FDA Control of Laboratory Developed Tests (LDTs) Building Momentum with VALID Act

𝗙𝗗𝗔 𝗢𝗩𝗘𝗥𝗦𝗜𝗚𝗛𝗧 𝗡𝗘𝗘𝗗𝗘𝗗 𝗦𝗢 𝗟𝗔𝗕 𝗧𝗘𝗦𝗧𝗦 𝗗𝗢 𝗠𝗢𝗥𝗘 𝗚𝗢𝗢𝗗 𝗧𝗛𝗔𝗡 𝗛𝗔𝗥𝗠 

𝐓𝐡𝐞 Center for Genomic Interpretation (CGI) 𝐬𝐮𝐩𝐩𝐨𝐫𝐭𝐬 𝐭𝐡𝐞 𝗩𝗔𝗟𝗜𝗗 (𝗩𝗲𝗿𝗶𝗳𝘆𝗶𝗻𝗴 𝗔𝗰𝗰𝘂𝗿𝗮𝘁𝗲, 𝗟𝗲𝗮𝗱𝗶𝗻𝗴-𝗲𝗱𝗴𝗲 𝗜𝗩𝗖𝗧 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁) 𝗔𝗰𝘁. This bill was introduced in Congress in December 2018, but is picking up momentum again amidst recent lawsuits targeting clinical labs due to inaccuracies seen in Laboratory Developed Tests (LDTs). This doctor-ordered clinical testing market is referred to in the article referenced below as the “Wild West”. LDTs are regulatory blind spots with no #FDA oversight. Over 99% of the tests currently marketed in the Clinical Genetic and Genomic testing arena that drive patient care are LDTs. 𝗪𝗵𝘆 𝗮𝗿𝗲 𝗟𝗗𝗧𝘀 𝗮 𝗽𝗿𝗼𝗯𝗹𝗲𝗺?

𝗣𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝗮𝗿𝗲 𝗡𝗢𝗧 𝗻𝗲𝗰𝗲𝘀𝘀𝗮𝗿𝗶𝗹𝘆 𝗴𝗲𝘁𝘁𝗶𝗻𝗴 𝗮𝗰𝗰𝘂𝗿𝗮𝘁𝗲 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 𝘁𝗵𝗮𝘁 𝗮𝘀𝘀𝗶𝘀𝘁 𝘁𝗵𝗲𝗺 𝗶𝗻 𝗺𝗮𝗸𝗶𝗻𝗴 𝗱𝗲𝗰𝗶𝘀𝗶𝗼𝗻𝘀 𝘄𝗶𝘁𝗵 𝗹𝗶𝗳𝗲 𝗮𝗹𝘁𝗲𝗿𝗶𝗻𝗴 𝗶𝗺𝗽𝗮𝗰𝘁. If these tests are wrong, patients’ lives change, and oftentimes not for the better…Some examples include:  

Cancer therapies that could potentially extend life are not an option
Expecting mothers terminate healthy pregnancies due to a false positive test result
A woman chooses to remove her breasts or ovaries when those surgeries weren’t necessary

What if this was your family member, friend or a patient you are treating or covering as a Health Insurance payer?  Wouldn’t you want the test that is ordered to help you and your healthcare team make the right decision for your medical management to be accurate?  

A recent article published on March 16, 2022 by Adam Bonislawski, 360Dx shared both sides of this argument in the article:  FDA Control of LDTs Looms as Momentum Builds for the VALID Act.  https://www.360dx.com/policy-legislation/fda-control-ldts-looms-momentum-builds-valid-act#.YjJArWDMJD8 

This 𝗯𝗶-𝗽𝗮𝗿𝘁𝗶𝘀𝗮𝗻 𝗯𝗶𝗹𝗹 would change the regulation of the LDT space giving the FDA unquestionable oversight.  What follows are a few extra thoughts from CGI on the hoped for passing of this much needed regulation to improve patient care, as well as CGI responses to some of the embedded quotes (𝘪𝘵𝘢𝘭𝘪𝘤𝘴) in the 360Dx article.

