CAPABILITIES · SPECIALIST SAMPLE MATRICES · NOVEL MATRIX VALIDATION

If your sample is not plasma or serum, we want to hear about it

Difficult matrices need a different discipline: sensitivity that resolves a fraction of the concentration found in blood, validation in the matrix itself, and the willingness to build a workflow where none exists commercially.

That is the work we ask for.

Talk to a scientist about your matrix

Request a feasibility assessment

CAPABILITIES · SPECIALIST SAMPLE MATRICES · NOVEL MATRIX VALIDATION

If your sample is not plasma or serum, we want to hear about it

Difficult matrices need a different discipline: sensitivity that resolves a fraction of the concentration found in blood, validation in the matrix itself, and the willingness to build a workflow where none exists commercially.

That is the work we ask for.

Talk to a scientist about your matrix

Request a feasibility assessment

Validated workflows in EBC and dermal ISF

Validated workflows in EBC and dermal ISF

Validated workflows in EBC and dermal ISF

Single-plate pilot before you commit

Single-plate pilot before you commit

Single-plate pilot before you commit

Joint application notes published

Joint application notes published

Joint application notes published

HTA licensed, GCP compliant

HTA licensed, GCP compliant

HTA licensed, GCP compliant

Start with your matrix

Tell us what you are collecting, the volumes involved, the buffers and additives, and the markers you care about. We will give you a straight view on feasibility before anything is committed. That reply comes within one working day.

If we do not think it will work, we will tell you before you have paid for anything.

Send us your matrix details

WHAT IS novel matrix validation

Built for the matrices conventional workflows leave behind

We are a specialist biomarker CRO built around ultra-sensitive detection, NULISA, Simoa and MSD, and around the matrices that require it.

Exhaled breath. Dermal interstitial fluid. Sputum. Nasal lining fluid. Bronchoalveolar lavage fluid.

Sample types with no established protocol, no reference data, and no commercial workflow behind them.

That is what we are here for.

We are a specialist biomarker CRO built around ultra-sensitive detection, NULISA, Simoa and MSD, and around the matrices that require it.

Exhaled breath. Dermal interstitial fluid. Sputum. Nasal lining fluid. Bronchoalveolar lavage fluid fluid.

Sample types with no established protocol, no reference data, and no commercial workflow behind them.

That is what we are here for.

the problem

Why difficult matrices defeat conventional assays

The same problems recur across almost every unconventional sample type, in different combinations.

Concentration

Concentration

Analytes present at a fraction of their plasma concentration, often at or below the limit of detection of a conventional immunoassay.

Volume

Volume

Microlitres, or in some collection formats nanograms of total protein, against panels designed for hundreds of microlitres of serum.

Dilution

Dilution

Uncontrolled and unknowable. Lavage saline, elution buffer, breath condensation, with no denominator you can fully trust.

Interference

Interference

Detergents, reducing agents, protease inhibitors and mucins. All necessary to make the sample handleable, all hostile to antibody-based detection.

No reference data

No reference data

Nothing published to compare against, no expected ranges, no prior evidence that the markers you want are even present.


There are three usual ways out: dilute the sample, narrow the panel, or decline the project. All three throw away the reason you chose the matrix in the first place.

why novel matrix validation

From unproven matrix to published evidence

Exhaled breath condensate

The question: A breath device developer needed to know whether their device recovered enough protein to measure anything meaningful. There was no established protocol and no reference data.

What we did: Profiled a full plate of samples on a 250-protein inflammation panel, validated the method and established detectability in EBC.

The outcome: A published application note, and a device we now own. The validation became the foundation of our PBM-Hale™ platform.

Profile amyloid, multiple tau species, NfL, GFAP, synaptic proteins and neuroinflammatory mediators from a single CSF or plasma draw.

Used in Alzheimer's disease, ALS, frontotemporal dementia, Parkinson's disease, Lewy body disease and rare neurological disorders.

Dermal interstitial fluid

The question: Could a 250-protein inflammation panel work on microlitre volumes of skin fluid collected by Ascilion’s PELSA microneedle device, a matrix with no established assay workflow?

What we did: Adapted and ran the workflow on dermal ISF, a compartment biologically distinct from blood.

The outcome: Two joint application notes, presented at the Dermatology Drug Development Europe Summit in Amsterdam.

The question: Could a 250-protein inflammation panel work on microlitre volumes of skin fluid collected by Ascilion’s PELSA microneedle device, a matrix with no established assay workflow?

What we did: Adapted and ran the workflow on dermal ISF, a compartment biologically distinct from blood.

The outcome: Two joint application notes, presented at the Dermatology Drug Development Europe Summit in Amsterdam.

Building a collection device and need proof it works? Talk to us early, while your protocol and sample handling can still change.

Read the application notes

FOR DEVICE DEVELOPERS

Working with device manufacturers

If you’re developing a collection device, you face a frustrating problem. When a marker doesn’t show up in your data, you can’t tell whether the device failed to collect it or the assay failed to detect it. One of those answers says your device doesn’t work, even when it does.

Separate device performance from assay limits

Ultra-sensitive detection takes the assay largely out of the equation. If a marker is missing, it is far more likely to reflect the sample than the measurement. That turns your device from something you argue for into something you can evidence.

A partner for unproven matrices

Validating new collection devices is a core part of what we do. We take on matrices with no established method and validate the approach properly, giving you data you can put in front of investors, regulators and pharma partners.

Talk to us about your device

how it works

How we validate a new matrix

A novel matrix is a method development problem, and we treat it as one. The sequence below is how a sample type nobody has measured before becomes data you can publish.

