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Statement on Recent FDA Actions To Expand COVID-19 Testing

Public Health Preparedness and Infrastructure, ACLA News, All News, Featured News, ACLA Press Releases

WASHINGTON, D.C. – Following the FDA’s actions announced on March 16, ACLA President Julie Khani released the following statement:

“The FDA’s guidance released on Saturday, February 29th cleared the regulatory hurdles to allow commercial labs to immediately begin testing patients as soon as test validation was complete, and our members began accepting specimens for testing less than a week later.

The FDA has recently taken several positive steps to make additional platforms and instruments available to provide accelerated access to diagnostic tests for patients. For example, the March 13 updated guidance expanding eligible swabs was an important step forward, as it allowed commercial laboratories to work with additional suppliers to access necessary specimen collection tools. In addition, the recent FDA approval of large automated platforms for testing is expected to dramatically increase testing capacity. 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.

ACLA is reviewing the FDA’s actions announced last night. While New York State Dept of Health has a long-established and experienced oversight program for Lab Developed Tests (LDTs), this is not the case for every state. To maintain specimen integrity and deliver the clear and reliable results that patients and clinicians depend on, it is essential that all laboratories conducting testing for COVID-19, regardless of location or state, have the appropriate expertise, equipment and training to do so.”

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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.

Commercial Labs Step Up Capacity, Collaborate With Public Health Partners To Respond To National Emergency

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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.”

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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

Public Health Preparedness and Infrastructure, All News, Featured News

Last Updated March 2023

Recent Updates

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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.