All of the high volume genetic and genomic LDT labs have CLIA certification and #CAP accreditation. These are helpful to some degree, but do NOT provide true evaluation or checking to see if all of the different types of tests being offered by these labs are actually accurate and clinically valid.

“𝘐𝘯 𝘢𝘯 𝘦𝘮𝘢𝘪𝘭, 𝘚𝘵𝘦𝘱𝘩𝘦𝘯 𝘔𝘢𝘴𝘵𝘦𝘳, 𝘈𝘈𝘊𝘊 𝘱𝘳𝘦𝘴𝘪𝘥𝘦𝘯𝘵 [𝘈𝘮𝘦𝘳𝘪𝘤𝘢𝘯 𝘈𝘴𝘴𝘰𝘤𝘪𝘢𝘵𝘪𝘰𝘯 𝘧𝘰𝘳 𝘊𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘊𝘩𝘦𝘮𝘪𝘴𝘵𝘳𝘺], 𝘢𝘯𝘥 𝘤𝘩𝘪𝘦𝘧 𝘰𝘧 𝘵𝘩𝘦 𝘥𝘪𝘷𝘪𝘴𝘪𝘰𝘯 𝘰𝘧 𝘭𝘢𝘣𝘰𝘳𝘢𝘵𝘰𝘳𝘺 𝘮𝘦𝘥𝘪𝘤𝘪𝘯𝘦 𝘢𝘵 𝘊𝘩𝘪𝘭𝘥𝘳𝘦𝘯’𝘴 𝘏𝘰𝘴𝘱𝘪𝘵𝘢𝘭 𝘰𝘧 𝘗𝘩𝘪𝘭𝘢𝘥𝘦𝘭𝘱𝘩𝘪𝘢, 𝘯𝘰𝘵𝘦𝘥 𝘵𝘩𝘢𝘵 𝘸𝘩𝘪𝘭𝘦 “𝘊𝘓𝘐𝘈 𝘪𝘵𝘴𝘦𝘭𝘧 𝘥𝘰𝘦𝘴 𝘯𝘰𝘵 𝘳𝘦𝘲𝘶𝘪𝘳𝘦 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘭𝘢𝘣𝘰𝘳𝘢𝘵𝘰𝘳𝘪𝘦𝘴 𝘵𝘰 𝘦𝘴𝘵𝘢𝘣𝘭𝘪𝘴𝘩 𝘵𝘩𝘦 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘷𝘢𝘭𝘪𝘥𝘪𝘵𝘺 𝘰𝘧 𝘓𝘋𝘛𝘴, 𝘵𝘩𝘦 𝘊𝘰𝘭𝘭𝘦𝘨𝘦 𝘰𝘧 𝘈𝘮𝘦𝘳𝘪𝘤𝘢𝘯 𝘗𝘢𝘵𝘩𝘰𝘭𝘰𝘨𝘪𝘴𝘵𝘴 [𝘊𝘈𝘗] 𝘢𝘯𝘥 𝘵𝘩𝘦 𝘑𝘰𝘪𝘯𝘵 𝘊𝘰𝘮𝘮𝘪𝘴𝘴𝘪𝘰𝘯 — 𝘣𝘰𝘵𝘩 𝘰𝘧 𝘸𝘩𝘪𝘤𝘩 𝘢𝘳𝘦 𝘥𝘦𝘦𝘮𝘦𝘥 𝘢𝘤𝘤𝘳𝘦𝘥𝘪𝘵𝘪𝘯𝘨 𝘰𝘳𝘨𝘢𝘯𝘪𝘻𝘢𝘵𝘪𝘰𝘯𝘴 𝘶𝘯𝘥𝘦𝘳 𝘊𝘓𝘐𝘈 — 𝘥𝘰 𝘳𝘦𝘲𝘶𝘪𝘳𝘦 𝘵𝘩𝘢𝘵 𝘭𝘢𝘣𝘴 𝘥𝘰𝘤𝘶𝘮𝘦𝘯𝘵 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘷𝘢𝘭𝘪𝘥𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘓𝘋𝘛𝘴.” https://www.360dx.com/policy-legislation/fda-control-ldts-looms-momentum-builds-valid-act#.YjJArWDMJD8 

