 |
| February 17, 2021 | 293,000 | 103,607,000 |
| February 16, 2021 | 224,000 | 103,313,000 |
| February 15, 2021 | 157,000 | 103,089,000 |
| February 14, 2021 | 175,000 | 102,932,000 |
| February 13, 2021 | 298,000 | 102,756,000 |
| February 12, 2021 | 334,000 | 102,458,000 |
| February 11, 2021 | 382,000 | 102,124,000 |
| February 10, 2021 | 394,000 | 101,751,000 |
| February 9, 2021 | 355,000 | 101,358,000 |
| February 8, 2021 | 167,000 | 101,003,000 |
| February 7, 2021 | 231,000 | 100,851,000 |
| February 6, 2021 | 363,000 | 100,618,000 |
| February 5, 2021 | 399,000 | 100,255,000 |
| February 4, 2021 | 423,000 | 99,864,000 |
| February 3, 2021 | 420,000 | 99,440,000 |
| February 2, 2021 | 325,000 | 99,020,000 |
| February 1, 2021 | 171,000 | 98,695,000 |
| January 31, 2021 | 268,000 | 98,527,000 |
| January 30, 2021 | 393,000 | 98,257,000 |
| January 29, 2021 | 431,000 | 97,864,000 |
| January 28, 2021 | 475,000 | 97,433,000 |
| January 27, 2021 | 521,000 | 96,957,000 |
| January 26, 2021 | 382,000 | 96,437,000 |
| January 25, 2021 | 235,000 | 96,055,000 |
| January 24, 2021 | 342,000 | 95,829,000 |
| January 23, 2021 | 445,000 | 95,486,000 |
| January 22, 2021 | 476,000 | 95,041,000 |
| January 21, 2021 | 509,000 | 94,573,000 |
| January 20, 2021 | 515,000 | 94,064,000 |
| January 19, 2021 | 410,000 | 93,550,000 |
| January 18, 2021 | 233,000 | 93,140,000 |
| January 17, 2021 | 361,000 | 92,915,000 |
| January 16, 2021 | 488,000 | 92,554,000 |
| January 15, 2021 | 539,000 | 92,066,000 |
| January 14, 2021 | 580,000 | 91,527,000 |
| January 13, 2021 | 587,000 | 90,947,000 |
| January 12, 2021 | 467,000 | 90,360,000 |
| January 11, 2021 | 317,000 | 89,893,000 |
| January 10, 2021 | 431,000 | 89,553,000 |
| January 9, 2021 | 526,000 | 89,122,000 |
| January 8, 2021 | 583,000 | 88,595,000 |
| January 7, 2021 | 601,000 | 88,067,000 |
| January 6, 2021 | 594,000 | 87,465,000 |
| January 5, 2021 | 445,000 | 86,872,000 |
| January 4, 2021 | 300,000 | 86,427,000 |
| January 3, 2021 | 294,000 | 86,129,000 |
| January 2, 2021 | 333,000 | 85,833,000 |
| January 1, 2021 | 471,000 | 85,500,000 |
| December 31, 2020 | 557,000 | 85,029,000 |
| December 30, 2020 | 582,000 | 84,472,000 |
| December 29, 2020 | 424,000 | 83,891,000 |
| December 28, 2020 | 243,000 | 83,467,000 |
| December 27, 2020 | 293,000 | 83,236,000 |
| December 26, 2020 | 300,000 | 82,950,000 |
| December 25, 2020 | 479,000 | 82,650,000 |
| December 24, 2020 | 580,000 | 82,190,000 |
| December 23, 2020 | 588,000 | 81,610,000 |
| December 22, 2020 | 460,000 | 81,021,000 |
| December 21, 2020 | 360,000 | 80,561,000 |
| December 20, 2020 | 442,000 | 80,215,000 |
| December 19, 2020 | 538,000 | 79,783,000 |
| December 18, 2020 | 555,000 | 79,245,000 |
| December 17, 2020 | 551,000 | 78,690,000 |
| December 16, 2020 | 560,000 | 78,140,000 |
| December 15, 2020 | 461,000 | 77,580,000 |
| December 14, 2020 | 338,000 | 77,120,000 |
| December 13, 2020 | 476,000 | 76,786,000 |
| December 12, 2020 | 556,000 | 76,310,000 |
| December 11, 2020 | 568,000 | 75,754,000 |
| December 10, 2020 | 592,000 | 75,186,000 |
| December 9, 2020 | 559,000 | 74,594,000 |
