FAQs

What test options does Variantyx offer? 

We offer testing for rare genetic disorders, reproductive genetics, and precision oncology. All of our tests are based on our whole genome sequencing methodology. Using whole genome sequencing, our Genomic Unity^® test portfolio offers analyses for the genome, exome, targeted panels, and custom gene panels for conditions that occur throughout life, from childhood through adulthood. Our Reproductive Genetic Analyses are diagnostic whole genome tests for a fetus and expectant families. Our Precision Oncology portfolio includes diagnostic whole genome tests for cancer treatment optimization and assessment of cancer predisposition. We also provide personal, proactive genome screening, through Genomic Inform^®.

How can I place an order for testing?

Providers can submit a test requisition form through our Provider Portal or via fax to our Clinical Coordination team. If this is your first order with Variantyx, please contact our Clinical Sales Specialists to get your account set up today via the Contact Us page.

How do I request kits?

To request collection kits, please submit a ticket through our Provider Portal or contact our Customer Service team directly at 617-209-2090. Kits can be sent directly to a provider’s office or a patient’s home.

Where can I find forms to order tests?

Our test requisition forms, informed consents, and other documents are on our Provider Forms and Notes page.

What sample types does Variantyx accept? 

For Genomic Unity^® pediatric and adult testing and OncoAlly^® Hereditary Cancer Analyses we accept blood, saliva, and genomic DNA (gDNA) samples from other labs. Assisted saliva kits are also available.

For IriSight^® CNV Analysis and IriSight^® Comprehensive Analysis – Prenatal we accept direct amniotic fluid, cultured cells, products of conception samples, tissue biopsy, cultured cells, and fetal genomic DNA (gDNA) that has been extracted from another CLIA/CAP certified laboratory.

For OncoAlly^® Solid Tumor Analysis we accept FFPE and normal tissue (or blood) samples that have been extracted from another CLIA/CAP certified laboratory.

What is the policy on parental samples for Genomic Unity^® pediatric and adult tests?

Variantyx accepts biological parental samples as part of duo or trio orders. When placing the order in the Provider Portal, you can request a sample collection kit be sent to the parents’ home(s) for easy at-home sample collection.

If my patient collects their sample for Genomic Unity^® pediatric and adult testing at home, how do they return it?

Our Customer Service team provides return shipping labels on all collection kits sent domestically and upon request for international customers. To learn about returning sample collection kits, please see information on How to Collect and Send a Sample.

What if my patient needs a blood sample, but we don’t do blood draws at our clinic?

Our Clinical Coordination team can send a blood kit to the patient’s home and coordinate with them directly to schedule a mobile phlebotomy appointment through a third party service (available in most cities). If mobile phlebotomy is not available, we will assist with identifying local sites.

What is the process after I place an order?

Once your order is placed, we start working to move testing through the process. If ordered through the online portal, we will follow up with coordinating sample collection kits and other necessary documents. If we received the samples and necessary documents, we will begin processing the sample. If the patient has chosen to use health insurance as their preferred billing method, our Clinical Coordination team will perform a benefit investigation (BI) with the patient’s health plan within 24-72 hours of the order being placed. This will help provide the patient’s estimated financial responsibility.

After the BI is complete, the next step typically involves a prior authorization (PA), as many health plans require a PA for genetic testing services. Team members that specialize in the PA process are here to help every step of the way. If additional information is needed, the Clinical Coordination team will reach out to request the necessary information required by the patient’s health plan.

For patients using self-pay, our Clinical Coordination team will reach out directly to the patient to coordinate payment.

Can I call in a change or update an existing order?

Yes, you can submit a ticket through our Provider Portal or contact our Clinical Coordination team directly via fax or phone at 617-209-2090 to make changes or update an existing order.

How do I send in additional medical records or other documents regarding my patient’s testing?

Additional documentation can be uploaded to a patient’s page on our Provider Portal. You can also contact our Clinical Coordination team directly via fax or phone at 617-209-2090.

How do I “reflex up” to a different analysis for Genomic Unity^® testing for rare disorders?

There is an option to reflex up to a more comprehensive analysis in case the targeted analysis you selected does not yield a diagnosis. This information can be found on page two of our test requisition form. To see a copy of our requisition form, see our Provider Forms and Notes page.

What kind of customer service does Variantyx offer?

Variantyx has dedicated Clinical Coordination and Operations teams that are always here for you and your patients – from the time an order is placed to delivering results. Examples of our services include coordination of sample collection (and recollection, if needed), scheduling mobile phlebotomy services, arranging for pre-test genetic counseling from a third party provider, and assistance with general billing questions. Should you have questions throughout the ordering, interpretation, and delivery process, please don’t hesitate to contact our team directly via the Contact Us page or via phone at 617-209-2090.

How can I make sure my patient gets genetic counseling when they need it?

Some health plans require genetic counseling before providing certain types of genetic testing services. Our Clinical Coordination team will work directly with your office to determine whether genetic counseling can be performed within your facility. Alternatively, we can arrange for pre-test counseling services from a third party provider.

What genes are covered on your tests?

Our tests rely on a whole genome platform, which means ~98% of the genome is covered. However, we may analyze only certain genes in the patient’s data based on the analysis ordered. Genes for each targeted analysis are listed on the individual test pages under Targeted Analyses. Our Genomic Unity^® comprehensive analyses offer a genome-wide assessment of disease-causing findings in the context of the patient’s reported phenotype and an optional group of genes related to secondary findings.

Which variant types can your tests analyze?