CGI’s response: It is true that CLIA does not require clinical validity. The remainder of 𝗗𝗿. 𝗠𝗮𝘀𝘁𝗲𝗿’𝘀 𝗰𝗼𝗺𝗺𝗲𝗻𝘁 𝗵𝗼𝘄𝗲𝘃𝗲𝗿 𝗶𝘀 𝗶𝗻𝘁𝗲𝗻𝘁𝗶𝗼𝗻𝗮𝗹𝗹𝘆 𝗼𝗯𝗳𝘂𝘀𝗰𝗮𝘁𝗶𝗻𝗴. CAP promotes itself as the superior and complete solution to the clinical validity problem of laboratory testing. However, for genetic/genomic testing, only one CAP checklist requirement addresses clinical validity. CAP’s evidence of compliance requires only the following: “Records of validation studies to establish clinical performance and/or appropriate cited literature.”

The laboratory can effectively make up their own parameters for how to validate their test, both clinically and analytically. Therefore, 𝗺𝗮𝗻𝘆 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀 𝗱𝗲𝗽𝗹𝗼𝘆 𝗶𝗻𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗼𝗿 𝗶𝗻𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝘃𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀 𝗳𝗼𝗿 𝘁𝗵𝗲𝗶𝗿 𝘁𝗲𝘀𝘁𝘀, 𝘀𝗼𝗺𝗲𝘁𝗶𝗺𝗲𝘀 𝗶𝗻𝘁𝗲𝗻𝘁𝗶𝗼𝗻𝗮𝗹𝗹𝘆 𝗱𝗲𝘀𝗶𝗴𝗻𝗲𝗱 𝘁𝗼 𝗵𝗶𝗱𝗲 𝗳𝗹𝗮𝘄𝘀. Or they simply cite literature without any direct clinical studies of their own test, remaining unaware that their own test is clinically inaccurate or ineffective. 𝗧𝗵𝗲𝘀𝗲 𝗹𝗮𝗯𝘀 𝗮𝗿𝗲 𝘀𝘁𝗶𝗹𝗹 𝗶𝗻 𝗖𝗔𝗣 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲. This means that seemingly equivalent tests from different CAP labs can vary substantially in their actual clinical performance.

Should you believe Dr. Stephen Master’s statement that CAP laboratory accreditation is sufficient to ensure clinical validity of tests coming out of that laboratory? 

NO!

Don’t believe us? 𝗛𝗲𝗿𝗲 𝗮𝗿𝗲 𝗮𝗻𝗼𝗻𝘆𝗺𝗼𝘂𝘀 𝘀𝘁𝗮𝘁𝗲𝗺𝗲𝗻𝘁𝘀 𝗳𝗿𝗼𝗺 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝘆 𝗱𝗶𝗿𝗲𝗰𝘁𝗼𝗿𝘀, 𝗴𝗶𝘃𝗲𝗻 𝘁𝗼 𝘁𝗵𝗲 𝗖𝗗𝗖, 𝗿𝗲𝘃𝗲𝗮𝗹𝗶𝗻𝗴 𝘁𝗵𝗮𝘁 𝗺𝗼𝘀𝘁 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗴𝗲𝗻𝗲𝘁𝗶𝗰/𝗴𝗲𝗻𝗼𝗺𝗶𝗰 𝗹𝗮𝗯𝘀 𝗽𝗹𝗮𝘆 𝘁𝗵𝗲 𝘀𝘆𝘀𝘁𝗲𝗺 𝗶𝗻 𝗼𝗿𝗱𝗲𝗿 𝘁𝗼 𝗵𝗶𝗱𝗲 𝘁𝗵𝗲𝗶𝗿 𝘁𝗲𝘀𝘁𝘀’ 𝗳𝗹𝗮𝘄𝘀 𝘄𝗵𝗶𝗹𝗲 𝘀𝘁𝗶𝗹𝗹 𝗽𝗮𝘀𝘀𝗶𝗻𝗴 𝗖𝗟𝗜𝗔/𝗖𝗔𝗣 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗱 𝗽𝗿𝗼𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 (𝗣𝗧):