DateApproximate Tests PerformedApproximate Total Tests to Date
May 27, 2021170,000125,397,000
May 26, 2021183,000125,227,000
May 25, 2021188,000125,044,000
May 24, 202185,000124,856,000
May 23, 202185,000124,772,000
May 22, 2021159,000124,686,000
May 21, 2021179,000124,532,000
May 20, 2021197,000124,354,000
May 19, 2021218,000124,168,000
May 18, 2021215,000123,945,000
May 17, 202193,000123,736,000
May 16, 202199,000123,652,000
May 15, 2021185,000123,552,000
May 14, 2021195,000123,366,000
May 13, 2021218,000123,171,000
May 12, 2021240,000123,179,000
May 11, 2021231,000122,939,000
May 10, 2021100,000122,709,000
May 9, 2021111,000122,610,000
May 8, 2021188,000122,496,000
May 7, 2021216,000122,309,000
May 6, 2021236,000122,095,000
May 5, 2021264,000121,859,000
May 4, 2021249,000121,595,000
May 3, 2021106,000121,345,000
May 2, 2021114,000121,243,000
May 1, 2021216,000121,129,000
April 30, 2021228,000120,913,000
April 29, 2021260,000120,685,000
April 28, 2021276,000120,416,000
April 27, 2021260,000120,140,000
April 26, 2021113,000119,880,000
April 25, 2021131,000119,771,000
April 24, 2021233,000119,639,000
April 23, 2021249,000119,408,000
April 22, 2021258,000119,158,000
April 21, 2021298,000118,900,000
April 20, 2021274,000118,601,000
April 19, 2021121,000118,326,000
April 18, 2021144,000118,205,000
April 17, 2021241,000118,061,000
April 16, 2021257,000117,819,000
April 15, 2021282,000117,546,000
April 14, 2021310,000117,264,000
April 13, 2021260,000116,954,000
April 12, 2021125,000116,694,000
April 11, 2021150,000116,565,000
April 10, 2021243,000116,415,000
April 9, 2021260,000116,172,000
April 8, 2021292,000115,921,000
April 7, 2021311,000115,629,000
April 6, 2021265,000115,318,000
April 5, 2021119,000115,052,000
April 4, 2021150,000114,938,000
April 3, 2021237,000114,787,000
April 2, 2021263,000114,551,000
April 1, 2021286,000114,288,000
March 31, 2021303,000114,005,000
March 30, 2021274,000113,702,000
March 29, 2021134,000113,429,000
March 28, 2021152,000113,297,000
March 27, 2021251,000113,146,000
March 26, 2021271,000112,895,000
March 25, 2021285,000112,622,000
March 24, 2021305,000112,321,000
March 23, 2021273,000112,016,000
March 22, 2021130,000111,743,000
March 21, 2021145,000111,613,000
March 20, 2021240,000111,467,000
March 19, 2021262,000111,226,000
March 18, 2021292,000110,964,000
March 17, 2021311,000110,675,000
March 16, 2021267,000110,365,000
March 15, 2021130,000110,098,000
March 14, 2021165,000109,970,000
March 13, 2021237,000109,805,000
March 12, 2021267,000109,570,000
March 11, 2021285,000109,302,000
March 10, 2021332,000109,032,000
March 9, 2021294,000108,701,000
March 8, 2021131,000108,411,000
March 7, 2021147,000108,280,000
March 6, 2021260,000108,133,000
March 5, 2021283,000107,874,000
March 4, 2021312,000107,591,000
March 3, 2021291,000107,279,000
March 2, 2021296,000106,989,000
March 1, 2021143,000106,692,000
February 28, 2021160,000106,529,000
February 27, 2021278,000106,367,000
February 26, 2021302,000106,089,000
February 25, 2021337,000105,787,000
February 24, 2021385,000105,446,000
February 23, 2021321,000105,061,000
February 22, 2021162,000104,739,000
February 21, 2021182,000104,591,000
February 20, 2021267,000104,405,000
February 19, 2021266,000104,138,000
February 18, 2021283,000103,872,000
February 17, 2021293,000103,607,000
February 16, 2021224,000103,313,000
February 15, 2021157,000103,089,000
February 14, 2021175,000102,932,000
February 13, 2021298,000102,756,000
February 12, 2021334,000102,458,000
February 11, 2021382,000102,124,000
February 10, 2021394,000101,751,000
February 9, 2021355,000101,358,000
February 8, 2021167,000101,003,000
February 7, 2021231,000100,851,000
February 6, 2021363,000100,618,000
February 5, 2021399,000100,255,000
February 4, 2021423,00099,864,000
February 3, 2021420,00099,440,000
February 2, 2021325,00099,020,000
February 1, 2021171,00098,695,000
January 31, 2021268,00098,527,000
January 30, 2021393,00098,257,000
January 29, 2021431,00097,864,000
January 28, 2021475,00097,433,000
January 27, 2021521,00096,957,000
January 26, 2021382,00096,437,000
January 25, 2021235,00096,055,000
January 24, 2021342,00095,829,000
January 23, 2021445,00095,486,000
January 22, 2021476,00095,041,000
January 21, 2021509,00094,573,000
January 20, 2021515,00094,064,000
January 19, 2021410,00093,550,000
January 18, 2021233,00093,140,000
January 17, 2021361,00092,915,000
January 16, 2021488,00092,554,000
January 15, 2021539,00092,066,000
January 14, 2021580,00091,527,000
January 13, 2021587,00090,947,000
January 12, 2021467,00090,360,000
January 11, 2021317,00089,893,000
January 10, 2021431,00089,553,000
January 9, 2021526,00089,122,000
January 8, 2021583,00088,595,000
January 7, 2021601,00088,067,000
January 6, 2021594,00087,465,000
January 5, 2021445,00086,872,000
January 4, 2021300,00086,427,000
January 3, 2021294,00086,129,000
January 2, 2021333,00085,833,000
January 1, 2021471,00085,500,000
December 31, 2020557,00085,029,000
December 30, 2020582,00084,472,000
