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Due to low volume Genova Diagnostics will be discontinuing the following tests:
All other Genomics Profiles and SNPS are still available. We apologize for any inconvenience.
Please call client services at 020 8336 7750 for more information.
Due to current supply-chain issues for various collection supplies, you may notice slightly different tubes and collection materials in certain collection packs. These changes will not affect testing. Please reference the instructions or contact us if you have questions.
We apologize for any inconvenience.
Please visitour Contact Page if you need more information.
Beginning November 22, 2021 Genova Diagnostics will no longer report the reflexive Blastocystis subtyping for our suite of GI Effects Profiles:
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.
Due to a change in laboratory instrumentation, the Thyroid Plus Profile is being updated. In addition to reference range changes, we are excited to announce new graphic design report enhancements to aid in a clear understanding of thyroid metabolism. The updated reference ranges will also affect the thyroid markers on the Functional Blood Profile. To streamline our offerings the following profiles will be discontinued.
No changes have been made to the collection pack or instructions so there is no need to replace existing collection materials.
Genova Diagnostics is excited to announce a reconfigured Coeliac 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 Coeliac & Gluten Sensitivity assessment will be retired on November 22, 2021 and replaced by the new Coeliac Profile #1018.
Current Coeliac & Gluten Sensitivity collection packs can be used with the new upgraded profile, so there is no need to replace any collection packs.
Effective July 10, 2018, Genova Diagnostics has updated our allergy/antibody pricing and combination offerings.
Our updates include:
| Part # | Profile Name |
|---|---|
| 1000 | IgE Food Antibodies (19 IgE foods) |
| 1001 | IgG Food Antibodies (87 IgG foods + Total IgE) |
| 1002 | IgG Vegetarian |
| 1014 | IgE Inhalants (25 IgE inhalants + Total IgE) |
| 1004 | IgE Moulds (15 IgE molds + Total IgE) |
| 1005 | IgG Spices (24 IgG spices + Total IgE) |
| 1006 | Coeliac + Gluten Sensitivity |
We are pleased to announce the immediate availability of a 2 and 3-hour Small Intestinal Bacterial Overgrowth (SIBO) panel.
Collection packs will accommodate clinician choice for either a two or three-hour sample collection. The 3-hour SIBO panel provides insight into gas levels over a longer period of time and is recommended for patients with slower gastrointestinal transit time or constipation.
The new panel reflects the current state of scientific understanding related to SIBO diagnostics and results interpretation – and is designed to optimise management of the symptomatic patient.
Please visit the SIBO Breath Test webpage to view the sample report, see the available commentary, and a patient-focused specimen collection video.
Genova is excited to announce the release of our new Methylation Panel. The Methylation Panel is an innovative genotypic and phenotypic assessment designed to offer insight into the critical biochemical methylation pathway.
Genova's Methylation Panel measures plasma levels of key amino acids and intermediate metabolites involved in the cycles of methylation, homocysteine transsulfuration, and folate metabolism. Additionally, single nucleotide polymorphisms are analysed using a buccal swab to give insight into genetic predispositions that affect enzymatic activity within these pathways.
Visit the Methylation Panel product page.Genova Diagnostics has enhanced the BloodspotSM Amino Acids 11 Profile, BloodspotSM Amino Acids 20 Profile, and the BloodspotSM Fatty Acids Profile with updated supplement recommendations. These tests include an algorithm to assist with clinical interpretation and pattern recognition. We have been working to update these algorithms, and they have now been implemented in our tests.
What you can expect from these updates:
Genova is NOW OFFERING the addition of PCR parasites to the GI Effects Comprehensive #2200, GI Effects Microbial Ecology Profile #2205, and as part of a brand new Gut Pathogen Profile #2207.