| December 8, 2020 | 454,000 | 74,035,000 |
| December 7, 2020 | 385,000 | 73,581,000 |
| December 6, 2020 | 458,000 | 73,196,000 |
| December 5, 2020 | 547,000 | 72,737,000 |
| December 4, 2020 | 555,000 | 72,191,000 |
| December 3, 2020 | 570,000 | 71,646,000 |
| December 2, 2020 | 556,000 | 71,076,000 |
| December 1, 2020 | 416,000 | 70,519,000 |
| November 30, 2020 | 313,000 | 70,103,000 |
| November 29, 2020 | 400,000 | 69,790,000 |
| November 28, 2020 | 461,000 | 69,390,000 |
| November 27, 2020 | 485,000 | 68,951,000 |
| November 26, 2020 | 550,000 | 68,466,000 |
| November 25, 2020 | 603,000 | 67,916,000 |
| November 24, 2020 | 515,000 | 67,313,000 |
| November 23, 2020 | 460,000 | 66,780,000 |
| November 22, 2020 | 514,000 | 66,337,000 |
| November 21, 2020 | 561,000 | 65,823,000 |
| November 20, 2020 | 547,000 | 65,262,000 |
| November 19, 2020 | 577,000 | 64,707,000 |
| November 18, 2020 | 545,000 | 64,129,000 |
| November 17, 2020 | 500,000 | 63,585,000 |
| November 16, 2020 | 378,000 | 63,084,000 |
| November 15, 2020 | 445,000 | 62,706,000 |
| November 14, 2020 | 490,000 | 62,261,000 |
| November 13, 2020 | 486,000 | 61,772,000 |
| November 12, 2020 | 500,000 | 61,267,000 |
| November 11, 2020 | 495,000 | 60,767,000 |
| November 10, 2020 | 377,000 | 60,271,000 |
| November 9, 2020 | 320,000 | 59,895,000 |
| November 8, 2020 | 386,000 | 59,575,000 |
| November 7, 2020 | 474,000 | 59,189,000 |
| November 6, 2020 | 444,000 | 58,714,000 |
| November 5, 2020 | 456,000 | 58,261,000 |
| November 4, 2020 | 442,000 | 57,805,000 |
| November 3, 2020 | 350,000 | 57,363,000 |
| November 2, 2020 | 289,000 | 57,013,000 |
| November 1, 2020 | 361,000 | 56,724,000 |
| October 31, 2020 | 399,000 | 56,364,000 |
| October 30, 2020 | 359,000 | 55,965,000 |
| October 29, 2020 | 424,000 | 55,599,000 |
| October 28, 2020 | 419,000 | 55,175,000 |
| October 27, 2020 | 326,000 | 54,755,000 |
| October 26, 2020 | 258,000 | 54,429,000 |
| October 25, 2020 | 323,000 | 54,170,000 |
| October 24, 2020 | 407,000 | 53,834,000 |
| October 23, 2020 | 419,000 | 53,427,000 |
| October 22, 2020 | 400,000 | 53,008,000 |
| October 21, 2020 | 397,000 | 52,608,000 |
| October 20, 2020 | 296,000 | 52,211,000 |
| October 19, 2020 | 202,000 | 51,915,000 |
| October 18, 2020 | 316,000 | 51,712,000 |
| October 17, 2020 | 385,000 | 51,395,000 |
| October 16, 2020 | 367,000 | 51,010,000 |
| October 15, 2020 | 407,000 | 50,651,000 |
| October 14, 2020 | 375,000 | 50,244,000 |
| October 13, 2020 | 309,000 | 49,869,000 |
| October 12, 2020 | 248,000 | 49,560,000 |
| October 11, 2020 | 330,000 | 49,312,000 |
| October 10, 2020 | 381,000 | 48,983,000 |
| October 9, 2020 | 397,000 | 48,603,000 |
| October 8, 2020 | 406,000 | 48,203,000 |
| October 7, 2020 | 399,000 | 47,797,000 |
| October 6, 2020 | 284,000 | 47,398,000 |
| October 5, 2020 | 195,000 | 47,114,000 |
| October 4, 2020 | 259,000 | 46,913,000 |
| October 3, 2020 | 330,000 | 46,651,000 |
| October 2, 2020 | 344,000 | 46,322,000 |
| October 1, 2020 | 381,000 | 45,979,000 |
| September 30, 2020 | 363,000 | 45,598,000 |
| September 29, 2020 | 268,000 | 45,235,000 |
