Multi Gene Panel Testing By Lifelabs

Increase your Diagnostic Yield Using One of the Curated, Comprehensive, or Custom Panels from LifeLabs Genetics. Genetic testing can deliver much more than ancestry information for the curious. Clinically focused Genetic testing yields data that inform accurate diagnoses for rare diseases, support medical decisions and may change the course of a person’s life.

WHO IS THIS TEST FOR?

 

LifeLabs Genetics offers testing for > 200-panel options.

 

Fixed Panels are best suited for healthcare providers who:

 

• Seek confirmatory diagnostic testing for patients with suspected phenotypes
• Prefer to minimize the likelihood of identifying variants of uncertain significance
• Would like to test only those genes most commonly associated with the suspected phenotype
  

 

The Expanded Panel is best suited for healthcare providers who:

 

• Aim to gain deeper insights into clinically relevant genes
• Have a patient with an unidentified and/or highly heterogeneous phenotype
• Do not have access to whole-exome sequencing
• Have a patient with an identified phenotype and are in search of an affordable clinically-based exome instead of a disease-specific panel

 

Progressive panels are best suited for healthcare providers who:

 

• Have a patient with an unidentified or heterogeneous phenotype, where whole-exome sequencing has already been attempted or was not available
• Have a patient with an identified phenotype, but prefer to test a large number of genes related to the specified clinical indications
• Would like to expand on the fixed content panels currently offered through LifeLabs Genetics or any other provider of genetic testing
• Would like the ability to reflex to a larger data set if their choice in panel comes back negative

These tests do not identify your ancestry.

TIMING

 

• Babies, children, and adults can all benefit from genetic testing depending on the health issues or life events they are facing
• Turnaround times vary by test; results may become available to your physician in 4 to 6 weeks; expedited testing for prenatal cases is also available
• Timing estimates do not include time required for physician appointments, requisitions, consent signatures, sample collection, statutory holidays, or courier/shipping times (samples are analyzed in Toronto or Germany)
  

 

TEST SPECIFICS

 

• Panel testing utilizes next-generation sequencing to achieve optimal coverage of targeted bases
• Fx Panels have >99% technical sensitivity across SNVs
• Ex Panel has >99.6% technical sensitivity
• ProGx Panels have >99.1% technical sensitivity
• Simplified Pricing Structure – Most panels are $1,500 CAD, including CNV analyses

 

RESULTS & REPORTS

 

Reports are sent to physicians only; LifeLabs Genetics cannot share results directly with patients. The ordering physician will receive an email or fax when results become available. Actual results are never shared via email.

Results documentation includes the following:

 

• Test type, date, methodology, result, and interpretation
• Positive result: Indicates a genetic variant was identified in a specific gene and that variant is pathogenic or likely pathogenic (highly likely to be causal of the disease-related condition).
• Uncertain result: Sometimes, gene variants are proven but their significance is not clear. This is stated in the results and discussed with you by your physician. This category of variant is not reported for fetal samples or samples from deceased persons.
• Negative result: If no disease-causing variant is found, genetic changes responsible for the disease or a tendency to have a disease may still exist and cannot usually be fully excluded.

LifeLabs Partners With Bayer Inc. to Offer Clinicians a Complimentary Testing Service to Detect TRK Fusion Cancer

LifeLabs is pleased to announce it has partnered with Bayer Inc. to launch FastTRK, a complimentary clinical testing program for the diagnosis of neurotrophic tyrosine receptor kinase (NTRK) gene fusions in TRK fusion cancer patients in Canada.

Bayer founded the FastTRK program through partnerships with LifeLabs and the Kingston Health Sciences Centre, who are the initial labs that will be providing this centralized testing service. Bayer will cover the full cost of the test regardless of the results, treatment decision, and patient’s insurance coverage until at least the end of 2021.

“We’re pleased to be working with Bayer on this as it supports a common goal among many health care organizations in finding effective tests for patients with severe medical conditions such as cancer,” says Charles Brown, President, and CEO of LifeLabs. “Because this test is for such a rare form of cancer, it represents an exciting innovation that may lead to other treatment options for patients, where previous options have failed.”

Some cancers are caused by specific changes in genes (referred to as ‘genomic alterations’). TRK fusion cancer is caused by the fusion of an NTRK gene with another unrelated gene. TRK fusion cancer can occur in any organ or tissue type in the body, in both children and adults. FastTRK enables clinicians to test their patients’ cancer for the presence of an NTRK gene fusion across all solid tumor types. If an NTRK gene fusion is found, that patient may be eligible for a targeted treatment option.