“Every laboratory and laboratory director is scared of failing a PT, which means that laboratories want to pick the easy cases for PT.” And “there is no economic incentive for trying to look at more challenging cases. In fact, there is an economic disincentive as well as the fear of failing a PT.” https://www.cdc.gov/cliac/docs/addenda/cliac0419/10a_NGS_Workgroup_Report.pdf

𝗔𝗻𝗱 𝗵𝗲𝗿𝗲’𝘀 𝗮𝗻 𝗲𝘅𝗮𝗺𝗽𝗹𝗲 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗹𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗼𝗳 𝗳𝗼𝘂𝗿 𝘁𝗲𝘀𝘁𝘀 𝗼𝗳𝗳𝗲𝗿𝗲𝗱 𝗯𝘆 𝗖𝗔𝗣 𝗮𝗰𝗰𝗿𝗲𝗱𝗶𝘁𝗲𝗱 𝗶𝗻𝘀𝘁𝗶𝘁𝘂𝘁𝗶𝗼𝗻𝘀 𝘄𝗶𝘁𝗵 𝗵𝗶𝗴𝗵𝗹𝘆 𝘃𝗮𝗿𝗶𝗮𝗯𝗹𝗲 𝘁𝗲𝘀𝘁 𝗽𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲𝘀 𝗳𝗼𝗿 𝘀𝗲𝗲𝗺𝗶𝗻𝗴𝗹𝘆 𝗶𝗱𝗲𝗻𝘁𝗶𝗰𝗮𝗹 𝘁𝗲𝘀𝘁𝘀: “Our orthogonal approach identified false-negative (FN) and false-positive (FP) variants with high confidence and revealed substantial variability among the ctDNA assays, with a range of sensitivity (38% to 89%) and positive predictive value (36% to 80%).” https://ascopubs.org/doi/full/10.1200/PO.18.00191