The GI Effects 2200 and 2005 now include 6 PCR targets (replacing EIA) that detect common protozoan parasites:
The GI Effects upgrade also includes several ease of use report enhancements:
Download GI Effects Comprehensive Sample Report
Additionally, this PCR technology is part of a brand new Gut Pathogen Profile. This profile provides a comprehensive evaluation of organisms known to contribute to common GI symptoms including:
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Beginning January 21, 2019, Genova will offer the addition of PCR parasites to the GI Effects Comprehensive #2200, GI Effects Microbial Ecology Profile #2205, and as part of a brand new Gut Pathogen Profile #2207.
The GI Effects 2200 and 2005 will include 6 PCR targets (replacing EIA) that detect common protozoan parasites:
The GI Effects upgrade also includes several ease of use report enhancements:
Download GI Effects Comprehensive Sample Report
Additionally, this PCR technology will be part of a brand new Gut Pathogen Profile. This profile will provide a comprehensive evaluation of organisms known to contribute to common GI symptoms including:
As of December 3, 2018, the reporting for Vitamin D, as part of the NutrEval FMV (NUT06), the ONE FMV (NUT04), the CV Health Profile (MET13), the CV Health Plus Genomics (MET14), the Vitamin D Profile (NUT12), and the Hormonal Health Profile (END15) has been changed in an effort to standardize the reference range between all of our nutritional products, we will be adjusting the reference range for 25-Hydroxyvitamin D to be set at 30-100 ng/mL. This follows a literature analysis into the clinical relevance of particular vitamin D results. We will also be providing commentary on the report to summarize the result ranges based on the Vitamin D Council along with other research. These ranges are listed below.
There is no consensus in the literature regarding optimal levels of 25-hydroxyvitamin D. Higher levels of 25-hydroxyvitamin D may be concerning in some clinical conditions, such as renal failure. Levels below 30 ng/mL are considered insufficient by most medical associations. Results falling outside the reference range will be flagged as abnormal.
A recent research paper published in Frontiers in Endocrinology1 suggested that the zonulin kits from Immundiagnostik (IDK) did not detect zonulin (a precursor of Haptoglobin 2). This issue was further confirmed by the kit manufacturer, Immundiagnostik, in a statement released to clinical laboratories. To the best of Genova's knowledge, the recent Scheffler paper1 has impacted the zonulin assay for many laboratories, including Genova's serum and stool zonulin tests. Because some researchers are conducting studies and have received data from the current zonulin kits, Genova has decided to provide the test for research use only with the manufacturer's suggested name: zonulin family peptide. Here is what we know about the zonulin family peptide that IDK kits detect in serum and stool.
The Scheffler paper suggests that the kits may detect properdin, a protein involved in the alternative complement pathway and inflammation1, 2. Preliminary study results from an external investigator suggest that properdin may be structurally and functionally similar to zonulin.
Genova's unpublished data analysis (of 13,613 tests) demonstrated that the test results of the current stool zonulin kit (now called zonulin family peptide) were strongly and positively associated with stool EPX and sIgA (but not calprotectin). Levels of zonulin family peptide detected by this kit were also associated with a commensal bacterial profile related to intestinal inflammation. In addition, they were also positively associated with stool biomarkers such as fecal PE-1 and cholesterol. Some biomarkers, such as stool fat and short-chain fatty acids, showed "bell-shaped" distributions. High or low levels of the zonulin family peptide were associated with low levels of stool fat and short-chain fatty acids.
Because of the lack of information on the mechanism of action and clinical utility of zonulin family peptide, Genova will not provide support on interpreting the test results. Genova will continue monitoring this issue and provide clients with new information as it becomes available.
Announcing the addition of the Cortisol Awakening Response (CAR) to our salivary cortisol testing options.