December 29, 2020424,00083,891,000
December 28, 2020243,00083,467,000
December 27, 2020293,00083,236,000
December 26, 2020300,00082,950,000
December 25, 2020479,00082,650,000
December 24, 2020580,00082,190,000
December 23, 2020588,00081,610,000
December 22, 2020460,00081,021,000
December 21, 2020360,00080,561,000
December 20, 2020442,00080,215,000
December 19, 2020538,00079,783,000
December 18, 2020555,00079,245,000
December 17, 2020551,00078,690,000
December 16, 2020560,00078,140,000
December 15, 2020461,00077,580,000
December 14, 2020338,00077,120,000
December 13, 2020476,00076,786,000
December 12, 2020556,00076,310,000
December 11, 2020568,00075,754,000
December 10, 2020592,00075,186,000
December 9, 2020559,00074,594,000
December 8, 2020454,00074,035,000
December 7, 2020385,00073,581,000
December 6, 2020458,00073,196,000
December 5, 2020547,00072,737,000
December 4, 2020555,00072,191,000
December 3, 2020570,00071,646,000
December 2, 2020556,00071,076,000
December 1, 2020416,00070,519,000
November 30, 2020313,00070,103,000
November 29, 2020400,00069,790,000
November 28, 2020461,00069,390,000
November 27, 2020485,00068,951,000
November 26, 2020550,00068,466,000
November 25, 2020603,00067,916,000
November 24, 2020515,00067,313,000
November 23, 2020460,00066,780,000
November 22, 2020514,00066,337,000
November 21, 2020561,00065,823,000
November 20, 2020547,00065,262,000
November 19, 2020577,00064,707,000
November 18, 2020545,00064,129,000
November 17, 2020500,00063,585,000
November 16, 2020378,00063,084,000
November 15, 2020445,00062,706,000
November 14, 2020490,00062,261,000
November 13, 2020486,00061,772,000
November 12, 2020500,00061,267,000
November 11, 2020495,00060,767,000
November 10, 2020377,00060,271,000
November 9, 2020320,00059,895,000
November 8, 2020386,00059,575,000
November 7, 2020474,00059,189,000
November 6, 2020444,00058,714,000
November 5, 2020456,00058,261,000
November 4, 2020442,00057,805,000
November 3, 2020350,00057,363,000
November 2, 2020289,00057,013,000
November 1, 2020361,00056,724,000
October 31, 2020399,00056,364,000
October 30, 2020359,00055,965,000
October 29, 2020424,00055,599,000
October 28, 2020419,00055,175,000
October 27, 2020326,00054,755,000
October 26, 2020258,00054,429,000
October 25, 2020323,00054,170,000
October 24, 2020407,00053,834,000
October 23, 2020419,00053,427,000
October 22, 2020400,00053,008,000
October 21, 2020397,00052,608,000
October 20, 2020296,00052,211,000
October 19, 2020202,00051,915,000
October 18, 2020316,00051,712,000
October 17, 2020385,00051,395,000
October 16, 2020367,00051,010,000
October 15, 2020407,00050,651,000
October 14, 2020375,00050,244,000
October 13, 2020309,00049,869,000
October 12, 2020248,00049,560,000
October 11, 2020330,00049,312,000
October 10, 2020381,00048,983,000
October 9, 2020397,00048,603,000
October 8, 2020406,00048,203,000
October 7, 2020399,00047,797,000
October 6, 2020284,00047,398,000
October 5, 2020195,00047,114,000
October 4, 2020259,00046,913,000
October 3, 2020330,00046,651,000
October 2, 2020344,00046,322,000
October 1, 2020381,00045,979,000
September 30, 2020363,00045,598,000
September 29, 2020268,00045,235,000
September 28, 2020178,00044,967,000
September 27, 2020244,00044,789,000
September 26, 2020337,00044,540,000
September 25, 2020361,00044,203,000
September 24, 2020357,00043,842,000
September 23, 2020348,00043,485,000
September 22, 2020253,00043,137,000
September 21, 2020156,00042,884,000
September 20, 2020253,00042,723,000
September 19, 2020326,00042,475,000
September 18, 2020350,00042,149,000
September 17, 2020338,00041,772,000
September 16, 2020326,00041,434,000
September 15, 2020236,000
41,108,000
September 14, 2020167,00040,872,000
September 13, 2020256,00040,705,000
September 12, 2020311,00040,450,000
September 11, 2020300,00040,139,000
September 10, 2020331,00039,847,000
September 9, 2020242,00039,516,000
September 8, 2020141,00039,274,000
September 7, 2020144,00039,133,000
September 6, 2020235,00038,986,000
September 5, 2020283,00038,751,000
September 4, 2020317,00038,468,000
September 3, 2020331,00038,151,000
September 2, 2020305,00037,820,000
September 1, 2020232,00037,515,000
August 31, 2020177,00037,283,000
August 30, 2020256,00037,106,000
August 29, 2020318,00036,850,000
August 28, 2020334,00036,531,000
August 27, 2020330,00036,191,000
August 26, 2020324,00035,862,000
August 25, 2020246,000
35,538,000
August 24, 2020180,00035,291,000
August 23, 2020244,00035,111,000
August 22, 2020329,00034,867,000
August 21, 2020333,00034,538,000
August 20, 2020369,00034,204,000
August 19, 2020348,00033,835,000
August 18, 2020255,00033,487,000
August 17, 2020206,00033,232,000
August 16, 2020271,00033,026,000
August 15, 2020328,00032,741,000
August 14, 2020364,00032,413,000
August 13, 2020369,00032,049,000
August 12, 2020363,00031,680,000
August 11, 2020301,00031,317,000
August 10, 2020264,00031,016,000
August 9, 2020319,00030,752,000
August 8, 2020373,00030,433,000
