Laboratory Notices

Effective over the coming weeks, we are streamlining the urine sample collection process for our Comprehensive Urine Elements Profile and Toxic Elements Clearance Profiles.

The multiple large orange collection jugs that were previously sent out automatically will no longer be included. Instead, a First Morning Void urine sample can be collected using any sterile container. For specific cases where larger volume collection is required, these orange jugs can still be requested through Client Services or your Sales Representative.

Important updates are being made to our SIBO specimen collection pack.

• Over the coming weeks, the SIBO collection pack will begin shipping with an extra tube to improve viability of the baseline collection.
• With the addition of the extra tube, the collection instructions have been revised to further enhance the patient experience and support a successful collection.
• Starting Monday, July 26, US clients must order collection packs using drop ship delivery to patients. Paper requisitions will not be included with these orders. At this time this does not apply to UK, International, and Canada SIBO Users.
• Existing SIBO collection packs can still be used and returned to our lab.

We appreciate your cooperation and partnership in delivering exceptional healthcare. For any questions or further assistance, please contact your sales representative.

We are improving our test menu and want to update you on a change. Starting Monday, 1st May, 2023 the Comprehensive Adrenal Stress profile will be ordered, reported, and invoiced as the Adrenal Stress Profile (ASP) with SIgA add-on.

• The reported data, pricing, and available add-ons remain the same.
• Existing collection packs for the Comprehensive ASP can still be used.

Please contact your sales representative or call client services at +44 (0)20 8336 7750 with any questions. Explore the test menu online at www.gdx.net/uk.

We will be discontinuing select profiles due to low volume. If you have already ordered and received a collection pack for one of these profiles, we will accept returned samples up until 28 April, 2023.

• Metabolic Syndrome Profile MET08
• B12 & Folate NUT13
• Ferritin NUT14

We apologize for any inconvenience. Any questions, please contact us at +44 (0)20 8336 7750

Please note that on the ION profile (#3102), testing for alpha- and gamma-tocopherol are not performed in children under the age of 6 due to lack of reference ranges for this patient population.

Please contact client services online at www.gdx.net or 800.522.4762 with questions

After ongoing data analysis following the upgrade of the commensal bacteria methodology to qPCR, the proprietary algorithms for the Total Patient Abundance and Commensal Balance graphics have been refined to improve clinical utility. This commentary change has been applied to all reports released with the new commensal platform. No individual biomarker results have changed.

The following profiles are affected

• GI Effects Comprehensive Profile 2200
• GI Effects Microbial Ecology Profile 2205

Please contact client services online at www.gdx.net or 800.522.4762 with questions

The methodology for the PCR Commensal Bacteria has been updated to qPCR. The reference ranges have been updated accordingly. The names of some of the bacteria have been updated as a result of taxonomy changes and method improvements.

The following profiles are affected

• GI Effects Comprehensive Profile 2200
• GI Effects Microbial Ecology Profile 2205

Please contact client services online at www.gdx.net or 800.522.4762 with questions

Genova Diagnostics will be discontinuing RBC chromium in the following profile immediately:

Elemental Analysis #3528

Chromium is still available in Genova's Comprehensive Urine Element Profile #3527.

Please contact client services online at www.gdx.net or 800.522.4762 with questions.

Genova is streamlining some of our current product offerings to pave the way for the most innovative diagnostic solutions. Moving forward, we will consolidate certain profiles as follows:

The Organic Acids line of products will be consolidated into the updated Organix. Aligning the best of the Organix Comprehensive Profile and the Organic Acids Profile into one profile, the Organix #3301. The New York versions will no longer be available. The new Organix Profile will include all the organic acids reported in the Organic Acids Profile along with the addition of the DNA Oxidative Stress marker, 8-OHdG.

The ION suite of products will combine into the new ION #3102. The CardioION will be replaced with the new ION #3102 and the Cardio Check Profile #3702. The New York versions will no longer be available.

