Questions?
Answers.

The decision whether bone marrow aspirate should be withdrawn or peripheral blood is sufficient depends strongly on the suspected diagnosis, the suspected entity. In the Diseases/Diagnostics section of our website, we provide the recommended sample material for each suspected diagnosis. In addition, testing from PB for molecular genetics is generally feasible in all myeloid neoplasms.

Yes. Cytomorphology definitely requires EDTA (or citrate); the smear cannot be adequately assessed from sample material with other anticoagulants. Cytogenetics (chromosome analysis) definitely requires heparin as anticoagulant in order not to inhibit cell growth. Therefore, when clarifying unclear suspected cases, it is recommended to send two vials, one with EDTA and one with heparin. For Immunophenotyping, FISH and Molecular genetics, each anticoagulant (EDTA, heparin, citrate) is feasible. Serum (native tubes without anticoagulant) is generally not feasible for leukemia/lymphoma diagnostics. Further information can be found in our Primary Sample Collection Manual, which is available for download on our website.

Yes, for Cytomorphology unstained bone marrow and blood smears should be sent if possible, as fresh smears are of the best quality. Please ensure sufficient drying time (15 min) prior to shipment. For more information, please refer to our Primary Sample Collection Manual, which is available for download on our website.

For primary diagnostics, we require 5-10 ml of PB or BM. For follow-up examinations, especially for MRD monitoring by quantitative PCR, a quantity of 15-20 ml is recommended. For follow-up examinations with the other methods, 5-10 ml are sufficient. Further information can be found in our Primary Sample Collection Manual, which is available for download on our website.

No, for diagnostic purposes the information in our Primary Sample Collection Manual corresponds to the total amount of material required, although here the anticoagulant is relevant for the different methods and must be considered.

Yes, bone marrow biopsies can also be analyzed, although we can only analyze them if sent in NaCl (0.9%) and heparin (500 I.U./ml) and not in formalin. Especially in the case of try tap, the collection of a bone marrow biopsy is useful. Please remember to send peripheral blood along with the bone marrow biopsy. Further information can be found in our Primary Sample Collection Manual, which is available for download on our website.

The biopsies should be sent in NaCl (0.9%) and heparin (500 I.U./ml). We cannot perform studies from biopsies fixed in formalin. For further information, please refer to our Primary Sample Collection Manual, which is available for download on our website.

A few analyses in Molecular genetics can be performed from FFPE material, but the quality and spectrum of available analyses is limited because FFPE DNA is highly fragmented and our analyses are not designed for fragmented DNA. For more information, please see our Primary Sample Collection Manual, which is available for download on our website.

Yes, fresh (non-fixed) tissue can be analyzed. More information can be found in our Primary Sample Collection Manual, which is available for download on our website.

Yes, the analysis of special sample material is possible if there is a specific question. Further information can be found in our Primary Sample Collection Manual, which is available for download on our website.

Yes, you can send the diagnostic material by mail or courier. The delivery should be done within 24 hours, even after 48 hours usually all examinations can be done without quality loss.

Our sample receipt desk is operated Mondays through Fridays from 7am-5pm and Saturdays from 7am-1pm. If the sample cannot be delivered during these business hours, please ship the sample so that it arrives the next morning. Our lab business hours can also be found in the Service section of our website.

The sample should be stored at room temperature until shipment.

On holidays following a working day (Mon-Fri), our laboratory is staffed and accepts samples from 7am-1pm. For acceptance on Sundays and holidays following a weekend or public holiday, please make an appointment by telephone (+49-89-99017-0).

Our laboratory is operated from 7am to 1pm on Bavarian holidays, provided the holiday follows a working day (Mon-Fri). On holidays that follow a weekend or public holiday, we ask you to make an appointment by telephone (+49-89-99017-0).

Yes, we offer a digital order-entry-portal via which examination orders can be transmitted digitally and a corresponding barcode for the blood container to be sent in will be generated for you. Feel free to check our Fastlane under Order-Entry-Portal for more information or contact us by mail (orderentry@mll.com) or phone (+49-89-99017-504).

We need the completed request form. We ask for transmission of the patient consent for research projects, if the patient wants to support the development of diagnostics by research projects of the MLL. If the order includes an investigation of hereditary gene alterations or pharmacogenetics, please ensure that you have informed your patient about the genetic background related to the disease, as well as the possibilities and limitations of molecular genetic testing, as/if it is indicated according to your local jurisdiction.

We ask you to include the patient consent for research projects when we receive samples from your patient the first time. Patient consent is used to support MLL's research activities. However, we perform the diagnostic assignment independent of the patient consent. If the order includes an investigation of hereditary gene alterations or pharmacogenetics, please ensure that you have informed your patient about the genetic background related to the disease, as well as the possibilities and limitations of molecular genetic testing, as/if it is indicated according to your local jurisdiction.

