Laboratory Notices

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2019

February 2019

BloodspotSM Amino Acids and BloodspotSM Fatty Acids Updates

Genova Diagnostics has enhanced the BloodspotSM Amino Acids 11 Profile #3502, BloodspotSM Amino Acids 20 Profile #3503, and the BloodspotSM Fatty Acids Profile #3511 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:

  • Each report will include an algorithm-based nutritional needs assessment. Nutrient needs will be categorized as high, moderate, and low, based on the individual test results.
  • Each nutritional need category will be accompanied by a potential dosage range that can be used as a starting place to guide personalized nutritional intervention.

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

January 2019

Introducing PCR Parasitology

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:

  • Blastocystis spp. with reflex subtyping 1-9
  • Cryptosporidium spp.
  • Cyclospora cayetanensis
  • Dientamoeba fragilis
  • Entamoeba histolytica
  • Giardia

The GI Effects upgrade also includes several ease of use report enhancements:

  • The microscopic O&P results section now contains an extensive list of positive and negative findings
  • Commensal and Biomarker Clinical Association Charts have been moved to the end of the report
  • Add-on markers are consolidated into fewer pages

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:

  • 6 PCR targets including Blastocystis subtyping 1-9
  • Microscopic O&P, including an extensive list of positive and negative findings
  • Macroscopic exam for worms
  • Bacterial culture and sensitivities
  • Yeast culture and sensitivities
  • KOH prep for yeast
  • Add-ons available: Clostridium difficile, Campylobacter spp., Shiga toxin Escherichia coli, Helicobacter pylori stool antigen

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Allergy Testing Updates

Effective December 17, 2018, Genova Diagnostics has updated our allergy pricing and combination offerings.

Our allergy updates include:

  • Lower Cash Pricing
  • Simpler Requisitions
  • Updated Allergy Combinations (see the chart below)
Part # Profile Name
1000 IgE Food Antibodies (19 IgE foods)
1001* IgG Food Antibodies (87 IgG foods + Total IgE)
1002* IgG Vegetarian
1003 IgE Inhalants (14 IgE inhalants + Total IgE)
1004 IgE Molds (15 IgE molds + Total IgE)
1005* IgG Spices (24 IgG spices + Total IgE)
1006 Celiac + Gluten Sensitivity

* Not available in NY

For more information on our full line of Allergy testing, please contact your account management team at 800.522.4762.

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2018

December 2018

ION® and TRIAD® Updates

Genova Diagnostics has enhanced our ION® and TRIAD® reports 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:

  • Each report will include an algorithm-based nutritional needs assessment. Nutrient needs will be categorized as high, moderate, and low, based on the individual test results.
  • A "General Supplement Ranges" page will be included with each report to give clinicians additional insight into nutrient ranges often used to support optimal functional need.

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Introducing PCR Parasitology

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:

  • Blastocystis spp. with reflex subtyping 1-9
  • Cryptosporidium spp.
  • Cyclospora cayetanensis
  • Dientamoeba fragilis
  • Entamoeba histolytica
  • Giardia

The GI Effects upgrade also includes several ease of use report enhancements:

  • The microscopic O&P results section will now contain an extensive list of positive and negative findings
  • Commensal and Biomarker Clinical Association Charts will be moved to the end of the report
  • Add-on markers will be consolidated into fewer pages

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:

  • 6 PCR targets including Blastocystis subtyping 1-9
  • Microscopic O&P, including an extensive list of positive and negative findings
  • Macroscopic exam for worms
  • Bacterial culture and sensitivities
  • Yeast culture and sensitivities
  • KOH prep for yeast
  • Add-ons available: Clostridium difficile, Campylobacter spp., Shiga toxin Escherichia coli, Helicobacter pylori stool antigen

Download Gut Pathogen Profile Sample Report

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Vitamin D

As of December 3, 2018, the reporting for Vitamin D, as part of the NutrEval FMV (#3000), NutrEval Plasma (#3001), the ONE FMV (#3200), the ONE Plasma (#3201), the CV Health Profile (#3700), the CV Health Plus Genomics (#3706), the Vitamin D Profile (#3517), and the Hormonal Health Profile (#4000) 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.

  • Deficiency <20 ng/mL
  • Insufficiency 20-29 ng/mL
  • Sufficient 30-100 ng/mL
  • Recommended 50-80 ng/mL
  • Excessive >100 ng/mL

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.