“As new treatment options are approved to help cancer patients in Canada, in this new era of precision medicine, testing partnerships such as FastTRK are critical bridges to help clinicians identify which of their patients are candidates for specific targeted therapies,” says Dr. Shurjeel Choudhri, Senior Vice President and Head, Medical & Scientific Affairs for Bayer Inc.

Who can get tested through FastTRK?

 

Patients with solid tumors that are metastatic, or when surgical resection is likely to result in severe morbidity, and for whom no satisfactory treatment options are available, meet the criteria to be tested. Testing for NTRK gene fusions should be performed for patients with tumor types known to frequently harbor NTRK gene fusions.

A clinician must request the test. For more information on FastTRK or how to request a test, healthcare professionals can visit www.fasttrk.ca or email fasttrk@bayer.com.

About LifeLabs

 

LifeLabs is Canada’s leading provider of laboratory diagnostic information and digital health connectivity systems, enabling patients and health care practitioners to diagnose, treat, monitor, and prevent disease. We support 20 million patient visits annually and conduct over 100 million laboratory tests through leading-edge technologies and our 5,700 talented and dedicated employees. We are a committed innovator in supporting Canadians to live healthier lives, operating Canada’s first commercial genetics lab and the country’s largest online patient portal, with more than 4.1 million Canadians receiving their results online. LifeLabs is 100% Canadian owned by OMERS Infrastructure, the infrastructure investment manager of one of Canada’s largest defined benefit pension plans. Learn more at lifelabs.com.

 About Bayer

 

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.ca.

Hereditary Cancer Genetic Test | Lifelabs

Approximately 5-10% of all cancers are hereditary. An additional 10-30% of individuals may be at increased risk because they have close family members who also had cancer, suggesting a familial link, even though no specific hereditary link was found.

There are many types of familial cancers. For example, in certain families, women have a higher propensity to develop breast and/or ovarian cancer. This is known as Hereditary Breast and Ovarian Cancer syndrome (HBOC), which is often caused by an inherited mutation in either the BRCA1 or BRCA2 gene (BRCA1/2). Harmful variants in BRCA1/2 may lead to an increased chance of developing other cancers as well, such as a fallopian tube, peritoneal, melanoma, pancreas, and/or prostate cancer. 

More than 2,600 harmful mutations have been found in BRCA1/2.

 

Analysis of hereditary cancer genes involves a step-by-step look through the DNA of each gene for changes, known as mutations. Our panel looks at the 47 more common genes associated with increased risk of developing hereditary breast, ovarian, uterine, colorectal, gastric, prostate, melanoma, and pancreatic cancers. Genetic testing is most commonly performed on blood but can also be performed on saliva, tissue, or banked DNA.

Who Should Consider Testing? 

 

It is estimated that 1/2 of men and 1/3 of women will develop cancer in their lifetime. 5-10% of cancers are hereditary, which means we can tell you more about your risks ahead of time.

Genetic testing may be appropriate if you or a close family member has:

 

• Breast, colorectal, or uterine cancer diagnosed before age 50
• More than one type of cancer
• Cancer in both of a set of paired organs (for example, both kidneys or both breasts)
• Certain types of cancer including ovarian, pancreatic, metastatic prostate, intraductal prostate, medullary thyroid, triple-negative breast or male breast cancer)
• 10+ gastrointestinal polyps
• Breast or high-grade prostate cancer (Gleason score >7)
• Ashkenazi Jewish ancestry

LifeLabs Genetics offers the following more targeted panels, each including pre- and post-test genetic counseling:

 

• BRCA1, BRCA2 panel
• Breast Cancer panel
• Breast and Gynecologic Cancer panel
• Colorectal Cancer panel
• 47 Gene Panel

TIMING:

 

• Once the sample is received at LifeLabs Genetics, the team will schedule a pre-test genetic counseling session for the patient and, optionally, the ordering physician
• Sample analysis by LifeLabs Genetics’ laboratory partner, Invitae, takes 4–6 weeks
• The patient is strongly encouraged to attend a post-test genetic counseling session
• Timing estimates do not include the time required for healthcare provider appointments, requisitions, consent signatures, sample collection, or courier/shipping times

Tuberculosis (TB) Test by Lifelabs

QuantiFERON®–TB Gold Plus (QFT-Plus) is a simple blood test for Tuberculosis (TB), an air-born and highly contagious infectious disease. While TB most frequently affects the lungs (pulmonary TB) it can also cause diseases in any part of the body, such as the lymph nodes, bones, brain, organs, and eyes. TB is a serious disease that kills about 1.5 million people each year worldwide. TB is spread when a person with active, infectious TB disease coughs, sneezes, or spits, releasing droplets containing TB bacteria into the air, which are then inhaled by someone else.