Continuing with Dr. Stephen Master’s quotes from the 360Dx article: “𝘔𝘢𝘴𝘵𝘦𝘳, 𝘴𝘱𝘦𝘢𝘬𝘪𝘯𝘨 𝘰𝘯 𝘣𝘦𝘩𝘢𝘭𝘧 𝘰𝘧 𝘈𝘈𝘊𝘊, 𝘳𝘢𝘪𝘴𝘦𝘥 𝘴𝘦𝘷𝘦𝘳𝘢𝘭 𝘱𝘳𝘪𝘮𝘢𝘳𝘺 𝘪𝘴𝘴𝘶𝘦𝘴 𝘵𝘩𝘦 𝘰𝘳𝘨𝘢𝘯𝘪𝘻𝘢𝘵𝘪𝘰𝘯 𝘩𝘢𝘴 𝘳𝘦𝘨𝘢𝘳𝘥𝘪𝘯𝘨 𝘵𝘩𝘦 𝘝𝘈𝘓𝘐𝘋 𝘈𝘤𝘵, 𝘪𝘯𝘤𝘭𝘶𝘥𝘪𝘯𝘨 𝘵𝘩𝘦 𝘧𝘢𝘤𝘵 𝘵𝘩𝘢𝘵 𝘵𝘩𝘦 𝘭𝘢𝘸’𝘴 𝘱𝘳𝘰𝘱𝘰𝘴𝘢𝘭 𝘵𝘰 𝘨𝘳𝘢𝘯𝘥𝘧𝘢𝘵𝘩𝘦𝘳 𝘪𝘯 𝘦𝘹𝘪𝘴𝘵𝘪𝘯𝘨 𝘓𝘋𝘛𝘴 𝘤𝘰𝘶𝘭𝘥 𝘱𝘳𝘦𝘷𝘦𝘯𝘵 𝘭𝘢𝘣𝘴 𝘧𝘳𝘰𝘮 𝘮𝘢𝘬𝘪𝘯𝘨 𝘯𝘦𝘦𝘥𝘦𝘥 𝘶𝘱𝘥𝘢𝘵𝘦𝘴 𝘵𝘰 𝘵𝘩𝘰𝘴𝘦 𝘓𝘋𝘛𝘴 𝘥𝘰𝘸𝘯 𝘵𝘩𝘦 𝘳𝘰𝘢𝘥 𝘪𝘧 𝘪𝘵 𝘸𝘪𝘭𝘭 𝘳𝘦𝘲𝘶𝘪𝘳𝘦 𝘵𝘢𝘬𝘪𝘯𝘨 𝘵𝘩𝘦𝘮 𝘵𝘩𝘳𝘰𝘶𝘨𝘩 𝘵𝘩𝘦 𝘯𝘦𝘸 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘱𝘳𝘰𝘤𝘦𝘴𝘴; 𝘵𝘩𝘦 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭𝘭𝘺 𝘣𝘶𝘳𝘥𝘦𝘯𝘴𝘰𝘮𝘦 𝘯𝘢𝘵𝘶𝘳𝘦 𝘰𝘧 𝘵𝘩𝘦 𝘢𝘥𝘷𝘦𝘳𝘴𝘦 𝘦𝘷𝘦𝘯𝘵𝘴 𝘳𝘦𝘱𝘰𝘳𝘵𝘪𝘯𝘨 𝘴𝘺𝘴𝘵𝘦𝘮 𝘵𝘩𝘦 𝘭𝘢𝘸 𝘸𝘪𝘭𝘭 𝘳𝘦𝘲𝘶𝘪𝘳𝘦 𝘵𝘦𝘴𝘵 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘦𝘳𝘴 𝘵𝘰 𝘮𝘢𝘪𝘯𝘵𝘢𝘪𝘯; 𝘢𝘯𝘥 𝘵𝘩𝘦 𝘤𝘰𝘯𝘤𝘦𝘳𝘯 𝘵𝘩𝘢𝘵 𝘯𝘦𝘸 𝘶𝘴𝘦𝘳𝘴 𝘧𝘦𝘦𝘴 𝘢𝘱𝘱𝘭𝘪𝘦𝘥 𝘵𝘰 𝘓𝘋𝘛𝘴 𝘤𝘰𝘶𝘭𝘥 𝘱𝘳𝘦𝘷𝘦𝘯𝘵 𝘮𝘢𝘯𝘺 𝘭𝘢𝘣𝘴 𝘧𝘳𝘰𝘮 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘪𝘯𝘨 𝘢𝘯𝘥 𝘰𝘧𝘧𝘦𝘳𝘪𝘯𝘨 𝘵𝘩𝘦𝘴𝘦 𝘵𝘦𝘴𝘵𝘴.” 

CGI’s response: Considering that the results of many clinical genetic or genomic tests can have as much or even more clinical impact on patients as the riskiest of prescribed drugs, we consider it appropriate and necessary for clinical genetic/genomic tests to have the same robust oversight that pharmaceuticals have in the USA. The reporting to the FDA of adverse events in drug administration is critical for the improvement and protection of population health. The reporting of adverse events for clinical genetic and genomic tests is equally important, since many genetic/genomic tests guide patient care pathways, conclude diagnostic odysseys, guide drug therapy, lead to irreversible organ removal, and can result in medically advised termination of pregnancies. It would be ludicrous to suggest that the FDA cease its oversight of pharmaceuticals in the USA because it is too burdensome, time consuming, expensive or inhibits innovation. It is equally ludicrous to allow an equally impactful healthcare sector to not be held to the same standards as the pharmaceutical industry because it’s just “too hard” or expensive. The market will adjust to the increased costs of FDA regulated genetic/genomic testing, and overall cost savings are likely to be realized by the healthcare system since fewer patients will be clinically mismanaged. With accurate and clinically efficacious genetic and genomic tests, Precision Medicine might finally consistently deliver on its lofty promises.

