&lt;h2&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Overview&lt;/strong&gt;&lt;/span&gt;&lt;/h2&gt;
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&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;The Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Full Gene Analysis is a genetic test that examines the entire CFTR gene for mutations associated with cystic fibrosis. This analysis helps diagnose the condition and guides treatment decisions. The test&#39;s composition may vary but typically includes screening for various CFTR mutations. It&#39;s crucial for identifying carriers, confirming diagnoses, and predicting disease severity. Early detection through this comprehensive analysis enables timely interventions and personalized management approaches for individuals with cystic fibrosis.&lt;/span&gt;&lt;/p&gt;
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&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;WHAT IS IT USED FOR?&lt;/strong&gt;&lt;/span&gt;&lt;/h3&gt;
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&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Subsequent testing to detect mutations in individuals clinically diagnosed with cystic fibrosis (CF).&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Detecting genetic variations in individuals with CF atypical presentations (e.g., congenital bilateral absence of the vas deferens or pancreatitis).&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Identifying genetic mutations in cases where targeted variant analysis yields low or unknown detection rates for their ancestral background.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Identifying candidates likely to benefit from cystic fibrosis transmembrane conductance regulator (CFTR) potentiator therapy.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;GENETICS TEST INFORMATION&lt;/strong&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;This test employs next-generation sequencing to identify single nucleotide and copy number variations in the CFTR gene linked to cystic fibrosis (CF).&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Discovering a disease-causing variation can aid in diagnosing CF, predicting outcomes, managing treatment, evaluating recurrence risks, conducting family screenings, and providing genetic counseling for CF.&lt;/span&gt;&lt;/p&gt;
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&lt;h3&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;METHOD NAME&lt;/strong&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Sequence Capture and Targeted Next-Generation Sequencing (NGS) followed by Polymerase Chain Reaction (PCR) and Sanger Sequencing&lt;/span&gt;&lt;/p&gt;
&lt;h3&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;&lt;br /&gt;AVAILABILITY&lt;/strong&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;TBC&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;REPORTING NAME&lt;/strong&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;CFTR Gene, Full Gene Analysis&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;OTHER NAMES&lt;/strong&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;ul&gt;
&lt;li&gt;&lt;span style=&quot;color: #808080;&quot;&gt;NextGen Sequencing Test&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;span style=&quot;color: #808080;&quot;&gt;CAVD (Congenital Absence of the Vas Deferens)&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Congenital Absence of the Vas Deferens (CAVD)&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Cystic Fibrosis (CF)&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Cystic Fibrosis Transmembrane Conductance&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Pancreatitis&lt;/span&gt;&lt;/li&gt;
&lt;/ul&gt;

&lt;h3 id=&quot;SpecimenType-title&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;SPECIMEN TYPE&lt;/strong&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;Varies&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;SHIPPING INSTRUCTIONS&lt;br /&gt;&lt;/strong&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p&gt;&lt;span style=&quot;color: #808080;&quot;&gt;TBC&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;h3&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;SPECIMEN REQUIRED&lt;/strong&gt;&lt;/span&gt;&lt;/h3&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Submit only 1 of the following specimens:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;&amp;nbsp;&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Type:&amp;nbsp;&lt;/strong&gt;Whole blood&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Container/Tube:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Preferred:&amp;nbsp;&lt;/strong&gt;Lavender top (EDTA) or yellow top (ACD)&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Acceptable:&lt;/strong&gt;&amp;nbsp;Any anticoagulant&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Volume:&lt;/strong&gt;&amp;nbsp;3 mL&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Collection Instructions:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;1. Invert several times to mix blood.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;2. Send whole blood specimen in original tube.&amp;nbsp;&lt;strong&gt;Do not aliquot.&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Specimen Stability Information:&lt;/strong&gt;&amp;nbsp;&lt;/span&gt;Ambient (preferred) 4 days/Refrigerated&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&amp;nbsp;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Type&lt;/strong&gt;: Skin biopsy&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Supplies&lt;/strong&gt;: Fibroblast Biopsy Transport Media (T115)&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Container&lt;/strong&gt;/&lt;strong&gt;Tube&lt;/strong&gt;: Sterile container with any standard cell culture media. The solution should be supplemented with 1% penicillin and streptomycin.