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

November 2018

Melatonin and Estrone Update Lab Notice

The reference ranges for Estrone (salivary), Estrone (serum) and Melatonin (salivary) profiles have been updated due to a change in methodology.

Serum Estrone Profile(s)
ProductID
Hormonal Health 4000
Salivary Estrone Profile(s)
ProductID
Menopause 4101
Menopause Check Plus 4104
Menopause Plus 4100
One Day Hormone Check 4106
Melatonin Profile(s)
ProductID
Menopause Plus 4100
One Day Hormone Check 4106
Rhythm Plus 4102
Male Hormones Plus 4105
Comprehensive Melatonin Profile 4108
Menopause Plus (UK) END14
Male Hormones Plus (UK)END17
Rhythm Plus (UK) END11
Melatonin Profile (UK) END09
October 2018

Updates to Organix®

Genova Diagnostics has updated all Organix®, profile reports as of October, 19, 2018. These tests include an algorithm to assist with clinical interpretation and pattern recognition.

What you can expect from these updates:

  • Each report will include an algorithm-based nutritional needs assessment. Nutrient needs will be categorized as high, moderate, and low, based on the individual test results.
  • Nutrient needs based on the algorithm will be accompanied by a dosage range that is adjusted for the three age ranges (2-5 years old, 6-12 years old, 13-Adult).

*Organix® Dysbiosis Profile - Urine will not be included in this update.

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Update to Zonulin Testing

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.

  1. Scheffler L, et al. Widely Used Commercial ELISA Does Not Detect Precursor of Haptoglobin2, but Recognizes Properdin as a Potential Second Member of the Zonulin Family. Front Endocrinol. 2018;9:22.
  2. Chen JY, et al. Properdin: A multifaceted molecule involved in inflammation and diseases. Mol Immunol. 2018.

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Vitamin D Update

As of October 15, 2018, the methodology for Vitamin D, as part of the ION, ION with 40 Amino Acids, Cardio/ION, and Fat-Soluble Vitamins profiles, has been changed to chemiluminescent immunoassay. The Diasorin Liaison 25 OH Vitamin D Total Assay is certified by the CDC Vitamin D Standardization-Certification Program (CDC VDSCP). This change in methodology will accompany a minor reference range change. We will only be reporting total Vitamin D, and no longer will report both D2 and D3 separately. The clinical interpretation of this marker remains the same.

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

June 2018

Cortisol Awakening Response Update

Genova Diagnostics is updating the calculations within our Cortisol Awakening Response profiles. These calculation updates may impact the turnaround times for the following tests by approximately 5–7 business days:

Product ID
Cortisol Awakening Response (CAR) #4307
Male Hormones Plus™ with Cortisol Awakening Response #4105
Adrenocortex Stress Profile with Cortisol Awakening Response #4308
Rhythm Plus™ with Cortisol Awakening Response #4102
One Day Hormone Check™ with Cortisol Awakening Response #4106
Menopause Plus™ with Cortisol Awakening Response #4100

Once the calculations have been complete, Genova will release updated results for all impacted tests with an overview of how results may have changed based on the calculation update.

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Bone Resorption Assessment

Genova Diagnostics is experiencing delays in our Bone Resorption 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:

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Updates to ION® and Organix® Reports

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 June 19, 2018, and will be available for the ION Profiles by July 15, 2018.

What you can expect from these updates:

  • Each report will include an algorithm-based nutritional needs assessment. Nutrient needs will be categorized as high, moderate, and low, based on the individual test results.
  • A "General Supplement Ranges" page will be included with each report to give clinicians additional insight into nutrient ranges often used to support optimal functional need.

*Organix® Dysbiosis Profile - Urine will not be included in this update.

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

April 2018

Salivary Progesterone Reference Range Change

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
Menopause Plus™ #4100
Menopause™ #4101
Rhythm Plus™ #4102
Rhythm™ #4103
Menopause Check Plus™ #4104
One Day Hormone Check™ #3100

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Cortisol Awakening Response (CAR)

Announcing the addition of the Cortisol Awakening Response (CAR) to our salivary cortisol testing options beginning April 17.