CGI’s response: 𝗪𝗼𝘂𝗹𝗱 𝘁𝗵𝗲 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁 𝘁𝗼 𝗽𝗮𝘆 𝗙𝗗𝗔 𝘂𝘀𝗲𝗿 𝗳𝗲𝗲𝘀 𝗳𝗼𝗿 𝗮 𝗴𝗲𝗻𝗲𝘁𝗶𝗰/𝗴𝗲𝗻𝗼𝗺𝗶𝗰 𝘁𝗲𝘀𝘁 𝗿𝗲𝗮𝗹𝗹𝘆 𝗯𝗲 𝘁𝗼𝗼 𝗲𝘅𝗽𝗲𝗻𝘀𝗶𝘃𝗲 𝗳𝗼𝗿 𝗹𝗮𝗯𝘀? Yes, probably for labs that are already skimping on quality. But not for well run labs. For comparison, the reimbursement of different genetic/genomic tests range from $150-$15,000 per test, and most labs are running between 50 to 3,500 tests a day. DNA sequencing instruments cost between $275,000 to $850,000. The cost of sequencing instruments is minor compared to the cost of the reagents and staff needed to run them. So labs are accustomed to big ticket expenses. So with that in mind, here’s the FDA fees labs are trying to argue are too costly for them (to keep patients safe):

*$5,672 annually for registration fees

*$12,745 per application per test for 510(k) (most common for genetic and genomic tests, which are usually copy-cat tests, e.g. BRCA sequencing)

*$374,858 for Companion Diagnostic (CDx) labeling claim or other high-risk testing (e.g. FoundationOne CDx)

https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa

𝗖𝗚𝗜’𝘀 𝗙𝗶𝗻𝗮𝗹 𝗧𝗵𝗼𝘂𝗴𝗵𝘁𝘀:  If laboratories are already resourcing internal quality control and assurance programs and performing thorough analytical and clinical validations before they launch tests (and as part of each test update), then the added burden of FDA approval and adverse event reporting should be only a small fraction of laboratories’ internal quality assurance expenditures. Since delivering accurate and reliable genetic/genomic tests is expensive for laboratories, laboratories that cannot afford to demonstrate accuracy and reliability to the FDA very likely do not have the means to provide accurate and reliable testing.

This regulation has been long overdue and we hope that the VALID Act passes in order to give the FDA oversight of clinical genetic and genomic tests. However, one major concern is that the VALID act as it is presently written will grandfather in currently existing LDTs, including those tests with unproven clinical accuracy and validity. Therefore, the Center for Genomic Interpretation expects to continue to work with health insurance payers through the Center’s ELEVATEGENETICS initiative to protect their plan members from harmful genetic and genomic tests even long after the hoped for passing of the VALID Act.

CONTACT CGI TODAY: Contact us today to learn more about how we can help you, your organization, your plan members and your patients. Call (801) 810-4097 and visit genomicinterpretation.org. Please email truth-in-genomics@genomicinterpretation.org to sign up for our monthly newsletter to stay up to date with the rapidly evolving  genetic and genomic testing space!

####

The Center for Genomic Interpretation – www.genomicinterpretation.org

The Center for Genomic Interpretation (CGI) is an independent 501(c)(3) nonprofit organization with the mission to save and improve lives through encouraging careful stewardship of clinical genetics, genomics and precision medicine. Too frequently the precision medicine goals of patients and their providers are unknowingly thwarted by inaccurate or ineffective genetic or genomic testing. We facilitate the realization of value from among the confusing scramble of the new precision medicine era. The CGI team consists of clinical genetics and genomics scientific leaders, healthcare policy veterans, experienced business professionals, and others dedicated to helping stakeholders achieve the vision and promise of precision medicine.  CGI offers a range of programs and services targeted to all stakeholders including patients, providers, payers, pharmaceutical developers, policy makers and laboratories.