What is Latent TB?

 

Not everyone who is exposed to TB bacteria will develop an infection, and not all of those who become infected will develop symptoms of TB disease, which is why getting tested is so important. Those who are infected but have no symptoms are said to have a latent TB infection (LTBI), while those who do become sick have an active infection.

 If you have latent TB, you do not feel sick but you could become sick at some point if your LTBI becomes an active TB infection. This happens to about 10% of people with untreated latent TB infections, who are otherwise in good health. A greater percentage of people with compromised immune systems, such as those suffering from malnutrition, tobacco users, those with diabetes, and especially those with HIV infection, are at greater risk of developing active TB disease. 

What makes QFT-Plus better than the skin test?

With the QFT test, you only need to visit LifeLabs once to give a blood sample. With the skin test, you need to plan two visits to your healthcare provider: one to administer the test and one to check for results. The QFT-Plus test is better at helping your healthcare provider determine if you have TB, saves you time, and provides more accurate results than traditional skin prick testing.  There are no risks to getting this test done. All you need to do is get blood drawn at a select LifeLabs location in your province.

Who should have the QFT-Plus test?

 

QFT-Plus can be used in place of the skin test and is suitable for anyone who has:

 

1. Had contact with someone known to have TB
2. Been to a country with high rates of TB
3. A weak immune system, such as:
1. Those with HIV infection
2. Those with chronic underlying conditions, including diabetes and kidney disease
3. Organ transplant recipients and others on immunosuppressant drugs
4. Pregnant women
5. The elderly
4. Started some types of medications
   

 

Additionally, people who work with, or are part of groups with high rates of infection, such as IV drug users, or confined populations, such as hospitalized patients, prisoners, and residents of nursing homes can also use this test. QFT-Plus works in people who have been previously vaccinated against TB, and can also be used to confirm a positive skin test result.

How can I get the QFT-Plus test?

 

QFT is available at select LifeLabs locations in Ontario and BC. You must bring a completed test requisition from your healthcare provider.

What will the test show?

 

The QFT-Plus test will help your healthcare provider determine if you have TB. It will show one of two results:

 

• Positive – you will probably have TB. However, your healthcare provider needs to see you before confirming that you have TB
• Negative- you probably do not have TB.
  

 

Occasionally, the results are not clear. If that happens, your healthcare provider may have you take the test again.

Whole Exome Sequencing | Lifelabs

Most relevant in cases with heterogeneous or atypical phenotypes, whole-exome sequencing (WES) combines next-generation sequencing methods with powerful bioinformatics to identify and interpret changes in the protein-coding regions, or exons, of most genes in a single test. WES increases the chances of diagnosing complex genetic disorders and getting to the root cause of disease, faster.

Who Is This For?

 

Atypical or complex findings that may represent a new or rare syndrome 

 

A suspected genetic disorder where the previous testing has been uninformative. Medical answers are likely available only by sequencing the whole exome. Heterogeneous phenotypes, such conditions as:

 

• Epilepsy
• Neurodevelopmental disorders
• Bone diseases
• Metabolic disorders
• Cardiomyopathy
• Complex dysmorphism
• Severe Combined Immunodeficiency (SCID)
• Immunological disorders
• Dementia
• Metabolic disorders
• Autism
• Blindness

 

This test does not identify your ancestry. It is not recommended as a wellness screen, nor as a test to determine conditions for which you or your offspring may be susceptible to.

TIMING: 

 

• Standard, high quality, service turnaround time is 6 weeks
• Prenatal, express service turnaround time is 3 weeks
• Timing estimates do not include the time required for physician appointments, requisitions, consent signatures, sample collection, or courier/shipping times (samples are analyzed in Germany)
•  

TEST SPECIFICS:

 

• The test can be ordered for the proband only (singleton) or with parental and/or other family members (trio)
• Utilizes the Twist Core Exome Plus kit (~36.5mb)
• >98% of targeted bases covered at >20x (>99.5% of the CCDS regions), including +/-20bp exon-intron boundaries
• >99.6% technical sensitivity and >99.8 technical specificity
• CNV analyses by NGS included
• Mitochondrial analyses available as add-ons
• Raw data (.fastq, .bam, or .vcf file formats) and research report available
• Opt-out option available for incidental findings
•  Incidental findings are only reported in the proband

 

Reports are sent to physicians only. LifeLabs Genetics will not share results directly with patients. The ordering physician will receive an email when results become available. Results are never shared via email; results will be made available on the CENTOGENE portal for viewing and downloading.