Clinicians will have three cortisol testing options on the Adrenocortex Stress Profile (ASP) and every profile that features the ASP (Rhythm Plus, Menopause Plus, Male Hormones Plus, and One Day Hormone Check):

  • CAR: Three awakening cortisol samples and one nighttime cortisol to help clinicians evaluate HPA axis resiliency. Isolated evening cortisol is associated with insomnia and chronic disease.
  • ASP: Four-point diurnal cortisol to give insight into cortisol's natural circadian rhythm to help clinicians address specific daily stressors.
  • ASP with CAR: Six total samples which combine to offer the most comprehensive evaluation of cortisol and the HPA axis.
CAR ASP ASP with CAR
Waking X X
30 min post waking X X
7:00AM-9:00AM X X X
11:00AM-1:00PM X X
3:00PM-5:00PM X X
10:00PM-12:00AM X X X

The new ASP profile report has been graphically updated. There is no methodology or reference range update.

If you have questions regarding what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Cortisol Awakening Response
March 2018

7 ml Na-EDTA Tube Change

Due to a supply issue with our vendors we are switching the 7 ml Na-EDTA blue top tube with a 7 ml blue top K2 EDTA tube in the following specimen collection packs:

Product ID
NutrEval® FMV Profile #3000
NutrEval® Plasma Profile #3001
ION® Profile #3100
ION Profile with Amino Acids 40 #3102
Cardio/ION Profile #3104
ION Pediatric Profiles #3100
Elemental Analysis #3528

This change will have no effects on any results or procedures associated with the profiles. We apologize for any inconveniences and very much appreciate your continuing trust in Genova Diagnostics.

January 2018

8-hydroxy-deoxyguanosine (8-OHdG)

As of January 15, 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.

If you have questions regarding this change or what it means for your patients, please contact us at 800.522.4762 to schedule a free consultation with one of our clinicians on staff.

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2017

December 2017

New GI Effects® Reporting Enhancements

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.

November 2017

Important Notification about Our Updated US Fee Schedule

In our continuous mission to provide you with the highest quality products and services, we are implementing price changes on select tests/profiles. The new pricing will take effect on December 1st, 2017. Please contact us at 800-522-4762 or contact your Sales Representative if you need a copy of the new Fee Schedule.

October 2017

Now Offering the 3-Hour SIBO Breath Test

We are pleased to announce the immediate availability of the addition of a 3-hour Small Intestinal Bacterial Overgrowth (SIBO) panel, offering new clinical results interpretation, while continuing to offer clinicians an enhanced 2-hour SIBO panel.

New collection packs will now accommodate clinician choice for either a two or three hour sample collection.

Clinicians may now choose the option of selecting a 2- or 3- hour SIBO assessment. 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 updates reflect the current state of scientific understanding related to SIBO diagnostics and results interpretation – and are designed to optimize management of the symptomatic patient.

New updates have been made to the sample report, the commentary, and the SIBO web page, which now includes an updated collection video.

Lp-PLA2 (PLAC) Assay and Reference Range Change

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.

September 2017

Introducing the 3-Hour SIBO Breath Test

Starting October 16, 2017 Genova Diagnostics will now offer the addition of a 3-hour Small Intestinal Bacterial Overgrowth (SIBO) panel, offering new clinical results interpretation, while continuing to offer clinicians an enhanced 2-hour SIBO panel.

New collection packs will now accommodate clinician choice for either a two or three hour sample collection.

New SIBO Report Design & Test Result Interpretation

Genova's SIBO Panels have been updated to reflect the current state of scientific understanding and clinical teaching. Reports for samples received after October 15, 2017 will now include new:

  • Reporting graphics
  • Hydrogen and methane expected values
  • Actual collection times and time intervals based on patient reported time of sample collection
  • Updated report commentary featuring new test result interpretation guidelines

Adrenal Stress Test Discontinuation

In order to provide the highest value testing, we have made the decision to discontinue the Adrenal Stress Test (0243).

Please note that while Adrenal Stress is being discontinued, the Adrenocortex Stress Profile (4300) is an excellent alternative profile that offers convenient at home, salivary assessment of the key stress hormones, Cortisol and DHEA.

The last day to order the Adrenal Stress Test collection pack is Friday, September 29, 2017. The last day test submission to the laboratory will be accepted is Monday, October 30, 2017.

August 2017

Update to IgG Food Antibodies Profile Commentary

As part of our ongoing commitment to excellence in laboratory testing, we are pleased to announce a commentary update to the IgG Food Antibodies Profile beginning September 6, 2017. The commentary on the IgG Food Antibody test report will now discuss the four phases of an Elimination Diet (Preparation, Elimination, Reintroduction, and Long-Term Management).