The following products will be discontinued:

1008 Allergix Bloodspot IgG4 Food Antibodies Profile 30

1007 Allergix IgG4 Food Antibodies Profile 90

1009 Allergix IgG4 and IgE Food Antibodies Profile

3400 TRIAD Profile (Combined tests 0011, 0091, 0075)

3401 TRIAD Bloodspot Profile (Comb. tests 0113, 0091, 0076)

3502 Bloodspot Amino Acids 11 Profile

3503 Bloodspot Amino Acids 20 Profile

3504 Amino Acids 40 Profile

3506 Amino Acids 20 Profile

3511 Bloodspot Fatty Acids Profile

3512 Fatty Acids Profile - Erythrocytes

3509 Fatty Acids Profile - Plasma

3520 Coenzyme Q10 Plus Vitamins Profile

3514 Fat-Soluble Vitamins Profile

3607 Lipid Peroxides (TBARS)

3610 DNA/Oxidative Stress Marker (8-OHdG)

3524 Nutrient and Toxic Elements Profile - Blood

3526 Toxic Metals Profile - Whole Blood

Genova offers similar profiles, please visit www.gdx.net.

What to Expect Next

Patient samples for the discontinued products will no longer be accepted after October 8, 2022.

How We Can Help

Please contact us for assistance as needed with outstanding orders or updating your inventory of collection packs. Your Sales or Client Services representative is happy to help you and answer any other outstanding questions. .

Due to global supply-chain issues the Blue-top Amber Tube used in the below collection packs will be temporarily replaced with a Black-top Amber Tube. Either tube will be accepted.

Please contact client services at 800.522.4762 or online if you have further questions.

As of May 31, 2022, the Comprehensive Digestive Stool Analysis (CDSA) and CDSA 2.0 are being rebranded under the GI Effects Stool Profiles product line as the GI Effects Fundamentals (#2209).

Markers evaluating digestion and absorption, inflammation, bacterial metabolites, and bacterial culture are all included. Add-on options such as evaluation for fecal secretory IgA, pathogenic bacterial antigen and toxin assays for symptomatic patients, KOH preparation for yeast, macroscopic exam for worms, and Zonulin Family Peptide will also be available. A new add-on parasitology module offers both microscopic ova and parasite assessment AND the use of PCR to detect select parasites. Please note, some assays are not available in New York.

For more information, please visit the GI Effects Fundamentals product page.

Please call client services at 800.522.4762 for more information.

The Complete Hormones FMV #4200 and Complete Hormones 24 Hr #4202 will be temporarily paused due to manufacturer supply challenges with the assays for urinary androgens, cortisol metabolites, and pregnanediol. The urinary parent estrogens and their metabolites are still available and can be ordered as part of the Essential Estrogens Profile and Estrogen Metabolism, Urine.

Due to low volume Genova Diagnostics will be discontinuing the following tests:

And the following a-la-carte SNPs

All other Genomics Profiles and SNPS are still available. We apologize for any inconvenience.

Please call client services at 800.522.4762 for more information.

Due to low volume, Genova Diagnostics will be discontinuing the following profile:

The last date to submit samples for testing is February 14, 2022. Collection packs are no longer available for order. We apologize for any inconvenience.

Please call client services at 800.522.4762 for more information.

Christmas Hours

• Friday, December 24th: Client Services and Business Offices closed
• Saturday,December 25th: Client Services, Laboratory Support Services, and Business Offices are closed

Shipping

• For 2 DAY shipping, please ship your collection pack by Wednesday, December 22nd. Do not ship on December 23rd.
• For OVERNIGHT shipping, please ship your collection pack by Thursday, December 23rd. Please do not ship on December 24th.