REPORTS & RESULTS:

 

Results documentation includes the following:

 

• Test type, date, methodology, result, and interpretation
• Positive result: Indicates a genetic variant was identified in a specific gene and that variant is pathogenic or likely pathogenic (highly likely to be causal of the disease-related condition).
• Uncertain result: Sometimes, gene variants are proven but their significance is not clear. This is stated in the results and discussed with you by your physician. This category of variant is not reported for fetal samples or samples from deceased persons.
• Negative result: If no disease-causing variant is found, genetic changes responsible for the disease or a tendency to have a disease may still exist and cannot usually be fully excluded.
• Opt-out option available for incidental findings
•  Incidental findings are only reported in the proband

Mobile Lab Services By Lifelabs | Who is Eligible?

We know not everyone is able to come to one of our Patient Service Centres, so our fleet of mobile services is ready to come to you. Serving thousands of patients every year in their home, or working in partnership with healthcare facilities, retirement homes, and businesses, our mobile lab collection team has a range of services to make lab tests simple and convenient. Our in-home blood collection and specimen pick-up service are available to patients in select provinces who meet certain criteria at the request of a physician.

 

You are eligible for in-home collection and specimen pick up if you reside in a long-term care facility or if are unable to leave your home due to:

 

• physical immobility
• physical/mental hardship and/or pain
• public health risk of spreading communicable diseases such as rubella or chickenpox
  

 

Individuals are not eligible if they are:

 

• able to drive a motor vehicle
• able to arrange transportation for shopping, banking, or other activities
• able and/or have returned to work

How to Arrange an In-Home Lab Visit?

 

Requests for home blood collection and specimen pick up must be made by your healthcare provider. Only requests from physicians and healthcare providers are accepted and any changes to the lab requisition must come from the physician that placed the order. Requests for services from patients or family members will not be accepted.

What is the Cost?

 

For qualifying individuals, there is a nominal fee for physician requested in-home lab service. We are also pleased to offer mobile lab services for long-term care residences and retirement homes. 

How Long Can Service be Booked for?

 

Lifelabs home lab services may be ordered for a maximum of six months at a time. The service will automatically expire at the end of the duration stated in the physician order, or after six months. Service will also expire should you no longer meet the eligibility criteria. Please note that we are unable to request a renewal on a patient’s behalf.

Colorectal Cancer Screening | Lifelabs

Healthcare providers have been encouraged to start with targeted screening for groups at the highest risk of cancer. Routine cancer screening is starting up slowly to keep you and healthcare staff safe, and to help stop the spread of COVID-19. The gradual reintroduction of routine cancer screening is consistent with the Ministry of Health’s directions to gradually start offering services that have been delayed because of COVID-19.

FIT is the recommended screening test for people at average risk* of getting colon cancer in Ontario. FIT is available across the province through Cancer Care Ontario’s organized colon cancer screening program, ColonCancerCheck. FIT is a safe and painless cancer screening test that can be done at home and only takes a few minutes. FIT checks someone’s stool (poop) for tiny amounts of blood, which could be caused by colon cancer and some pre-cancerous polyps (growths in the colon or rectum that can turn into cancer over time).

FIT has many advantages, such as:

 

• It is user-friendly and reduces contact with stool
• You only need to collect one stool sample
• You can eat and take your medications as usual

People at average risk of colon cancer should be screened with FIT every two years. A person is at average risk if they are 50 to 74 years old with no first-degree relative (parent, brother, sister, child) who has been diagnosed with colon cancer.

You can discuss your eligibility for a ColonCancerCheck FIT with your family doctor or nurse practitioner. If you are eligible for a FIT, the test will be ordered for you and LifeLabs will then mail a FIT package to your Ontario mailing address of choice.

 

• If you do not have a family doctor or nurse practitioner, please call Telehealth Ontario at 1-866-828-9213.
• If you are in the North West region or the Hamilton, Niagara, Haldimand Brant region you can visit a mobile screening coach to discuss your eligibility for FIT.
• If you live on a First Nation reserve, you can visit a health center or nursing station for more information.
•  

Your family doctor or nurse practitioner will get a copy of your test result from LifeLabs. Cancer Care Ontario will also mail you a letter with your test result a few weeks after you have returned your completed FIT.

 

How do I return my completed fecal immunochemical test (FIT) sample?

 

It is important to return your completed FIT as soon as possible (within 2 days of taking your sample).

 

• You can mail your completed FIT using the pre-paid yellow return envelope provided in the FIT package.
• You can also drop it off at a LifeLabs Patient Service center – visit the LifeLabs Location Finder (locations.lifelabs.com) for drop-off locations and hours.
• If you live on a First Nations reserve, please contact your health center or nursing station to discuss drop off options.
• If you have questions about how to return your completed FIT, call LifeLabs at 1-833-676-1426