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Volume&lt;/strong&gt;: 4-mm punch&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Specimen Stability Information&lt;/strong&gt;:&lt;/span&gt; Refrigerated (preferred)/Ambient&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Additional Information&lt;/strong&gt;:&lt;/span&gt; A separate culture charge will be assessed under CULFB / Fibroblast Culture for Biochemical or Molecular Testing. An additional 3 to 4 weeks is required to culture fibroblasts before genetic testing can occur.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&amp;nbsp;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen&lt;/strong&gt;&amp;nbsp;&lt;strong&gt;Type&lt;/strong&gt;: Cultured fibroblasts&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Container/Tube&lt;/strong&gt;: T-25 flask&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen&lt;/strong&gt;&amp;nbsp;&lt;strong&gt;Volume&lt;/strong&gt;: 2 Flasks&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Collection&lt;/strong&gt;&amp;nbsp;&lt;strong&gt;Instructions&lt;/strong&gt;: Submit confluent cultured fibroblast cells from a skin biopsy from another laboratory.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Specimen Stability Information&lt;/strong&gt;:&lt;/span&gt; Ambient (preferred)/Refrigerated (&amp;lt;24 hours)&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Additional Information&lt;/strong&gt;:&lt;/span&gt; A separate culture charge will be assessed under CULFB / Fibroblast Culture for Biochemical or Molecular Testing. An additional 3 to 4 weeks is required to culture fibroblasts before genetic testing can occur.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&amp;nbsp;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Type:&lt;/strong&gt;&amp;nbsp;Amniotic fluid&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Container/Tube:&lt;/strong&gt;&amp;nbsp;Amniotic fluid container&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Volume:&lt;/strong&gt;&amp;nbsp;20 mL&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Stability Information:&lt;/strong&gt;&amp;nbsp;Refrigerated (preferred)/Ambient&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Additional information:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;1. A separate culture charge will be assessed under CULAF / Culture for Genetic Testing, Amniotic Fluid. An additional 2 to 3 weeks is required to culture amniotic fluid before genetic testing can occur.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;strong style=&quot;color: #808080;&quot;&gt;2. All prenatal specimens must be accompanied by a maternal blood specimen;&amp;nbsp;&lt;/strong&gt;&lt;span style=&quot;color: #808080;&quot;&gt;order MATCC / Maternal Cell Contamination, Molecular Analysis, Varies on the maternal specimen.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&amp;nbsp;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Type&lt;/strong&gt;: Chorionic villi&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Container/Tube:&lt;/strong&gt;&amp;nbsp;15-mL tube containing 15 mL of transport media&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Volume:&lt;/strong&gt;&amp;nbsp;20 mg&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Stability Information:&lt;/strong&gt;&amp;nbsp;Refrigerated&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Additional Information:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;1. A separate culture charge will be assessed under CULFB / Fibroblast Culture for Biochemical or Molecular Testing. An additional 2 to 3 weeks is required to culture chorionic villi before genetic testing can occur.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;strong style=&quot;color: #808080;&quot;&gt;2. All prenatal specimens must be accompanied by a maternal blood specimen;&amp;nbsp;&lt;/strong&gt;&lt;span style=&quot;color: #808080;&quot;&gt;order MATCC / Maternal Cell Contamination, Molecular Analysis, Varies on the maternal specimen.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&amp;nbsp;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Type:&lt;/strong&gt;&amp;nbsp;Confluent cultured cells&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Container/Tube:&lt;/strong&gt;&amp;nbsp;T-25 flask&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;strong&gt;Specimen Volume:&lt;/strong&gt;&amp;nbsp;2 Flasks&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Collection Instructions:&lt;/strong&gt;&lt;/span&gt;&amp;nbsp;Submit confluent cultured cells from another laboratory.&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Specimen Stability Information:&lt;/strong&gt;&lt;/span&gt;&amp;nbsp;Ambient (preferred)/Refrigerated&lt;/span&gt;&lt;/p&gt;
&lt;p style=&quot;font-weight: 400;&quot;&gt;&lt;span style=&quot;color: #808080;&quot;&gt;&lt;span style=&quot;color: #33cccc;&quot;&gt;&lt;strong&gt;Additional Information&lt;/strong&gt;:&lt;/span&gt;&amp;nbsp;&lt;strong&gt;All prenatal specimens must be accompanied by a maternal blood specimen;&lt;/strong&gt;&amp;nbsp;order MATCC / Maternal Cell Contamination, Molecular Analysis, Varies on the maternal specimen.&lt;/span&gt;&lt;/p&gt;

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Cystic Fibrosis Transmembrane Conductance Regulator, CFTR, Full Gene Analysis, Varies