New Year's Hours

• Friday, December 31st: Client Services closes at 5:00 PM ET
• Saturday,January 1st: Client Services, Laboratory Support Services, and Business Offices are closed
• Monday,January 3rd: Client Services, Laboratory Support Services, and Business Offices are closed

Shipping

• For 2 DAY shipping, please ship your collection pack by Wednesday, December 29th. Do not ship on December 30th.
• For OVERNIGHT shipping, please ship your collection pack by Thursday, December 30th. Please do not ship on December 31st.

Beginning November 22, 2021 Genova Diagnostics will no longer report the reflexive Blastocystis subtyping for our suite of GI Effects Profiles:

• GI Effects Comprehensive Profile #2200
• GI Effect Microbial Ecology Profile #2205
• GI Effects Gut Pathogen Profile #2207

When initially added to the profile, it was believed this could add to the rapidly evolving conversation regarding the clinical implications of Blastocystis infection and help to inform treatment decisions.

However, after years of data collection on Blastocystis subtyping powered by Genova's Artificial Intelligence, no obvious patterns emerged as it relates to other biomarkers on the profile, or status of the overall microbiome. With the goal of utmost clinical utility in mind, Genova has decided to discontinue reflex Blastocystis subtyping while continuing to follow ongoing research on the topic. For more information, please see Blastocystis White Paper.

Genova Diagnostics is excited to announce a reconfigured Celiac Profile. The update will include the addition of two new biomarkers, Anti-Tissue Transglutaminase IgG (tTG IgG) and Anti-Deamidated Gliadin IgG (DGP IgG) to further enhance clinical utility and help guide diagnostic decision-making.

The profile will no longer include the Anti-Gliadin IgA and Anti-Gliadin IgG biomarkers due to the discontinuation of those products by the manufacturer. The Celiac & Gluten Sensitivity assessment will be retired on November 22, 2021 and replaced by the new Celiac Profile #1018.

Current Celiac & Gluten Sensitivity collection packs can be used with the new upgraded profile, so there is no need to replace any collection packs.

On September 13, 2021 Genova is launching our new cardiovascular profile, Cardio Check. This new profile will replace the Comprehensive Cardiovascular Assessment and will now include markers for metabolic syndrome such as the Triglyceride/HDL ratio instead of the non-specific marker, fibrinogen.

The reference range for Eosinophil Protein X has been updated on all stool profiles. There is no clinical impact of the numerical changes. Result comparisons will not be possible between the previous and new version. However, comparison may be made by assessing the relative placement of the result value in relation to the reference range for historic and new reporting.

Patient Results Will Now Be Available Simultaneously to Clinicians and Patients

Moving forward, Genova Diagnostics will automatically release all patient test results as soon as they are available, as mandated by the new CURES Act. Clinicians and patients will be able to receive the results at the same time in their corresponding Genova portals- myGDX for clinicians and Patient Resource Center for patients. This change will take place in our portals by the end of this month. Please contact customer service with any further questions at 800.522.4762 or email us at info@gdx.net.

Thank you for your continued business!

Metabolic Analysis Profile (MAP) Change

The name of the Metabolic Analysis Profile (MAP) has been changed to Organic Acids.

Organic Acid Changes

With the upgrade to the NutrEval profile, some analyte changes have been made compared to previous reports. The organic acids arabinose, homogentisic acid, and 2-hydroxyphenylacetic acid are no longer part of the organic acid analysis. These markers have been replaced with D-arabinitol, alpha-hydroxybutyric acid, glyceric acid, glycolic acid, and oxalic acid.

Nutrient & Toxic Element/Element Analysis Profile Change

As part of ongoing assessments into the clinical utility of Genova's nutritional testing, whole blood evaluations for tin exposure will no longer be offered as part of the NutrEval's Nutrient & Toxic Elements add-on or the Elemental Analysis profile.

Comprehensive Urine Elements Change

The "tentative maximal permissible limit" is no longer included in the reference range depiction for certain urine toxic elements on the Metabolomix+ add-on for Comprehensive Urine Elements Profile. These values have limited clinical utility and are no longer supported in the peer-reviewed literature.