Our whole genome sequencing testing can identify all major genetic variants including sequence analysis (single nucleotide variants, deletions/insertions, intronic, regulatory and intergenic variants), copy number variants, duplications/deletions, regions of homozygosity, mobile element insertions, inversions, and aneuploidy, mitochondrial genome sequence analysis with heteroplasmy and large deletions, and short tandem repeat expansion analysis in select genes. However, the WGS data is analyzed and reported depending on the analysis that was ordered. Some tests include only specific analyses, such as for copy number variants, while others include all available analyses. To see the analyses available for a specific test, please review our test menu.

What is your policy on reanalysis?

For our Genomic Unity^® portfolio of tests, we provide one reanalysis of the original sequencing data within 3 years at no cost for our comprehensive analyses including: Genomic Unity^® 2.0, Genomic Unity^® Whole Genome Analysis, Genomic Unity^® Exome Plus Analysis, Genomic Unity^® Exome Analysis, Genomic Unity^® Lightning Genome Analysis – Neonatal, Genomic Unity^® Lightning Genome Analysis – Pediatric, and Genomic Unity^® Lightning Genome Analysis – Standard.

For our IriSight^® portfolio of tests, we provide one reanalysis of the original sequencing data within 2 years of the date of reporting at no cost.

Any new available clinical notes will be used for the reanalysis. Please keep in mind that our databases that inform interpretation are updated quarterly.

If a new variant is identified during reanalysis that requires confirmation (e.g. repeat expansion), the variant will be considered inconclusive. Additional cost may be required to confirm via long read sequencing and a new sample may be required if not enough remains from the original testing. As far as possible, we will provide guidance on the likelihood that the newly identified variant represents a true variant, based on existing false positive rates.

Please note that the state of New York requires that all variants be confirmed and that all samples be destroyed following testing. If you are from the state of New York, any new variant identified by reanalysis will be considered inconclusive and additional cost will be required if you wish to proceed with a new sample for confirmation. As far as possible, we will provide guidance on the likelihood that the newly identified variant represents a true variant, based on existing false positive rates.

What variant types are returned in the Reproductive Genetics Analysis offerings? Are variants of uncertain significance (VUS) findings included?

We report pathogenic or likely pathogenic variants in genes that are associated with the fetal phenotype, or in genes associated with severe, early-onset disorders. Reporting of variants of uncertain clinical significance in genes with high overlap for clinical features are optional and must be selected when ordering.

How do I access my patient’s raw data?

Once the patient has signed our Consent for Genetic Test Results Release form, our Clinical Coordination team will reach out to the provider’s office via secure email with detailed instructions on how to access and download the sequenced data. See our Raw Sequence Data page for more information.

What format is my patient’s raw data provided in?

We provide sequenced data in CRAM or BAM formats aligned to a modified hg38 which excludes alternate contigs, ensuring compatibility with standard hg38 reference files. See our Raw Sequence Data page for more information.

How much does testing cost? 

Cost of testing depends on many factors, such as the test ordered and chosen billing method. For patients with commercial insurance, our Clinical Coordination team will perform a benefits investigation (BI) and contact the patient if their out-of-pocket responsibility is estimated to be $100 or more.

We offer a Patient Assistance Program to all commercially insured patients. For those who qualify, out-of-pocket expenses are limited on a sliding scale based on household size and adjusted annual income relative to Federal Poverty Guidelines. For more information on costs associated with testing, please visit our Billing page.

What type of billing options does Variantyx offer and how do you accept payment?

Variantyx offers insurance (commercial and Medicaid), institutional, and self-pay billing options. We can accept multiple types of payment methods. To learn more, see our Billing page.

What is your turn around time for Genomic Unity^® results? 

Our turn around time for Genomic Unity^® pediatric and adult testing varies depending on many factors. For comprehensive tests, our turn around time is about 10-12 weeks after receiving samples – except for Genomic Unity^® Lightning Genome Analysis tests which have a turn around time of 5-12 days. For targeted analyses (i.e. panels), our turn around time is about 4 weeks after receiving samples. For more information, please contact our Customer Service team directly at 617-209-2090.

What is your turn around time for reproductive genetics analyses results? 

Our turn around time for IriSight^® Comprehensive Analysis – Prenatal is 11 days after receiving samples. Our turn around time for IriSight^® CNV Analysis is 8 days after receiving samples.

What is your turn around time for precision oncology test results?

Our turn around time for OncoAlly^® Solid Tumor Analysis is 14 days after receiving samples. Our turnaround time for OncoAlly^® Hereditary Cancer Analyses is about 2-4 weeks after receiving samples.

How is the report sent?

We send results online or via fax. Our Clinical Coordination team will notify the ordering provider via email once the report has been uploaded to our Provider Portal. Through the portal, the ordering provider and any other additional report recipients noted on the test requisition form will have immediate access to review and download the report.

How do I get another copy of my patient’s original results?

The report can be reviewed and re-downloaded on our Provider Portal.

Can you send my patient’s results to another provider or clinic?

To maintain patient confidentiality, test results will be released only to the ordering healthcare provider or ordering laboratory, and upon the patient’s request, to additional healthcare provider(s) indicated on the test requisition form submitted by the ordering provider. Test results will only be disclosed to others by the patient’s written consent using the Consent for Genetic Test Results Release and/or if demanded by a court of competent jurisdiction.

Can I partner with Variantyx on a research project?

Yes, we are open to research collaborations. Please contact your Clinical Sales Specialist with inquiries or via our Contact Us page.