| September 28, 2020 | 178,000 | 44,967,000 |
| September 27, 2020 | 244,000 | 44,789,000 |
| September 26, 2020 | 337,000 | 44,540,000 |
| September 25, 2020 | 361,000 | 44,203,000 |
| September 24, 2020 | 357,000 | 43,842,000 |
| September 23, 2020 | 348,000 | 43,485,000 |
| September 22, 2020 | 253,000 | 43,137,000 |
| September 21, 2020 | 156,000 | 42,884,000 |
| September 20, 2020 | 253,000 | 42,723,000 |
| September 19, 2020 | 326,000 | 42,475,000 |
| September 18, 2020 | 350,000 | 42,149,000 |
| September 17, 2020 | 338,000 | 41,772,000 |
| September 16, 2020 | 326,000 | 41,434,000 |
| September 15, 2020 | 236,000 | 41,108,000 |
| September 14, 2020 | 167,000 | 40,872,000 |
| September 13, 2020 | 256,000 | 40,705,000 |
| September 12, 2020 | 311,000 | 40,450,000 |
| September 11, 2020 | 300,000 | 40,139,000 |
| September 10, 2020 | 331,000 | 39,847,000 |
| September 9, 2020 | 242,000 | 39,516,000 |
| September 8, 2020 | 141,000 | 39,274,000 |
| September 7, 2020 | 144,000 | 39,133,000 |
| September 6, 2020 | 235,000 | 38,986,000 |
| September 5, 2020 | 283,000 | 38,751,000 |
| September 4, 2020 | 317,000 | 38,468,000 |
| September 3, 2020 | 331,000 | 38,151,000 |
| September 2, 2020 | 305,000 | 37,820,000 |
| September 1, 2020 | 232,000 | 37,515,000 |
| August 31, 2020 | 177,000 | 37,283,000 |
| August 30, 2020 | 256,000 | 37,106,000 |
| August 29, 2020 | 318,000 | 36,850,000 |
| August 28, 2020 | 334,000 | 36,531,000 |
| August 27, 2020 | 330,000 | 36,191,000 |
| August 26, 2020 | 324,000 | 35,862,000 |
| August 25, 2020 | 246,000 | 35,538,000 |
| August 24, 2020 | 180,000 | 35,291,000 |
| August 23, 2020 | 244,000 | 35,111,000 |
| August 22, 2020 | 329,000 | 34,867,000 |
| August 21, 2020 | 333,000 | 34,538,000 |
| August 20, 2020 | 369,000 | 34,204,000 |
| August 19, 2020 | 348,000 | 33,835,000 |
| August 18, 2020 | 255,000 | 33,487,000 |
| August 17, 2020 | 206,000 | 33,232,000 |
| August 16, 2020 | 271,000 | 33,026,000 |
| August 15, 2020 | 328,000 | 32,741,000 |
| August 14, 2020 | 364,000 | 32,413,000 |
| August 13, 2020 | 369,000 | 32,049,000 |
| August 12, 2020 | 363,000 | 31,680,000 |
| August 11, 2020 | 301,000 | 31,317,000 |
| August 10, 2020 | 264,000 | 31,016,000 |
| August 9, 2020 | 319,000 | 30,752,000 |
| August 8, 2020 | 373,000 | 30,433,000 |
| August 7, 2020 | 397,000 | 30,059,000 |
| August 6, 2020 | 378,000 | 29,662,000 |
| August 5, 2020 | 388,000 | 29,295,000 |
| August 4, 2020 | 308,000 | 28,907,000 |
| August 3, 2020 | 279,000 | 28,600,000 |
| August 2, 2020 | 345,000 | 28,321,000 |
| August 1, 2020 | 383,000 | 27,971,000 |
| July 31, 2020 | 378,000 | 27,588,000 |
| July 30, 2020 | 408,000 | 27,210,000 |
| July 29, 2020 | 391,000 | 26,802,000 |
| July 28, 2020 | 349,000 | 26,411,000 |
| July 27, 2020 | 320,000 | 26,062,000 |
| July 26, 2020 | 380,000 | 25,742,000 |
| July 25, 2020 | 425,000 | 25,362,000 |
| July 24, 2020 | 419,000 | 24,925,000 |
| July 23, 2020 | 419,000 | 24,506,000 |
| July 22, 2020 | 410,000 | 24,088,000 |
| July 21, 2020 | 368,000 | 23,678,000 |
| July 20, 2020 | 341,000 | 23,309,000 |
| July 19, 2020 | 356,000 | 22,968,000 |