Yes, we perform the diagnostic order regardless of the patient consent for research projects. By providing consent, you are supporting MLL's research activities. If the order includes an investigation of hereditary gene alterations or pharmacogenetics, please ensure that you have informed your patient about the genetic background related to the disease, as well as the possibilities and limitations of molecular genetic testing, as/if it is indicated according to your local jurisdiction.

The consent can be withdrawn or changed in a written form to MLL MVZ GmbH, Max-Lebsche-Platz 31, 81377 Munich, Germany or by fax to +49-89-99017-111.

There are various ways to request additional analyses: You can request analyses digitally via our order entry portal, send us a new request form by fax (+49-89-99017-111) or call us (+49-89-99017-0).

The left over sample material is stored for a maximum of two weeks, but the quality of this decreases with longer storage time, so that the validity of the analyses is affected. Therefore, we kindly ask you to request additional analyses as soon as possible or to make use of the possibility to request step-by-step diagnostics. If a Molecular genetic analysis has already been performed on the sample, the DNA or RNA will be archived for a long time without loss of quality, so that in many cases it will still be possible to request further genetic analyses at a later date.

We follow national (DGHO) and international (ELN, ASH, NCCN) recommendations and specify the appropriate investigations in our Diseases/Diagnostics section for each entity.

We offer step-by-step diagnostics so that if the suspected diagnosis is unclear, we will perform further diagnostics using Chromosomal analysis or Molecular genetics based on the results of Cytomorphology and Immunophenotyping. The indication of the step-by-step diagnostics can be done on our request form.

We offer Cytomorphology, Immunophenotyping, Chromosome analysis, FISH and Molecular genetics. Our request form gives the complete overview of the analyses we offer. Therein the offered analyses for FISH, Molecular Genetics and Immunophenotyping are subdivided according to the suspected diagnosis.

Cytogenetics includes chromosome analysis and FISH. Chromosome analysis provides the complete karyotype/chromosome set and reveals chromosomal changes such as copy number alterations and structural changes. FISH specifically looks for specific chromosomal aberrations, such as translocations, losses, and gains. Molecular genetics targets small changes such as gene mutations (single base exchanges in the genome). In addition, Molecular genetic analyses can detect fusion transcripts resulting from structural changes, which are very useful as progression markers. While Cytogenetics and FISH are based on the evaluation of single cells, Molecular genetics always examines the DNA or RNA of bulk isolated cells.

The del(17p) is detected via FISH analysis and reveals losses of chromosome 17, where the TP53 gene is located. Thus, as part of this chromosomal loss, a copy of the TP53 gene is lost. Molecular genetics, on the other hand, specifically examines mutations in the TP53 gene that result in loss of function of the gene/protein. Independently of each other, both aberrations indicate a prognostically unfavorable influence in CLL, which is why both analyses should always be performed.

The costs for our analyses strictly follow the German EBM and GOÄ codes and can be viewed there. The costs can be requested by e-mail (buchhaltung@mll.com) or by phone at +49-89-99017-500.

The local/German health insurances cover the costs of all analyses for their insured persons, so that there are no costs for the patient. However, this might be different in other countries and should be clarified within the respective country.

The local/German private health insurances cover the costs of all analyses for their insured persons, so that there are no costs for the patient. However, this might be different in other countries and should be clarified within the respective country.

Processing times differ depending on the method used. For example, the range is from 24 hours after sample receipt for Cytomorphology and Immunophenotyping, to 3 days for FISH analysis, 7 days for Chromosome analysis and 3-10 days for Molecular genetics. An exception to this is suspected AML M3/APL, where PCR analysis takes 4-6 hours. The times can also be found in the Service section of our website.

In our order-entry-portal as well as our clinical-report-portal there is a lab book that shows the status of the sample (lab book status display).

PCR analysis for the detection of AML M3/APL (PML-RARA fusion) takes 4-6 hours after sample receipt.

Molecular genetics reports the result of FLT3-ITD analysis within 48 hours after sample receipt. Other analyses that impact the treatment decision are always reported in advance, regardless of the completion of the overall diagnostic analyses, as soon as the result of such an analysis is available.

In addition to the order-entry-portal (digital transmission of examination orders), we also offer a clinical-report-portal via which you can find the reports of your patients collectively and filter and search them accordingly.

For the diagnosis of AML and MDS we offer an integrated report covering all analyses. However, we can only create this report if we have performed BM and PB for Cytomorphology and also analyses of Immunophenotyping, Cytogenetics and Molecular genetics, since the definite diagnosis and prognosis can only be assessed when all methods are combined.

Yes, you can also receive the previous results/reports of your patient from prior sample submitters.