The updated commentary on the report section of the IgG Food Antibodies Profile will also provide helpful hints and tips to maximize the success of an Elimination Diet and will review nutrients and botanicals to support gut barrier function.

Please contact us at 800.522.4762 with any questions. A second announcement with the updated commentary will be included with the launch on September 6, 2017.

Final Notice Regarding the Updated Collection Method for NutrEval® and Elemental Analysis

Beginning Monday, August 14, 2017, we will fully convert to the new NutrEval® FMV, NutrEval® Plasma, and Elemental Analysis collection method. Please pay careful attention to 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.

July 2017

Important Updates Related to Elemental Analysis Collection Conversion

Beginning August 14, 2017, we will fully convert to the new Elemental Analysis collection method; Elemental Analysis samples that arrive using the old collection method will NO LONGER BE ACCEPTED after this date.

Check Your Box For the New Label

Elemental Analysis Label SampleThe Elemental Analysis boxes must include the new label and utilize the new collection method for order processing to occur after the August 14th deadline.

Please discard any collection packs that do not include the new label and log in to your MYGDX account to order new Elemental Analysis collection packs.

NutrEval® FMV and Plasma Box Conversion Deadline Fast Approaching

Beginning August 14, 2017, we will fully convert to the new NutrEval collection method; NutrEval samples that arrive using the old collection method will NO LONGER BE ACCEPTED after this date.

To further simplify the conversion, we've added step-by-step specimen collection videos to our NutrEval FMV and NutrEval Plasma web pages (you can also order updated NutrEval packs from those pages).

Check Your Box Design

Redesigned NutrEval BoxThe NutrEval FMV and NutrEval Plasma boxes must match the adjacent image for order processing after the August 14th deadline.

If you need to order updated NutrEval Plasma or NutrEval FMV collection packs, please place an order in MYGDX.

May 2017
April 2017

Updates for the Elemental Analysis Profile

We've Updated the Collection Process for Elements

The Elemental Analysis Profile is changing. The table below outlines the specimen matrix updates. Additionally, the collection process is being simplified. See the below corresponding box descriptions and instructions for more details.

New Collection Process LabelWe have created a collection update reminder label for Elemental Analysis collection boxes. When you see the reminder label, simply follow the collection process instructions included within the labeled box.

If you DO NOT see the update reminder label on your Elemental Analysis box, follow the collection process included within that test box.

Specimen-Matrix Updates

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.

If you have questions regarding this change or what it means for your patients, please contact us at 800.522.4762 to speak with one of our Client Services Representatives.

Specimen-Matrix Updates

Important Updates to NutrEval®

We've Updated the Collection Process and Designed New NutrEval® Boxes

Redesigned NutrEval BoxUpdated blood collection and processing steps will be implemented for our NutrEval family of testing. To facilitate this update, we have designed a new NutrEval box.

The collection process will be aligned with the NutrEval package you are using. This update is reflected in the following tests:

  • NutrEval® FMV
  • NutrEval® Plasma Amino Acids

Collection Process Corresponds to your NutrEval Box Design

Old NutrEval Box If you're using our original NutrEval FMV or Plasma box design, use the collection process detailed on the instructions included within the box.


Redesigned NutrEval Box If you're using our new NutrEval FMV or Plasma box design, use the NEW collection process detailed on the instructions included within the box.

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.

Easter Observance – Accounts Receivable Business Office Closed Monday, April 17

In observance of the upcoming holiday, our Accounts Receivable Business Office will be closed on Monday, April 17th, 2017, and will reopen on Tuesday, April 18th, 2017.

If you need assistance unrelated to billing, our Client Services Team will be available on April 17th and can be reached at 800.522.4762.

Shipping Schedules not Affected by the Upcoming Easter Holiday

Please be advised that your shipping schedules will not be affected by the upcoming Easter holiday on 16 April.

Our Receiving Departments will be open on the following days:

  • Friday, 14 April
  • Saturday, 15 April
  • Monday, 17 April

Our International Team will also be unaffected by the holiday and will be available during our standard Monday-Friday US/ET business hours.

Please email us at intl@gdx.net with any questions; we're happy to assist you.

January 2017

Important Information Related to Salivary Cortisol Testing

Effective January 16, 2017, due to a vendor change, we will begin measuring salivary cortisol using Salimetrics Salivary Cortisol Immunoassay Kit (EIA). Per the FDA, this kit is for in vitro diagnostic use. The diurnal pattern and clinical interpretation will remain the same; however, reference ranges will change.