| July 18, 2020 | 378,000 | 22,610,000 |
| July 17, 2020 | 366,000 | 22,233,000 |
| July 16, 2020 | 369,000 | 21,868,000 |
| July 15, 2020 | 390,000 | 21,499,000 |
| July 14, 2020 | 349,000 | 21,109,000 |
| July 13, 2020 | 325,000 | 20,760,000 |
| July 12, 2020 | 323,000 | 20,434,000 |
| July 11, 2020 | 358,000 | 20,111,000 |
| July 10, 2020 | 350,000 | 19,753,000 |
| July 9, 2020 | 355,000 | 19,410,000 |
| July 8, 2020 | 349,000 | 19,055,000 |
| July 7, 2020 | 300,000 | 18,706,000 |
| July 6, 2020 | 274,000 | 18,406,000 |
| July 5, 2020 | 290,000 | 18,133,000 |
| July 4, 2020 | 351,000 | 17,843,000 |
| July 3, 2020 | 362,000 | 17,492,000 |
| July 2, 2020 | 348,000 | 17,131,000 |
| July 1, 2020 | 335,000 | 16,782,000 |
| June 30, 2020 | 307,000 | 16,447,000 |
| June 29, 2020 | 263,000 | 16,140,000 |
| June 28, 2020 | 287,000 | 15,877,000 |
| June 27, 2020 | 319,000 | 15,589,000 |
| June 26, 2020 | 332,000 | 15,270,000 |
| June 25, 2020 | 317,000 | 14,942,000 |
| June 24, 2020 | 308,000 | 14,625,000 |
| June 23, 2020 | 263,000 | 14,317,000 |
| June 22, 2020 | 219,000 | 14,054,000 |
| June 21, 2020 | 234,000 | 13,835,000 |
| June 20, 2020 | 300,000 | 13,601,000 |
| June 19, 2020 | 291,000 | 13,291,000 |
| June 18, 2020 | 295,000 | 13,000,000 |
| June 17, 2020 | 282,000 | 12,706,000 |
| June 16, 2020 | 240,000 | 12,424,000 |
| June 15, 2020 | 207,000 | 12,185,000 |
| June 14, 2020 | 229,000 | 11,978,000 |
| June 13, 2020 | 265,000 | 11,744,000 |
| June 12, 2020 | 262,000 | 11,479,000 |
| June 11, 2020 | 254,000 | 11,217,000 |
| June 10, 2020 | 255,000 | 10,962,000 |
| June 9, 2020 | 204,000 | 10,707,000 |
| June 8, 2020 | 167,000 | 10,503,000 |
| June 7, 2020 | 215,000 | 10,336,000 |
| June 6, 2020 | 229,000 | 10,121,000 |
| June 5, 2020 | 256,000 | 9,892,000 |
| June 4, 2020 | 264,000 | 9,627,000 |
| June 3, 2020 | 245,000 | 9,364,000 |
| June 2, 2020 | 214,000 | 9,199,000 |
| June 1, 2020 | 190,000 | 8,905,000 |
| May 31, 2020 | 215,000 | 8,715,000 |
| May 30, 2020 | 226,000 | 8,500,000 |
| May 29, 2020 | 238,000 | 8,274,000 |
| May 28, 2020 | 218,000 | 8,030,000 |
| May 27, 2020 | 209,000 | 7,812,000 |
| May 26, 2020 | 163,000 | 7,604,000 |
| May 25, 2020 | 179,000 | 7,441,000 |
| May 24, 2020 | 192,000 | 7,262,000 |
| May 23, 2020 | 198,000 | 7,070,000 |
| May 22, 2020 | 200,000 | 6,872,000 |
| May 21, 2020 | 203,000 | 6,672,000 |
| May 20, 2020 | 190,000 | 6,467,000 |
| May 19, 2020 | 165,000 | 6,277,000 |
| May 18, 2020 | 134,000 | 6,112,000 |
| May 17, 2020 | 159,000 | 5,978,000 |
| May 16, 2020 | 179,000 | 5,819,000 |
| May 15, 2020 | 177,000 | 5,640,000 |
| May 14, 2020 | 180,000 | 5,455,000 |
| May 13, 2020 | 163,000 | 5,275,000 |
| May 12, 2020 | 139,000 | 5,112,000 |
| May 11, 2020 | 96,000 | 4,972,000 |
| May 10, 2020 | 125,000 | 4,876,000 |
| May 9, 2020 | 142,000 | 4,752,000 |
| May 8, 2020 | 148,000 | 4,610,000 |
| May 7, 2020 | 145,000 | 4,462,000 |
| May 6, 2020 | 147,000 | 4,316,000 |
| May 5, 2020 | 121,000 | 4,170,000 |
| May 4, 2020 | 86,000 | 4,048,000 |
| May 3, 2020 | 105,000 | 3,963,000 |
| May 2, 2020 | 123,000 | 3,858,000 |
| May 1, 2020 | 130,000 | 3,735,000 |