Clinicians will now be able to order the Cortisol Awakening Response (CAR) as an alternative or an add on to our Adrenal Stress Profile (ASP) and our Comprehensive Adrenal Stress Profile.
| CAR | ASP (END01) | Comp ASP (END02) | |
|---|---|---|---|
| Waking | X | Add-on | Add-on |
| 30 min post waking | X | Add-on | Add-on |
| 7:00AM-9:00AM | X | X | X |
| 11:00AM-1:00PM | Add-on | X | X |
| 3:00PM-5:00PM | Add-on | X | X |
| 10:00PM-12:00AM | X | X | X |
| sIgA | Add-on | Add-on | X |
Each ordered collection pack will have the option to add on the CAR or ASP tests to convert the four-point test to a six-point test as shown above to offer flexibility in test ordered. The sample collection pack will have all tubes required so you do not need to order add-ons in advance.
Every panel will have the option of adding sIgA.
As part of this update total cortisol will no longer be reported.
The new ASP profile report has been graphically updated. There is no methodology or reference range update.
Genova Diagnostics is experiencing delays in our Bone Resorption: Osteoporosis Risk Assessment test due to a vendor supply issue. Currently, we are anticipating that testing materials will be available in July, and we will work to complete and release results swiftly once supplies are received.
This shortage affects the following test:
Genova Diagnostics is updating our ION® and Organix® reports. These tests include an algorithm to assist with clinical interpretation and pattern recognition. We have been working to update these algorithms, and they will be available for the Organix* Profiles no later than 19 June 2018, and will be available for the ION Profiles by 15 July 2018.
What you can expect from these updates:
*Organix® Dysbiosis Profile - Urine will not be included in this update.
The methodology for salivary progesterone has been updated to EIA. As a result of this change, reference ranges have also been updated.
This change affects the following panels:
| Product | ID |
|---|---|
| Rhythm™ | #END10 |
| Rhythm Plus™ | #END11 |
| One Day Progesterone/Oestradiol | #END12 |
| Menopause™ | #END13 |
| Menopause Plus™ | #END14 |
As of 15 January 2018, the methodology for 8-hydroxy-deoxyguanosine (8-OHdG), as part of the NutrEval®, Optimal Nutritional Evaluation (ONE)™, and Oxidative Stress 2.0 (urine) profiles, has been changed to LC-MS/MS. This change to methodology will accompany a minor reference range change. The clinical interpretation of this marker remains the same.
Orders placed for the GI Effects® Comprehensive Profile and GI Effects® Microbial Ecology Profile on or after December 18 will feature innovative reporting enhancements.
New features include a Commensal Balance infographic designed to provide a more precise view of a patient's commensal bacteria as well as new Clinical Association Charts that allow clinicians to see how patient results compare to commensal bacteria and other biomarker patterns seen in patients with specific clinical conditions.
As of September 28, 2017, measurement of Lipoprotein-associated phospholipase A2 (Lp-PLA2), as part of the CV Health™ Profile and CV Health Plus Genomics™ Profile, will now be performed using the FDA cleared Diazyme Enzyme Activity Assay. The clinical interpretation of this marker remains the same.
With this assay change, there will be a few minor changes to report. There will no longer be a result reflecting 1 standard deviation (previously depicted in yellow), therefore the colorimetric box surrounding the result will be either green or red. The Relative Risk for Cardiovascular Disease will also have a new cut-point based on reference range changes.
We're excited to offer three environmental profiles to our clients in the United Kingdom. These testing options can evaluate possible toxic burden that may be contributing to your patients' chronic symptoms.
Beginning Monday, August 14, we will fully convert to the new NutrEval and Elemental Analysis collection method. Please pay careful attention to the labels on the collection packs you use in the office and allow patients to take home.
Samples that arrive using the old collection method will NO LONGER BE ACCEPTED after this deadline.
Beginning August 14, we will fully convert to the new NutrEval and Elemental Analysis collection methods; NutrEval and Elemental Analysis samples that arrive using the old collection method will NO LONGER BE ACCEPTED after this date.
The NutrEval package must match this image for order processing after the August 14th deadline.
The Elemental Analysis package must match this for order processing after the August 14th deadline.
Beginning July 31, you may begin ordering the following environmental profiles:
The Toxic Effects Core profile provides a comprehensive evaluation of six of the most common classes of toxic chemicals. The Bisphenol A and Volatile Solvents Profiles provides insight into toxic burden by toxicant.