Impacted tests include:

  • Adrenocortex Stress Profile
  • Menopause Plus
  • One Day Hormone Check
  • Rhythm Plus
  • Male Hormones Plus
  • Salivary Cortisol (this is a stand-alone test)

The diurnal pattern depicted on our report graphics will remain exactly the same. Values that are below the detection limit of the assay will be reported as: < 0.007. The reference ranges will change and are based on a healthy cohort of individuals with normal diurnal cortisol patterns and DHEA results.

When performing follow-up testing, result comparison can be made by assessing the relative placement of the result value in relation to the reference range for historic and new reporting.

If you have questions regarding this change or what it means for your patients, please contact us at 800.522.4762 to schedule a free consultation with one of our clinicians on staff.

Platform Change for Celiac and Gluten Sensitivity Panel

Effective January 3, 2017, a portion of the Celiac and Gluten Sensitivity Panel will run on a new, more automated platform, Phadia 250. Phadia 250 is an FDA-cleared fluorescence enzyme immunoassay (FEIA). New reference ranges will be provided by the manufacturer, however report algorithms and clinical interpretation of the test will remain the same.

Minor changes to the language and graphics on the Celiac and Gluten Sensitivity Panel will occur. Instead of reporting "weak positive" results, Phadia 250 will report "equivocal" and this result will be represented with a colorimetric change to yellow on the report. "Equivocal" will signify that results fall within the intermediate range and require further investigation. Additionally, the graphic algorithmic tree will also reflect the language change of "equivocal or positive" to represent how to proceed with further work up required for diagnosis.

Please note that the isolated markers of total IgA and the reflex measurement of Anti-EMA are not available on Phadia 250 and will continue to be run using the previous platform.

If you have any questions related to this upgraded platform, please call us at 800.522.4762.

Happy New Year!

Please make a note of the upcoming holiday hours and closures, by laboratory department, as we observe the New Year holiday.

Client Services Department
  • Closing at 4 PM EST on Friday, December 30
  • Closed all Day on January 2
Laboratory
  • Closed all day on January 2
Account Receivable Business Office
  • Closed all day on January 2

Please scroll down to see our December Holiday Schedule.

We Wish You a Happy and Healthy New Year!

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Laboratory Notices 2016

December 2016

Holiday Schedule

Please make a note of the upcoming holiday hours and closures, by laboratory department, as we observe the upcoming holidays.

Client Services Department
  • Closing at 4 PM EST on Friday, December 23
  • Closed all day on December 26
  • Closing at 4 PM EST on Friday, December 30
  • Closed all Day on January 2
Laboratory
  • Closed all day on December 26
  • Closed all day on January 2
Account Receivable Business Office
  • Closed all day on December 26
  • Closed all day on January 2

We Wish You a Happy and Healthy Holiday Season!

Medicaid of Minnesota and Medicaid of Oregon

Genova Diagnostics will no longer be contracted with Medicaid of Minnesota and Medicaid of Oregon effective 01/15/2017. After this date, Medicaid patients from either of these states should submit the schedule B amount of the test with their kit submission. The schedule B prices for each test can be found on your laboratory fee schedule and online via our EasyPay Assist Tool.

November 2016

Updated Test Requisition Form

We've redesigned the back of the requisition for easy completion. Notable changes are as follows:

  • The back of the requisition now depicts five easy steps to guide patients through completion.
  • A new section below the patient demographic section has been added to capture employment information for specific states relative to lead reporting in the States of Ohio and New Hampshire. These states now mandate all patients to include information employment data when doing testing that evaluates lead levels.

GI Effects® Kit Instruction Changes

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:

  • Reformatted and rewritten instructions to increase ease-of-use and patient compliance
  • New kit tube labels will be utilized to reduce name legibility issues on tubes and decrease rejections
  • Paper surveys have been eliminated; patients are encouraged to visit the Patient Resource Center and complete the online health survey

Amino Acids Discontinuation

In order to provide the highest value testing, we have made the decision to discontinue the Amino Acid Analysis 24 Hour Urine test. Discontinuing tests with very low volume allows us to free up lab equipment and staff that can be used on tests that are in greater demand.

Beginning December 1st, this test will no longer be processed. Kits currently being processed will be completed. Kits received after December 1st will no longer be processed.

We invite you to learn more about our two most popular amino acids tests including Amino Acids Analysis, Plasma, and Amino Acids, Urine. Contact your sales representative for more information.