01

Feasibility assessment

Before anything is committed, we look at what you are collecting, the volumes involved, buffers and additives, and the markers you care about. If it will not work, you hear that here, before any money is committed.

02

Single-plate pilot

We test the matrix on one plate before anyone commits to a full cohort. It is the smallest commitment that gives a real answer, and it is priced as a way in.

03

Normalisation strategy

EBC presents a normalisation challenge: droplet formation varies between individuals. Two subjects breathing the same protocol do not necessarily dilute their airway lining fluid to the same degree. Resolve it before the dataset is interpreted.

04

Platform selection

Whether the answer is broad ultra-sensitive profiling, defined single-plex quantification, validated multiplex, or bespoke matrix validation.

Start with a scoping conversation

Matrices we work in

From the nose to the alveolus, the skin surface to the dermis, and from preclinical models to clinical cohorts.

Respiratory

Respiratory

Exhaled breath condensate

Validated in-house on our own collection device

Nasal lining fluid

Non-invasive sampling of the upper airway

Sputum

Analysed neat, without dilution

Bronchoalveolar lavage fluid

Bronchoalveolar lavage fluid fluid

Broad profiling from a single, precious sample

Tracheal aspirate

Lower-airway sampling in intubated patients

Dermal

Dermal

Dermal interstitial fluid

Microneedle collection, validated in-house with a device developer

Skin tape strips

Non-invasive sampling of the stratum corneum

Ocular

Ocular

Tear fluid

Non-invasive sampling of the ocular surface

Aqueous humour

Direct measurement from the eye’s anterior chamber

Blood and CSF

Blood and CSF

Plasma and serum

Plasma and serum

Dried blood spots

Dried plasma spots

Cerebrospinal fluid

Other body fluids

Other body fluids

Urine

Urine

Saliva

Synovial fluid

Stool

Urine

Cells, tissues and vesicles

Brain and tissue lysates

Cell culture extracts

Total extracellular vesicles

Cell-derived extracellular vesicles

Preclinical

Preclinical

Non-human primate plasma and CSF

Mouse plasma, CSF, brain lysates and interstitial fluid

Mouse plasma, CSF, brain lysates and interstitial fluid

Rat plasma and CSF

Rat plasma and CSF

Established matrices

Specialist and conventional samples run on the same platforms, in the same laboratory, so a study mixing both never needs to be split across providers.

THE ALTHEOME DIFFERENCE

Why partner with Altheome on novel matrices

Ultra-sensitive by default

We have done this before

Protocol input before you collect

Speed

Confidentiality

Straight answers

New matrices are often dilute or low-volume, so we start with platforms that detect proteins at attomolar levels and profile up to around 340 targets from microlitre inputs. Where you need absolute numbers for a defined set of markers, we switch to a quantitative assay and explain why.

We are the UK’s first Alamar Certified Service Provider, and one of only five laboratories worldwide certified for NULISA custom assay development.


Talk to a scientist

THE ALTHEOME DIFFERENCE

Why partner with Altheome on novel matrices

Ultra-sensitive by default

We have done this before

Protocol input before you collect

Speed

Confidentiality

Straight answers

New matrices are often dilute or low-volume, so we start with platforms that detect proteins at attomolar levels and profile up to around 340 targets from microlitre inputs. Where you need absolute numbers for a defined set of markers, we switch to a quantitative assay and explain why.

We are the UK’s first Alamar Certified Service Provider, and one of only five laboratories worldwide certified for NULISA custom assay development.


Talk to a scientist

THE ALTHEOME DIFFERENCE

Why partner with Altheome on novel matrices

Ultra-sensitive by default

We have done this before

Protocol input before you collect

Speed

Confidentiality

Straight answers

New matrices are often dilute or low-volume, so we start with platforms that detect proteins at attomolar levels and profile up to around 340 targets from microlitre inputs. Where you need absolute numbers for a defined set of markers, we switch to a quantitative assay and explain why.

We are the UK’s first Alamar Certified Service Provider, and one of only five laboratories worldwide certified for NULISA custom assay development.


Talk to a scientist

We know collection from the device side

We have run validation programmes with device developers, including Ascilion on dermal interstitial fluid. We now own an EBC device, PBM-Hale™, and its intellectual property.


That gives us a perspective most laboratories don’t have. We know how collection goes wrong before a sample ever reaches the bench, and we design your validation to catch it.

We run Simoa on the SR-X alongside NULISA, MSD and sequencing.

All of them are ours, so the recommendation you get is a scientific one. If your target is better served by NULISA or MSD we will say so, and the work stays with us either way.



Homebrew development means we are not limited to the catalogue.


Where no commercial Simoa assay exists for your target, we can build one.

Quality, traceability and study readiness

Documented SOPs

Full sample chain of custody

GCP-compliant workflows

HTA licence 12818, the UK framework governing the storage and use of human tissue

Aligned to ISO 15189, the international standard for medical laboratories

For research use only. Not for use in diagnostic procedures.

Discuss your matrix with a scientist

Send us your matrix, volumes, collection method and the markers that matter.

We will give you a straight view on feasibility, the right platform and a timeline before you commit anything, including the answer that it cannot be done, if that is the answer.

Talk to a scientist about your matrix

Request a feasibility assessment

Building a collection device? Expect a reply inside one working day.

Building a collection device? Expect a reply inside one working day.

Related plataforms
Related capabilities
Related matrices

Still curious? Find answers in our FAQ's.

FAQ page

Related plataforms
Related capabilities
Related matrices

Still curious? Find answers in our FAQ's.

FAQ page

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