August 7, 2020397,00030,059,000
August 6, 2020378,00029,662,000
August 5, 2020388,00029,295,000
August 4, 2020308,00028,907,000
August 3, 2020279,00028,600,000
August 2, 2020345,00028,321,000
August 1, 2020383,00027,971,000
July 31, 2020378,00027,588,000
July 30, 2020408,00027,210,000
July 29, 2020391,00026,802,000
July 28, 2020349,00026,411,000
July 27, 2020320,00026,062,000
July 26, 2020380,00025,742,000
July 25, 2020425,00025,362,000
July 24, 2020419,00024,925,000
July 23, 2020419,00024,506,000
July 22, 2020410,00024,088,000
July 21, 2020368,00023,678,000
July 20, 2020341,00023,309,000
July 19, 2020356,00022,968,000
July 18, 2020378,00022,610,000
July 17, 2020366,00022,233,000
July 16, 2020369,00021,868,000
July 15, 2020390,00021,499,000
July 14, 2020349,00021,109,000
July 13, 2020325,00020,760,000
July 12, 2020323,00020,434,000
July 11, 2020358,00020,111,000
July 10, 2020350,00019,753,000
July 9, 2020355,00019,410,000
July 8, 2020349,00019,055,000
July 7, 2020300,00018,706,000
July 6, 2020274,00018,406,000
July 5, 2020290,00018,133,000
July 4, 2020351,00017,843,000
July 3, 2020362,00017,492,000
July 2, 2020348,00017,131,000
July 1, 2020335,00016,782,000
June 30, 2020307,00016,447,000
June 29, 2020263,00016,140,000
June 28, 2020287,00015,877,000
June 27, 2020319,00015,589,000
June 26, 2020332,00015,270,000
June 25, 2020317,00014,942,000
June 24, 2020308,00014,625,000
June 23, 2020263,00014,317,000
June 22, 2020219,00014,054,000
June 21, 2020234,00013,835,000
June 20, 2020300,00013,601,000
June 19, 2020291,00013,291,000
June 18, 2020295,00013,000,000
June 17, 2020282,00012,706,000
June 16, 2020240,00012,424,000
June 15, 2020207,00012,185,000
June 14, 2020229,00011,978,000
June 13, 2020265,00011,744,000
June 12, 2020262,00011,479,000
June 11, 2020254,00011,217,000
June 10, 2020255,00010,962,000
June 9, 2020204,00010,707,000
June 8, 2020167,00010,503,000
June 7, 2020215,00010,336,000
June 6, 2020229,00010,121,000
June 5, 2020256,0009,892,000
June 4, 2020264,0009,627,000
June 3, 2020245,0009,364,000
June 2, 2020214,0009,199,000
June 1, 2020190,0008,905,000
May 31, 2020215,0008,715,000
May 30, 2020226,0008,500,000
May 29, 2020238,0008,274,000
May 28, 2020218,0008,030,000
May 27, 2020209,0007,812,000
May 26, 2020163,0007,604,000
May 25, 2020179,0007,441,000
May 24, 2020192,0007,262,000
May 23, 2020198,0007,070,000
May 22, 2020200,0006,872,000
May 21, 2020203,0006,672,000
May 20, 2020190,0006,467,000
May 19, 2020165,0006,277,000
May 18, 2020134,0006,112,000
May 17, 2020159,0005,978,000
May 16, 2020179,0005,819,000
May 15, 2020177,0005,640,000
May 14, 2020180,0005,455,000
May 13, 2020163,0005,275,000
May 12, 2020139,0005,112,000
May 11, 202096,0004,972,000
May 10, 2020125,0004,876,000
May 9, 2020142,0004,752,000
May 8, 2020148,000 4,610,000
May 7, 2020145,0004,462,000
May 6, 2020147,0004,316,000
May 5, 2020121,0004,170,000
May 4, 202086,0004,048,000
May 3, 2020105,0003,963,000
May 2, 2020123,0003,858,000
May 1, 2020130,0003,735,000
April 30, 2020125,0003,605,000
April 29, 2020118,0003,480,000
April 28, 202098,0003,362,000
April 27, 202066,4553,264,000
April 26, 202090,0003,197,000
April 25, 2020112,0003,107,000
April 24, 2020115,0002,995,000
April 23, 2020109,0002,880,000
April 22, 2020105,000 2,771,000
April 21, 202083,0002,666,000
April 20, 202056,0002,583,000
April 19, 202068,0002,527,000
April 18, 202088,0002,459,000
April 17, 202091,0002,371,000
April 16, 202085,0002,280,000
April 15, 202076,0002,195,000
April 14, 202063,0002,119,000
April 13, 202043,0002,056,000
April 12, 202075,0002,013,000
April 11, 202091,0001,937,000
April 10, 202097,0001,846,000
April 9, 202095,0001,749,000
April 8, 202099,0001,654,000
April 7, 202075,0001,555,000
April 6, 202072,0001,480,000
April 5, 2020108,0001,408,000
April 4, 2020106,0001,300,000
April 3, 2020101,0001,194,000
April 2, 2020102,0001,093,000
April 1, 202092,000992,000
March 31, 202092,000900,000
March 30, 202075,000807,000
March 29, 202082,000732,000
March 28, 202084,000650,000
March 27, 202080,000565,000
March 26, 202080,000485,000
March 25, 202067,000405,000
March 24, 202057,000338,000
March 23, 202047,000281,000
March 22, 202051,000234,000
March 21, 202054,000183,000
March 20, 202041,000129,000
March 19, 202025,00088,000
March 18, 202020,10063,000
March 17, 202014,30043,000
March 16, 20208,20027,000

*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.

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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

Public Health Preparedness and Infrastructure, ACLA News, All News, Featured News, ACLA Press Releases

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

ACLA News, All News, Featured News, ACLA Press Releases

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.”

 

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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

ACLA News, All News, Featured News, ACLA Press Releases

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.