| April 30, 2020 | 125,000 | 3,605,000 |
| April 29, 2020 | 118,000 | 3,480,000 |
| April 28, 2020 | 98,000 | 3,362,000 |
| April 27, 2020 | 66,455 | 3,264,000 |
| April 26, 2020 | 90,000 | 3,197,000 |
| April 25, 2020 | 112,000 | 3,107,000 |
| April 24, 2020 | 115,000 | 2,995,000 |
| April 23, 2020 | 109,000 | 2,880,000 |
| April 22, 2020 | 105,000 | 2,771,000 |
| April 21, 2020 | 83,000 | 2,666,000 |
| April 20, 2020 | 56,000 | 2,583,000 |
| April 19, 2020 | 68,000 | 2,527,000 |
| April 18, 2020 | 88,000 | 2,459,000 |
| April 17, 2020 | 91,000 | 2,371,000 |
| April 16, 2020 | 85,000 | 2,280,000 |
| April 15, 2020 | 76,000 | 2,195,000 |
| April 14, 2020 | 63,000 | 2,119,000 |
| April 13, 2020 | 43,000 | 2,056,000 |
| April 12, 2020 | 75,000 | 2,013,000 |
| April 11, 2020 | 91,000 | 1,937,000 |
| April 10, 2020 | 97,000 | 1,846,000 |
| April 9, 2020 | 95,000 | 1,749,000 |
| April 8, 2020 | 99,000 | 1,654,000 |
| April 7, 2020 | 75,000 | 1,555,000 |
| April 6, 2020 | 72,000 | 1,480,000 |
| April 5, 2020 | 108,000 | 1,408,000 |
| April 4, 2020 | 106,000 | 1,300,000 |
| April 3, 2020 | 101,000 | 1,194,000 |
| April 2, 2020 | 102,000 | 1,093,000 |
| April 1, 2020 | 92,000 | 992,000 |
| March 31, 2020 | 92,000 | 900,000 |
| March 30, 2020 | 75,000 | 807,000 |
| March 29, 2020 | 82,000 | 732,000 |
| March 28, 2020 | 84,000 | 650,000 |
| March 27, 2020 | 80,000 | 565,000 |
| March 26, 2020 | 80,000 | 485,000 |
| March 25, 2020 | 67,000 | 405,000 |
| March 24, 2020 | 57,000 | 338,000 |
| March 23, 2020 | 47,000 | 281,000 |
| March 22, 2020 | 51,000 | 234,000 |
| March 21, 2020 | 54,000 | 183,000 |
| March 20, 2020 | 41,000 | 129,000 |
| March 19, 2020 | 25,000 | 88,000 |
| March 18, 2020 | 20,100 | 63,000 |
| March 17, 2020 | 14,300 | 43,000 |
| March 16, 2020 | 8,200 | 27,000 |
*Daily testing totals from May 30 – June 2 have been updated to reflect additional reporting. Total tests to date were updated on December 11, 2020 to reflect additional reporting.
For the most up-to-date information on COVID-19, including proper preventative measures, please visit the Centers for Disease Control and Prevention.
#
The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.
Commercial Labs Announce Plans to Provide COVID-19 Testing
WASHINGTON, D.C. – The FDA’s latest guidance released over the weekend provided an accelerated path for high-complexity laboratories to support additional testing capacity in response to the COVID-19 outbreak.
Prior to Saturday’s announcement, ACLA members were already working to develop novel tests for COVID-19. Additionally, we have been in close communication with public health agencies since January as part of our existing memorandum of understanding with the CDC, the Association of Public Health Laboratories, and the Council of State and Territorial Epidemiologists.
Today, clinical labs are stepping up in their own capacities to meet the growing demand for national testing, even without financial assurance from the federal government. ACLA members are accelerating deployment of COVID-19 tests, and today, three ACLA members announced the availability of COVID-19 testing in the coming days.