Beginning August 14, we will fully convert to the new NutrEval and Elemental Analysis collection methods; NutrEval and Elemental Analysis samples that arrive using the old collection method will NO LONGER BE ACCEPTED after this date.
The NutrEval package must match this image for order processing after the August 14th deadline.
The Elemental Analysis package must match this for order processing after the August 14th deadline.
The Elemental Analysis Profile is changing. The link below outlines the specimen matrix updates. Additionally, the collection process is being simplified by reducing required sample volume.
We have created a collection update reminder label for Elemental Analysis collection kits. When you see the reminder label, simply follow the collection process instructions included within the labeled kit.
If you DO NOT see the update reminder label on your Elemental Analysis kit, follow the collection process included within that test kit. Please watch for notification in the coming weeks regarding the discontinuation of this kit and related instructions.
Elemental Markers are currently measured in red blood cells (RBCs) specimen matrix. The updated collection process is part of a change to this specimen matrix.
For the complete details on these enhancements, view the linked Specimen-Matrix Updates.
Updated blood collection and processing steps will be implemented for our NutrEval. The label shown here will notify the phlebotomist of the revised test components and instructions. The link below provides further details of the specimen matrix updates.
When you see the reminder label, simply follow the collection process instructions included within the labeled kit.
If you DO NOT see the update reminder label on your NutrEval kit, follow the collection process included within that test kit.
Elemental Markers are currently measured in red blood cells (RBCs) specimen matrix. The updated collection process is part of a change to this specimen matrix. Additionally CoQ10 will be measured in serum.
Highlights of these changes are shown at the Specimen-Matrix Updates link below.
We will be closed for business and unable to accept samples on the following days:
Holiday Shipping Schedule
Please be sure that all samples are received into our premises no later than Tuesday 11th April. We look forward to speaking to you on Tuesday 18th April.
We are relocating our facility to a new space at the end of March, but will remain in New Malden.
Revised requisition and shipping materials can be obtained from our client services representatives at +44 (0)20 8336 7750 or infouk@gdx.net.
Due to a variety of reasons; infrequent requests, lack of validated kits, etc., we are reluctantly discontinuing the following tests:
| Discontinued Profiles* | Recommended Profiles |
|---|---|
| Candida Antibody Profile (Saliva & Serum) | GI Effects® Comprehensive Stool Profile #2200 or Yeast Culture with KOH |
| Aneamia Profile | No Comparable Profile |
| IgE Inhalant Panel | Coming Soon |
* These tests can no longer be processed as of 20th of March.
The Following Test Changes Will Apply as of 27th March
Please view current tests available, including turnaround times.
Exciting Announcements!
While we make these changes, please know you are still our first priority. To show our appreciation for your business, we are pleased to announce we will not be implementing our annual fee increase. Please see the current Fee Schedule.
We are relocating our facility to a new space at the end of March, but will remain in New Malden. During this time, we will take the opportunity to further align our services with our US laboratory for test processing, quality standards and methodology. This will ultimately enable us to better serve your practice and patients, while also allowing us to offer new and exciting tests.
Revised requisition and shipping materials can be obtained from our client services representatives at +44 (0)20 8336 7750 or infouk@gdx.net
Genova Diagnostics will reopen for business on Tuesday, 3rd January 2017.
Please scroll down to see our December Holiday Schedule.
In order to avoid any sample rejections over the Christmas holiday, all samples must be received by Tuesday, 20th December 2016.
Genova Diagnostics will be closed for business from Friday, 23rd December 2016 and will reopen Tuesday, 3rd January 2017.
Please Note: The laboratory will be unable to accept any samples during this period. Tests received after the 20th December 2016 will result in delays and/or sample rejection.
Kit instructions for both One-Day and Three-Day GI Effects® Stool Profiles have been reformatted and will appear in all kits beginning November 22, 2016. Updates include:
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