FAQ

Clinical Services

Q - Can you extract DNA from FFPE blocks?

A - NewGene routinely extracts DNA from clinical samples of tissue, blood, buccal swabs, formalin fixed paraffin embedded (FFPE) tissue and cell pellets.

Q - How much DNA / RNA do you need to run a test?

A - Typically a total of 4µg of genomic DNA for comprehensive gene sequencing tests, Hereditary disorders, and 1µg for targeted mutations, Personalised Medicine tests. 1µg of RNA is required per sample for BCR-ABL monitoring.

Q - How much blood do you need?

A - If you are sending blood foe Hereditary or Haematology testing testing, 4.5ml EDTA blood will yield sufficient DNA for the assay. If you are sending blood for BCR-ABL monitoring, a 2.5 ml sample of whole blood collected in a PAX tube will yield sufficient RNA for the clinical test (1µg).

Q - Who can request a clinical test?

A - In order to ensure that appropriate counselling, support and interpretation are in place referrals can only be accepted from a clinician. NewGene is unable to accept referrals direct from the patient.

Q - How to I make a clinical referral?

A - The referral forms for all tests can be found on the NewGene website. Please send the sample and the completed referral form to the address provided. For more information on the appropriate sample type please see the relevant section of the website.

Q - Do you provide tests to Overseas Customers?

A - NewGene is happy to provide its service to overseas healthcare providers - if you are interested in accessing NewGene tests from overseas please get in touch through the info@newgene.org.uk address.

Q - How will my work be reported?

A - Where clinical tests are provided directly by NewGene clinical tests a formal report will be provided by our State Registered Clinical Scientists within the appropriate turn around time. Paper copies will be sent to the referring Clinician or Pathologist. A copy may also be sent via fax or secure e-mail by arrangement.

For clinical tests that NewGene provide in collaboration with NHS Trusts i.e. Noonan’s Syndrome and some haematology tests, the report may be issued by the collaborating Trust.

Q - Pricing?

A - For information on pricing please contact NewGene through the enquiries@newgene.org.uk address. All prices are provided excluding VAT – please note that VAT is applicable to all UK sales.

Q - How do I pay for a test?

A - That varies depending on the customer:

NHS – Invoices will be sent to the appropriate hospital or Primary Care Trust or Clinical Commissioning Group.

Overseas Customers – Pre-payment is normally required on overseas clinical tests, details will be provided on request.

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Research Services Agena Genotyping

Q - How do I design an assay?

A - Agena offers an assay design tool on their website www.mysequenom.com. It is a simple tool and customers are recommended to do this step themselves. However NewGene is happy to assist with this step. The resulting design file will include all relevant primer information.

Q - What sample types can I work with?

A - The MA4 technology has been successfully used with DNA extracted from whole blood, formalin fixed paraffin embedded tissue, buccal swabs, saliva and fixed cells.

Q - What quantity of DNA is required for the Agena assay?

A - The quantity of DNA will depend on the number of plexes or reactions in the assay. Typically we require DNA at a concentration of 50 ng / µl, NewGene uses 2 µl of DNA per reaction.

Q - Can you do my upstream PCR for the Agena assay?

A - The NewGene approach is very flexible, providing as much or as little upstream preparation as you require. Please discuss your specific requirements with the technical team info@newgene.org.uk

Q - How will I receive my results?

A - The R&D results will be emailed to the customer once genotyping for all results is complete. The results are exported into an Excel spreadsheet, with sample numbers and genotypes listed. If you have access to Agena Typer4 XML, files can be uploaded to your database.

Q - What is the sensitivity of the Agena MassARRAY4?

A - Agena state the sensitivity of the MA4 as 5 - 10%. This means that if the variant is present at 5 – 10% of the level of the wild type the MA4 should be able to detect it.

Q - How do I place an R&D order?

A - Research and development work can be complex and hugely variable. Please contact the team through the info@newgene.org.uk address to discuss your specific requirements. A formal proposal will then be sent detailing the scope of work and the price.

Q - Pricing?

A - For information on pricing please contact NewGene through the info@newgene.org.uk address. All prices are provided excluding VAT – please note that VAT is applicable to all UK sales.

Q - How do I pay for a test?

A - For R&D work a purchase order must be received following the acceptance of a NewGene proposal. In line with the payment schedule agreed in the proposal NewGene will issue an invoice for direct payment.

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answers to your questions across clincial and research services

NewGene Ltd

Bioscience Building, International Centre for Life, Newcastle upon Tyne, NE1 4EP, UK
Tel: +44 (0)191 242 1923 | Fax: +44 (0)191 241 8799 | Email: info@newgene.org.uk | Web:www.newgene.org.uk

NewGene Limited | Company Number: 06735445

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