We appreciated the opportunity to meet yesterday with Vice President Pence and the White House’s Coronavirus Task Force, and are committed to continuing our work with the Administration, the CDC and the FDA, as well as state and local public health labs, hospitals and academic medical centers to address this challenge.
ACLA Statement on the VALID Act of 2020
WASHINGTON, D.C. — Following the introduction of the Verifying Accurate Leading-edge IVCT Development Act of 2020, ACLA President Julie Khani issued the following statement:
“ACLA and our member companies are focused on responding to the growing demand for COVID-19 testing capacity. In the coming days, ACLA will be reviewing the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 with our members and engaging with stakeholders on the Hill and the broader health care community.
Over the past several years, ACLA and our members have been actively working with stakeholders to advance meaningful comprehensive diagnostic reform for patients. As we’ve consistently stated, a modernized regulatory framework must ensure sustained innovation for patients and providers and support continued access to the laboratory tools necessary for the diagnosis, monitoring and treatment of disease.
Specifically, ACLA has consistently pushed for three main priorities: 1) reform that recognizes diagnostics as separate and distinct services from medical devices as well as distinctions between LDTs and IVDs; 2) grandfather and transition policies that protect patient access to currently available laboratory tests; and 3) a regulatory system that balances the needs of innovation and appropriate regulatory oversight to ensure the accuracy, reliability and access of these tests.
We’re grateful for Representatives Diana DeGette (D-CO) and Larry Bucshon (R-IN) as well as Senators Michael Bennet (D-CO) and Richard Burr (R-NC) for their leadership and attention to this critical issue.”
#
ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.
ACLA Statement on COVID-19 Testing
Following ongoing developments related to COVID-19 testing and response, included below is a statement from ACLA President Julie Khani following today’s meeting with the White House’s Coronavirus Task Force:
“We appreciated the opportunity to meet with Vice President Pence and members of the White House’s Coronavirus Task Force this afternoon on the critical issues related to testing capacity. As an industry, clinical labs have taken steps to meet the growing demand for national testing and are working together with the Administration, the CDC and FDA as well as state and local public health labs, hospitals and academic medical centers. Currently, clinical labs are working around the clock to bring new tests online with the goal of processing several thousand tests in the coming days. In order to meet the demands for nationwide testing, ACLA and its members urge the Administration and Congress to prioritize the following critical areas:
- Expanded Emergency Use Authorizations: We urge the Administration to take immediate steps to approve emergency use authorizations (EUAs) for as many test platforms and instruments as possible in order to provide swift and accelerated access to diagnostic tests.
- Clear Testing Guidelines: We call on the CDC to provide updated guidance to providers and clinicians so that those most in need or at high-risk for COVID-19 are able to access tests as quickly as possible in light of the expanded testing criteria.
- Funding for Vital Testing Resources and Support: We urge Congress and the Administration to immediately provide funding for additional testing resources and support, including the cost associated with developing and performing tests as well as acquiring necessary supplies, including adequate testing supplies for specimen collection and protective gear for lab technicians who are working on the frontlines of specimen testing.”
ACLA Members who attended the Vice President’s meeting today at the White House:
- Jon R. Cohen, M.D., Executive Chairman, BioReference Laboratories
- Jerry W. Hussong, M.D., M.B.A., Chief Executive Officer, Sonic Healthcare USA
- Julie Khani, President of the American Clinical Laboratory Association
- William G. Morice II, M.D., Ph.D., President, Mayo Clinic Laboratories
- Sherrie L. Perkins M.D., Ph.D, Chief Executive Officer, ARUP Laboratories
- Stephen H. Rusckowski, Chairman, President and CEO, Quest Diagnostics
- Adam Schechter, President and CEO of LabCorp
COVID-19 Response Efforts
Role of Commercial Laboratories
OVERVIEW
In any outbreak, Centers for Disease Control and Prevention (CDC) laboratories, supported by state public health laboratories, have primary responsibility for diagnosing patients. In recent public health emergencies, including the SARS and Zika outbreaks, commercial laboratories have supported public response and expanded test capacity.
ACLA has a memorandum of understanding with the CDC, the Association of Public Health Laboratories, and the Council of State and Territorial Epidemiologists to strengthen coordination in the event of public health emergencies. Over the past several weeks, the CDC has been actively utilizing ACLA and the MOU to keep ACLA member laboratories with infectious disease expertise informed on the progression of the current outbreak, the government response, and how our member laboratories can best be prepared to support those efforts.
