DRAFT MOCKUP, not live
Dysbiosis · Precision-matched FMT · Practitioner supply

A defined protocol.
Measured results.

Test. Restore. Re-test. Precision-matched FMT for licensed practitioners: a defined four-bottle Microbiome Restoration Protocol, guided by precision testing. Each patient’s baseline deep sequencing is matched to a donor using our proprietary donor matching algorithm, and product is manufactured on demand for that named patient under a Health Canada Drug Establishment Licence.

Novel Biome laboratory and clean room entry. Photo from current novelbiome.com, to be replaced by Malin’s shoot.
Photo from current novelbiome.com, to be replaced by Malin’s shoot
01 / LicenceCanada’s first DEL-licensed human FMT manufacturer
02 / StandardsGMP manufacturing, GLP laboratory practice
03 / TestingIn-house finished product testing on every lot
04 / FormatOral first. No procedure required.
Precision donor matching

Not just any donor. A matched donor.

Conventional FMT treats every patient the same way. Novel Biome starts with the patient’s own microbiome and matches the donor to it.

CONVENTIONAL FMT

One size fits all.

Any screened donor, any patient. The donor is chosen without looking at the patient’s own microbiome.

NOVEL BIOME / PRECISION DONOR MATCHING

The donor is matched to the patient.

Each patient’s baseline deep sequencing is matched to a donor using our proprietary donor matching algorithm, built on current microbiome science, which improves as more patients are treated. Designed for the best possible match, aiming for the best possible outcomes. [Foley Hoag: review “proprietary algorithm that improves as more patients are treated”]

Donor matching is part of how product is selected for each patient. It is not a diagnosis and does not predict an individual result. Clinical decisions remain with the treating practitioner.

Start with dysbiosis

One underlying imbalance. One defined approach.

Dysbiosis describes a disruption in the balance of the gut microbial community. Instead of separate approaches for each condition, Novel Biome is organized around a single, standardized Microbiome Restoration Protocol that practitioners can apply consistently and measure the same way every time.

[Greg: regulatory definition of dysbiosis, state vs condition, before publishing]

01

Consistent by design

One protocol, the same steps for every case, with the donor matched to each patient. Simpler to implement in a busy practice and easier to explain to patients.

02

Measured, not assumed

Deep shotgun metagenomic sequencing at baseline and follow-up gives you an objective view of the microbiome before and after the course.

03

Comparable across clinics

Standardized steps produce standardized data, so cases can be documented and reviewed the same way across our practitioner network.

How the protocol works

Test. Restore. Re-test.

Every Microbiome Restoration Protocol is bracketed by deep genome sequencing. The baseline result is also used to match your patient to a donor, so you start with data, match with data and finish with data.

STEP 01 / BASELINE

Test

Your patient completes a CM Bio stool test using deep shotgun metagenomic sequencing. You receive the report before the protocol begins.

CM Bio sequencing
STEP 02 / DONOR MATCH

Match

Our proprietary donor matching algorithm matches your patient’s baseline profile to a donor from our screened donor pool.

Precision-matched
STEP 03 / PROTOCOL

Restore

After recommended pre-treatment, three months of the four-bottle Microbiome Restoration Protocol, manufactured on demand for your named patient from the matched donor and shipped cold chain with handling instructions.

4 bottles
STEP 04 / FOLLOW-UP

Re-test

A follow-up CM Bio test one month after FMT ends shows how the microbiome has changed, documented alongside your own clinical assessment.

CM Bio sequencing
See the protocol →● Test and protocol pricing visible after registration
Donor program & quality

How every lot is made and released.

Donor selection, testing, quarantine and release follow written procedures under our Health Canada Drug Establishment Licence. Full parameters are provided to registered practitioners.

STAGE 01

Donor assessment

Medical history, lifestyle and medication review against written exclusion criteria.

STAGE 02

Laboratory screening

Stool screening first, then blood and urine panels, on a defined schedule.

STAGE 03

Quarantine

Material is held until the applicable testing cycle is complete.

STAGE 04

Release

Finished product is tested in-house and released against specification.

Practitioner education

Learn the protocol with the people who built it.

Live webinars, recorded sessions and recurring office hours for registered practitioners. Bring a real case and talk it through with our team.

JAN
[TBC]
Launch webinar: the Microbiome Restoration Protocol
Shaina Cahill, Ph.D. and Jason Klop · [week of Jan 18, date TBC]
MONTHLY
Practitioner office hours
Case questions, sequencing reports, logistics
ON DEMAND
Reading a CM Bio sequencing report
Recorded session · registered practitioners
Your clinical team

You will know who you are calling.

Partner support is not a ticket queue. The same small team handles onboarding, protocol questions and case discussions.

Jason Klop. Photo from current novelbiome.com, to be replaced by Malin’s shoot.
Photo from current novelbiome.com, to be replaced by Malin’s shoot

Jason Klop

Founder & CEO

Leads protocol design and case review for partner clinics. [verify: bio wording]

Shaina Cahill. Photo from current novelbiome.com, to be replaced by Malin’s shoot.
Photo from current novelbiome.com, to be replaced by Malin’s shoot

Shaina Cahill, Ph.D.

Director of Operations & Medical Affairs

Oversees donor screening, research and quality systems.

Sarah Douglas. Photo from current novelbiome.com, to be replaced by Malin’s shoot.
Photo from current novelbiome.com, to be replaced by Malin’s shoot

Sarah Douglas, R.H.N.

Client Success & Account Manager

Your first call. Sarah runs onboarding, account approval and ongoing support for every partner clinic.

How your account works
01

Qualify

Tell us your role, licence and where you practise.

02

Onboarding call

A short call with Sarah on the protocol, sequencing, donor matching, ordering and patient handouts.

03

Approved account

Pricing, the Protocol Book, CM Bio test ordering, sub-accounts and education, in one place.