CURRENT RESPONSE EFFORTS
On Saturday, February 29, the FDA issued new guidance for high complexity laboratories, including commercial laboratories, to perform coronavirus testing as soon as validation is complete. Prior to Saturday’s announcement, ACLA members were already working to develop novel tests for COVID-19 and remain in close communication with our public health partners at the CDC.
As of Wednesday, March 4, 2020 ACLA members are not yet collecting, processing or transporting specimens for COVID-19 testing from patients suspected of having, or confirmed to have, COVID-19.
ACLA is committed to supporting our public health partners and rapid response efforts. We’re working closely with our members—and in close coordination with state and local public health labs, hospitals, the CDC and the FDA—to increase overall national capacity. Over the next several weeks, commercial labs are working to bring online additional testing capacity at which point we will have a more informed assessment on the number of tests that can be processed.
KEY FACTORS IMPACTING TESTING CAPACITY
There are a number of critical factors that impact commercial labs’ ability to increase testing capacity in response to COVID-19 while also maintaining ongoing diagnostic operations for millions of Americans across the country. These include:
- Expand Emergency Use Authorizations (EUAs) to allow as many diagnostic manufacturers and labs to come online with tests. We urge the Administration to take immediate steps to approve emergency use authorizations (EUAs) for as many test platforms and instruments as possible in order to provide swift and accelerated access to diagnostic tests.
- Clear guidelines around screening that ensure high-risk patients are quickly identified and tested as soon as possible. While we support expanded access to testing services, we must ensure that those patients who are particularly at high-risk for COVID-19 are prioritized for testing and that we are able to ensure accurate, reliable results as new tests begin to go “live” in the coming weeks. Testing guidelines and recommendations must also account for repeat or secondary testing in cases where public health officials may require a second validating test for quarantine status. This is particularly important as labs are coming “on-line” for the first time with new tests where there is required time to ensure accuracy and reliability in diagnosing this infectious disease.
- Clear recommendations and processes for transport and handling of specimens. Given the ongoing risk of exposure for technicians handling specimens, clinical labs must have a stable supply of protective medical equipment and clothing (including gloves, marks, etc.) for handling infectious disease specimens. There also must be clear processes for providers on how to prepare specimens for shipping and transport as needed.
- Clear validation requirements. Public agencies should clearly and transparently share information about validation requirements, regulatory changes and data-sharing standards with commercial laboratories in a timely manner.
- Increased federal funding to support expanded testing and diagnostic operations. We ask Congress to provide supplemental funding for the PHEF under Section 319(b) of the Public Health Service Act so that these resources can be made readily available to support commercial laboratory surge capacity. With a dedicated funding stream from HHS under the PHEF, commercial laboratories can invest in the materials, time, labor, and other infrastructure necessary to ensure that reliable, rapid testing to diagnose COVID-19 remains accessible when our nation needs it most.
ACLA Designates Annual Meeting “Handshake-Free”
WASHINGTON, D.C. — In light of recent concerns about the spread of COVID-19 in the United States, the American Clinical Laboratory Association (ACLA) is encouraging attendees to go handshake-free at Wednesday’s Annual Meeting.
“As leading voices within the clinical laboratory diagnostics community, attendees recognize the importance of aligning our practices with the industry’s core commitment to public health, the driving force that brings us together each year,” said ACLA President Julie Khani. “While the Centers for Disease Control (CDC) has deemed the immediate health risk from novel coronavirus to be low, designating the meeting handshake-free is an easy, practical step that underscores our commitment to the health and safety of our colleagues and communities.”
ACLA encourages all attendees to practice every day preventative measures in accordance with CDC guidelines, including:
- Cover your cough or sneeze with a tissue.
- Wash your hands often with soap and water for at least 20 seconds.
- Avoid touching your eyes, nose and mouth.
For more information, please visit the CDC website.
About ACLA’s COVID-19 Response Efforts
On Saturday, February 29, the FDA issued new guidance for high complexity laboratories, including commercial laboratories, to perform coronavirus testing as soon as validation is complete. ACLA members are working to develop novel tests for COVID-19, as well as supporting other ways to bolster testing capacity. Over the past several weeks, the CDC has been actively utilizing ACLA and the MOU to keep ACLA member laboratories with infectious disease expertise informed on the progression of the current outbreak, the government response, and how our member laboratories can best be prepared to support those efforts. This MOU was established as public and commercial health partners reflected on the Zika outbreak and how to strengthen communication and coordination in future health emergencies. This past summer, ACLA and several of our members also participated in a tabletop exercise at the CDC that simulated a real-life infectious disease outbreak, requiring participating organizations to put their rapid response plans to the test and identify gaps and potential solutions to guide future preparedness efforts.
About ACLA’s Annual Meeting
ACLA’s Annual Meeting convenes key policymakers and leaders from the clinical laboratory diagnostics community for presentations and discussions about the dynamic landscapes that will have significant impact on the next generation of diagnostics and laboratory tests for patients. This year’s speakers include FDA Commissioner Stephen Hahn and Rep. Scott Peters (D-CA).
About The American Clinical Laboratory Association (ACLA)
ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.
FDA expands coronavirus testing capacity with support of commercial labs
WASHINGTON, D.C. – ACLA is currently reviewing the FDA’s guidance for high complexity, CLIA-certified laboratories (which includes hospital, academic, and commercial laboratories) to provide coronavirus testing in advance of Emergency Use Authorization (EUA). The guidance permits high complexity laboratories to start offering coronavirus testing as soon as validation is complete. The FDA recommends that a laboratory submit the EUA request to the agency fifteen business days after validation.
“As part of our industry’s strong commitment to advancing public health in the U.S., commercial laboratories are ready to support increased testing capacity for the novel coronavirus response,” said Julie Khani, president of ACLA. “We are encouraged by the FDA’s decision to make additional high-quality testing available, and welcome the opportunity to further support our public health partners.”
ACLA has a memorandum of understanding with the CDC, the Association of Public Health Laboratories, and the Council of State and Territorial Epidemiologists to strengthen coordination in the event of public health emergencies. Over the past several weeks, the CDC has been actively utilizing ACLA and the MOU to keep ACLA member laboratories with infectious disease expertise informed on the progression of the current outbreak, the government response, and how our member laboratories can best be prepared to support those efforts.
As has been publicly reported, some ACLA members are working to develop novel tests for COVID-19, as well as supporting other ways to bolster testing capacity.
In any outbreak, Centers for Disease Control and Prevention (CDC) laboratories, supported by state and local public health laboratories, have primary responsibility for diagnosing patients. Commercial laboratories stand ready to work closely with health officials to meet that demand, testing specimens sent in by clinicians. In recent public health emergencies, including the SARS and Zika outbreaks, commercial laboratories have supported public response and expanded test capacity.
Please visit the CDC’s website for the latest developments, resources and recommendations.
#
ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.
Update on COVID-19 Outbreak
Commercial Labs Working Closely with Public Health Partners, Stand Ready To Support Increased Test Capacity If Needed
WASHINGTON, D.C. — In response to the latest developments and spread of the COVID-19 in the United States, ACLA President Julie Khani released the following statement:
“As part of our commitment to supporting the emergency preparedness and public health of the United States, commercial laboratories are ready to support increased testing capacity for the novel coronavirus response, if needed.
In addition, as has been publicly reported, some ACLA members are working to develop novel tests for COVID-19, as well as supporting other ways to bolster testing capacity.
In any outbreak, Centers for Disease Control and Prevention (CDC) laboratories, supported by state public health laboratories, have primary responsibility for diagnosing patients. Currently, the CDC and other public health labs are the only entities authorized to provide testing for COVID-19 in the United States. At this time, commercial laboratories are not collecting, processing or transporting specimens for COVID-19 testing from patients suspected of having, or confirmed to have, COVID-19.
In the event that demand for testing exceeds the capacity of state and local public health labs, commercial laboratories stand ready to work closely with health officials to meet that demand, testing specimens sent in by clinicians, if needed. In recent public health emergencies, including the SARS and Zika outbreaks, commercial laboratories have supported public response and expanded test capacity.
ACLA has a memorandum of understanding with the CDC, the Association of Public Health Laboratories, and the Council of State and Territorial Epidemiologists to strengthen coordination in the event of public health emergencies. Over the past several weeks, the CDC has been actively utilizing ACLA and the MOU to keep ACLA member laboratories with infectious disease expertise informed on the progression of the current outbreak, the government response, and how our member laboratories can best be prepared to support those efforts.”
To learn more about ACLA’s ongoing collaborative efforts to strengthen communication and coordination between public and private sector partners, including our participation in the CDC’s tabletop exercise last year, click here.
#
ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.
